Tobacco CessationJudith J Prochaska PhD MPHProfessor of MedicineStanford University
2
A MESSAGE FROM US SURGEON GENERAL JEROME ADAMS
3
DISCLOSURESCurrent Funding NHLBI R01HL117736 NCI R01CA204356 R01CA217165 and P01CA225597 NCI Moonshot Suppl P30CA124435 NIDA UHAG052168 R34DA046008 R21DA042222 and R44DA04871
Consulting Consultant to pharmaceutical (Pfizer Achieve Life Sciences) and technology companies (Carrot) focused on helping people quit smoking expert witness for plaintiff counsel in litigation against the tobacco companies
4
Learning Objectivesevolution of the tobacco product landscapeDescribe
fundamentals of tobacco use health effects and nicotine addictionDiscuss
combined behavioral amp pharmacological treatment best practicesUnderstand
newer strategies with cessation medications amp behavioral treatmentsDescribe
brief motivational approaches for client engagement amp referralDiscuss
key conclusions of 2020 Surgeon General Report on Smoking CessationSummarize
gaps in the treatment literature and future directionsIdentify
5
OverviewEpidemiology nicotine product landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
6
OverviewEpidemiology nicotine product landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
bull For US adults cigarettes are by far the most common form of tobacco
bull All forms of tobacco are harmful
bull The safetyefficacy of e-cigarettes is not established
bull E-cigarettes have increased in their efficiency of nicotine delivery
bull Clinical attention to all forms of tobacco is needed
10
US ADULT SMOKING by SEX 1955ndash2018
Graph provided by the Centers for Disease Control and Prevention 1955 Current Population Survey 1965ndash2018 NHIS Estimates since 1992 include some-day smoking
2017 NHIS US Adults Current Ecig Use by Race6 Multi-racial3 non-Hispanic White2 non-Hispanic Black2 Hispanic1 non-Hispanic Asian
14
Q True or False
A FalseNearly 70 of adults who smoke report wanting to quit
Most adults who smoke do not want to quit
15
Youth Tobacco Use Patterns NYTS 2019
bull 2019 Monitoring the Future study 1 in 9 HS seniors (117) vaped nicotine nearly daily bull NHIS 2018 32 of adults currently used e-cigs every day or some days
16
17
FDA Ecig Flavor Restrictionbull Prohibits the sale of flavored cartridge-based e-cigs
other than menthol or tobacco flavorbull As of Feb 6 2020 many flavored e-liquid pods
including Juul and Juul-compatible products are no longer sold legally in US
bull The guidance does notndash Restrict all flavors ndash Address concept flavorsndash Include all e-cigs (tanksmods closed systems)ndash Apply to other tobacco products (eg cigars
cigarillos hookah)
X X X XX
18SOURCE MAYO
19
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
20
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
21
What is Addiction
ldquoCompulsive drug use without medical purpose in the face of negative consequencesrdquo
bull Other cataract diabetes (type 2) erectile dysfunction impaired immune function osteoporosis periodontitis postoperative complications rheumatoid arthritis
US Department of Health and Human Services (USDHHS) (2014)The Health Consequences of Smokingmdash50 Years of Progress A Report of the Surgeon General
25
SMOKING EPIDEMIOLOGY amp HARMS
26
E-cig Aerosol may Containbull Nicotine (even if marketed as 0 nicotine)bull Ultrafine particles that can be inhaled deep into the lungsbull Flavoring such as diacetyl a chemical linked to a serious lung dzbull Volatile organic compounds (VOCs)bull Cancer-causing chemicalsbull Heavy metals such as nickel tin and lead
Primary humectants are propylene glycol and glycerol (aka vegetable glycerin)
At lower levels than in combusted tobacco smoke
27
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
elevated white blood cell countsndash Injuries resembled ldquoexposures to
toxic chemical fumes poisonous gases and toxic agentsrdquo (Mayo)
A diagnosis of exclusion
bull Patient Recommendationsndash Do not use THC-containing vaping
products particularly from informal sources (eg friends family in-person or online sellers)
ndash Vitamin E acetate should not be added to vaping products
Krishnasamy et al (2020) MMWR
28
Reporting EVALI Casesbull CDC encourages clinicians to
continue to report possible EVALI cases to their local or state health department for further investigation
bull If EVALI suspected collect a detailed history ofndash Substances used ndash Sources of products ndash Duration and frequency of usendash Devices used and how used
EVALI Confirmed Case Criteria
29
30
USE amp HARMS SUMMARY
bull Fewer than 1 in 7 US adults are current smokers
bull Smoking prevalence varies by sociodemographic characteristics
bull Nearly half a million US deaths are attributable to smoking annually
bull Smoking costs the US an estimated $300 billion annually
bull E-cigarettes are a diverse product group and their health harms are still being determined
31
OverviewEpidemiology nicotine product landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
32
Counseling7 in 10 tobacco users see a healthcare provider in a given year
Treating tobacco is relevant to all areas of medicine
USPSTF ldquoGrade Ardquo recommendation for clinician-delivered brief tobacco treatment
Counseling by nonphysician health providers also increases quit rates
33
National Cancer Institutersquos 5 As
ASK all patients about use of all forms of tobacco
1
ADVISEtobacco users to quit
2
ASSESS patient readiness to quit
3
ASSIST in the quit attempt with counseling medications amp referrals
ndash Intensive counseling only (without medications) more effective than minimal contact (ie brief advice + self-help materials)
ndash Greater effects when combined with cessation medications
37
COUNSELING SUMMARYbull Routinely identify tobacco users (ASK)bull Strongly ADVISE patients to quitbull ASSESS readiness to quit at each contactbull Tailor intervention messages (ASSIST)
ndash Be a good listenerndash Minimal intervention in absence of time for more
intensive interventionbull ARRANGE follow-up
ndash Use the referral process if needed
38
Tobacco Quitlinesbull Toll-free national portal
ndash Links to state quitline by area code
bull Trained counselors providingndash information self-help materialsndash individual counselingndash local referralsndash may provide free cessation meds
bull Effectiveness well demonstrated bull Reach ~1 of smokers annually
39
Internet Interventionsbull Increasing sophistication + interactionbull Best Practices Individual tailoring
bull Smokefreegovndash Evidence-based tailored to readiness to quitndash Assistance via IM + phone (1-877-44U-QUIT)ndash SmokefreeTXT + Smokefree smartphone
bull Tailored versions for veterans women teens Spanish-speaking and older adults
bull Relative to quitlinesndash 27 Xs greater reach [annually 11 M vs 400K]ndash at a lower cost per quit [$291 vs $900]Smokefreegov
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
Varenicline
Bupropion
NRT
Placebo
Overall (N= 8058)
4
45
39
37
NPC (N = 3984)
13
22
25
24
PC (N = 4074)
65
67
52
49
To resize chart data range drag lower right corner of range
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
Varenicline
Bupropion
NRT
Placebo
Weeks 9ndash12
38
261
264
137
Weeks 9ndash24
255
188
185
105
Weeks 9ndash12
292
193
204
114
Weeks 9ndash24
183
137
13
83
Weeks 9ndash12
335
226
234
125
Weeks 9ndash24
218
162
157
94
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Men
Women
1955
542
245
1956
1957
1958
1959
1960
1961
1962
1963
1964
1965
519
339
1966
525
339
1967
1968
1969
1970
441
315
1971
1972
1973
1974
431
321
1975
1976
419
32
1977
409
321
1978
381
307
1979
375
299
1980
376
293
1981
1982
1983
351
295
1984
1985
326
279
1986
1987
312
265
1988
308
257
1989
1990
284
228
1991
281
235
1992
286
246
1993
277
225
1994
282
231
1995
27
226
1997
276
221
1998
264
22
1999
257
215
2000
257
21
2001
252
207
2002
252
20
2003
241
192
2004
234
185
2005
239
181
2006
239
18
2007
223
174
2008
231
183
2009
235
179
2010
215
173
2011
216
165
2012
205
158
2013
205
153
2014
188
148
2015
167
136
2016
175
135
2017
158
122
2018
156
12
1955
1955
1956
1956
1957
1957
1958
1958
1959
1959
1960
1960
1961
1961
1962
1962
1963
1963
1964
1964
1965
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1968
1969
1969
1970
1970
1971
1971
1972
1972
1973
1973
1974
1974
1975
1975
1976
1976
1977
1977
1978
1978
1979
1979
1980
1980
1981
1981
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1982
1983
1983
1984
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1988
1989
1989
1990
1990
1991
1991
1992
1992
1993
1993
1994
1994
1995
1995
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1997
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1998
1999
1999
2000
2000
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2002
2003
2003
2004
2004
2005
2005
2006
2006
2007
2007
2008
2008
2009
2009
2010
2010
2011
2011
2012
2012
2013
2013
2014
2014
2015
2015
2016
2016
2017
2017
2018
2018
2
A MESSAGE FROM US SURGEON GENERAL JEROME ADAMS
3
DISCLOSURESCurrent Funding NHLBI R01HL117736 NCI R01CA204356 R01CA217165 and P01CA225597 NCI Moonshot Suppl P30CA124435 NIDA UHAG052168 R34DA046008 R21DA042222 and R44DA04871
Consulting Consultant to pharmaceutical (Pfizer Achieve Life Sciences) and technology companies (Carrot) focused on helping people quit smoking expert witness for plaintiff counsel in litigation against the tobacco companies
4
Learning Objectivesevolution of the tobacco product landscapeDescribe
fundamentals of tobacco use health effects and nicotine addictionDiscuss
combined behavioral amp pharmacological treatment best practicesUnderstand
newer strategies with cessation medications amp behavioral treatmentsDescribe
brief motivational approaches for client engagement amp referralDiscuss
key conclusions of 2020 Surgeon General Report on Smoking CessationSummarize
gaps in the treatment literature and future directionsIdentify
5
OverviewEpidemiology nicotine product landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
6
OverviewEpidemiology nicotine product landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
bull For US adults cigarettes are by far the most common form of tobacco
bull All forms of tobacco are harmful
bull The safetyefficacy of e-cigarettes is not established
bull E-cigarettes have increased in their efficiency of nicotine delivery
bull Clinical attention to all forms of tobacco is needed
10
US ADULT SMOKING by SEX 1955ndash2018
Graph provided by the Centers for Disease Control and Prevention 1955 Current Population Survey 1965ndash2018 NHIS Estimates since 1992 include some-day smoking
2017 NHIS US Adults Current Ecig Use by Race6 Multi-racial3 non-Hispanic White2 non-Hispanic Black2 Hispanic1 non-Hispanic Asian
14
Q True or False
A FalseNearly 70 of adults who smoke report wanting to quit
Most adults who smoke do not want to quit
15
Youth Tobacco Use Patterns NYTS 2019
bull 2019 Monitoring the Future study 1 in 9 HS seniors (117) vaped nicotine nearly daily bull NHIS 2018 32 of adults currently used e-cigs every day or some days
16
17
FDA Ecig Flavor Restrictionbull Prohibits the sale of flavored cartridge-based e-cigs
other than menthol or tobacco flavorbull As of Feb 6 2020 many flavored e-liquid pods
including Juul and Juul-compatible products are no longer sold legally in US
bull The guidance does notndash Restrict all flavors ndash Address concept flavorsndash Include all e-cigs (tanksmods closed systems)ndash Apply to other tobacco products (eg cigars
cigarillos hookah)
X X X XX
18SOURCE MAYO
19
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
20
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
21
What is Addiction
ldquoCompulsive drug use without medical purpose in the face of negative consequencesrdquo
bull Other cataract diabetes (type 2) erectile dysfunction impaired immune function osteoporosis periodontitis postoperative complications rheumatoid arthritis
US Department of Health and Human Services (USDHHS) (2014)The Health Consequences of Smokingmdash50 Years of Progress A Report of the Surgeon General
25
SMOKING EPIDEMIOLOGY amp HARMS
26
E-cig Aerosol may Containbull Nicotine (even if marketed as 0 nicotine)bull Ultrafine particles that can be inhaled deep into the lungsbull Flavoring such as diacetyl a chemical linked to a serious lung dzbull Volatile organic compounds (VOCs)bull Cancer-causing chemicalsbull Heavy metals such as nickel tin and lead
Primary humectants are propylene glycol and glycerol (aka vegetable glycerin)
At lower levels than in combusted tobacco smoke
27
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
elevated white blood cell countsndash Injuries resembled ldquoexposures to
toxic chemical fumes poisonous gases and toxic agentsrdquo (Mayo)
A diagnosis of exclusion
bull Patient Recommendationsndash Do not use THC-containing vaping
products particularly from informal sources (eg friends family in-person or online sellers)
ndash Vitamin E acetate should not be added to vaping products
Krishnasamy et al (2020) MMWR
28
Reporting EVALI Casesbull CDC encourages clinicians to
continue to report possible EVALI cases to their local or state health department for further investigation
bull If EVALI suspected collect a detailed history ofndash Substances used ndash Sources of products ndash Duration and frequency of usendash Devices used and how used
EVALI Confirmed Case Criteria
29
30
USE amp HARMS SUMMARY
bull Fewer than 1 in 7 US adults are current smokers
bull Smoking prevalence varies by sociodemographic characteristics
bull Nearly half a million US deaths are attributable to smoking annually
bull Smoking costs the US an estimated $300 billion annually
bull E-cigarettes are a diverse product group and their health harms are still being determined
31
OverviewEpidemiology nicotine product landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
32
Counseling7 in 10 tobacco users see a healthcare provider in a given year
Treating tobacco is relevant to all areas of medicine
USPSTF ldquoGrade Ardquo recommendation for clinician-delivered brief tobacco treatment
Counseling by nonphysician health providers also increases quit rates
33
National Cancer Institutersquos 5 As
ASK all patients about use of all forms of tobacco
1
ADVISEtobacco users to quit
2
ASSESS patient readiness to quit
3
ASSIST in the quit attempt with counseling medications amp referrals
ndash Intensive counseling only (without medications) more effective than minimal contact (ie brief advice + self-help materials)
ndash Greater effects when combined with cessation medications
37
COUNSELING SUMMARYbull Routinely identify tobacco users (ASK)bull Strongly ADVISE patients to quitbull ASSESS readiness to quit at each contactbull Tailor intervention messages (ASSIST)
ndash Be a good listenerndash Minimal intervention in absence of time for more
intensive interventionbull ARRANGE follow-up
ndash Use the referral process if needed
38
Tobacco Quitlinesbull Toll-free national portal
ndash Links to state quitline by area code
bull Trained counselors providingndash information self-help materialsndash individual counselingndash local referralsndash may provide free cessation meds
bull Effectiveness well demonstrated bull Reach ~1 of smokers annually
39
Internet Interventionsbull Increasing sophistication + interactionbull Best Practices Individual tailoring
bull Smokefreegovndash Evidence-based tailored to readiness to quitndash Assistance via IM + phone (1-877-44U-QUIT)ndash SmokefreeTXT + Smokefree smartphone
bull Tailored versions for veterans women teens Spanish-speaking and older adults
bull Relative to quitlinesndash 27 Xs greater reach [annually 11 M vs 400K]ndash at a lower cost per quit [$291 vs $900]Smokefreegov
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
Varenicline
Bupropion
NRT
Placebo
Overall (N= 8058)
4
45
39
37
NPC (N = 3984)
13
22
25
24
PC (N = 4074)
65
67
52
49
To resize chart data range drag lower right corner of range
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
Varenicline
Bupropion
NRT
Placebo
Weeks 9ndash12
38
261
264
137
Weeks 9ndash24
255
188
185
105
Weeks 9ndash12
292
193
204
114
Weeks 9ndash24
183
137
13
83
Weeks 9ndash12
335
226
234
125
Weeks 9ndash24
218
162
157
94
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Men
Women
1955
542
245
1956
1957
1958
1959
1960
1961
1962
1963
1964
1965
519
339
1966
525
339
1967
1968
1969
1970
441
315
1971
1972
1973
1974
431
321
1975
1976
419
32
1977
409
321
1978
381
307
1979
375
299
1980
376
293
1981
1982
1983
351
295
1984
1985
326
279
1986
1987
312
265
1988
308
257
1989
1990
284
228
1991
281
235
1992
286
246
1993
277
225
1994
282
231
1995
27
226
1997
276
221
1998
264
22
1999
257
215
2000
257
21
2001
252
207
2002
252
20
2003
241
192
2004
234
185
2005
239
181
2006
239
18
2007
223
174
2008
231
183
2009
235
179
2010
215
173
2011
216
165
2012
205
158
2013
205
153
2014
188
148
2015
167
136
2016
175
135
2017
158
122
2018
156
12
1955
1955
1956
1956
1957
1957
1958
1958
1959
1959
1960
1960
1961
1961
1962
1962
1963
1963
1964
1964
1965
1965
1966
1966
1967
1967
1968
1968
1969
1969
1970
1970
1971
1971
1972
1972
1973
1973
1974
1974
1975
1975
1976
1976
1977
1977
1978
1978
1979
1979
1980
1980
1981
1981
1982
1982
1983
1983
1984
1984
1985
1985
1986
1986
1987
1987
1988
1988
1989
1989
1990
1990
1991
1991
1992
1992
1993
1993
1994
1994
1995
1995
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1997
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1998
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1999
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2000
2001
2001
2002
2002
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2003
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2005
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2008
2008
2009
2009
2010
2010
2011
2011
2012
2012
2013
2013
2014
2014
2015
2015
2016
2016
2017
2017
2018
2018
3
DISCLOSURESCurrent Funding NHLBI R01HL117736 NCI R01CA204356 R01CA217165 and P01CA225597 NCI Moonshot Suppl P30CA124435 NIDA UHAG052168 R34DA046008 R21DA042222 and R44DA04871
Consulting Consultant to pharmaceutical (Pfizer Achieve Life Sciences) and technology companies (Carrot) focused on helping people quit smoking expert witness for plaintiff counsel in litigation against the tobacco companies
4
Learning Objectivesevolution of the tobacco product landscapeDescribe
fundamentals of tobacco use health effects and nicotine addictionDiscuss
combined behavioral amp pharmacological treatment best practicesUnderstand
newer strategies with cessation medications amp behavioral treatmentsDescribe
brief motivational approaches for client engagement amp referralDiscuss
key conclusions of 2020 Surgeon General Report on Smoking CessationSummarize
gaps in the treatment literature and future directionsIdentify
5
OverviewEpidemiology nicotine product landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
6
OverviewEpidemiology nicotine product landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
bull For US adults cigarettes are by far the most common form of tobacco
bull All forms of tobacco are harmful
bull The safetyefficacy of e-cigarettes is not established
bull E-cigarettes have increased in their efficiency of nicotine delivery
bull Clinical attention to all forms of tobacco is needed
10
US ADULT SMOKING by SEX 1955ndash2018
Graph provided by the Centers for Disease Control and Prevention 1955 Current Population Survey 1965ndash2018 NHIS Estimates since 1992 include some-day smoking
2017 NHIS US Adults Current Ecig Use by Race6 Multi-racial3 non-Hispanic White2 non-Hispanic Black2 Hispanic1 non-Hispanic Asian
14
Q True or False
A FalseNearly 70 of adults who smoke report wanting to quit
Most adults who smoke do not want to quit
15
Youth Tobacco Use Patterns NYTS 2019
bull 2019 Monitoring the Future study 1 in 9 HS seniors (117) vaped nicotine nearly daily bull NHIS 2018 32 of adults currently used e-cigs every day or some days
16
17
FDA Ecig Flavor Restrictionbull Prohibits the sale of flavored cartridge-based e-cigs
other than menthol or tobacco flavorbull As of Feb 6 2020 many flavored e-liquid pods
including Juul and Juul-compatible products are no longer sold legally in US
bull The guidance does notndash Restrict all flavors ndash Address concept flavorsndash Include all e-cigs (tanksmods closed systems)ndash Apply to other tobacco products (eg cigars
cigarillos hookah)
X X X XX
18SOURCE MAYO
19
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
20
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
21
What is Addiction
ldquoCompulsive drug use without medical purpose in the face of negative consequencesrdquo
bull Other cataract diabetes (type 2) erectile dysfunction impaired immune function osteoporosis periodontitis postoperative complications rheumatoid arthritis
US Department of Health and Human Services (USDHHS) (2014)The Health Consequences of Smokingmdash50 Years of Progress A Report of the Surgeon General
25
SMOKING EPIDEMIOLOGY amp HARMS
26
E-cig Aerosol may Containbull Nicotine (even if marketed as 0 nicotine)bull Ultrafine particles that can be inhaled deep into the lungsbull Flavoring such as diacetyl a chemical linked to a serious lung dzbull Volatile organic compounds (VOCs)bull Cancer-causing chemicalsbull Heavy metals such as nickel tin and lead
Primary humectants are propylene glycol and glycerol (aka vegetable glycerin)
At lower levels than in combusted tobacco smoke
27
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
elevated white blood cell countsndash Injuries resembled ldquoexposures to
toxic chemical fumes poisonous gases and toxic agentsrdquo (Mayo)
A diagnosis of exclusion
bull Patient Recommendationsndash Do not use THC-containing vaping
products particularly from informal sources (eg friends family in-person or online sellers)
ndash Vitamin E acetate should not be added to vaping products
Krishnasamy et al (2020) MMWR
28
Reporting EVALI Casesbull CDC encourages clinicians to
continue to report possible EVALI cases to their local or state health department for further investigation
bull If EVALI suspected collect a detailed history ofndash Substances used ndash Sources of products ndash Duration and frequency of usendash Devices used and how used
EVALI Confirmed Case Criteria
29
30
USE amp HARMS SUMMARY
bull Fewer than 1 in 7 US adults are current smokers
bull Smoking prevalence varies by sociodemographic characteristics
bull Nearly half a million US deaths are attributable to smoking annually
bull Smoking costs the US an estimated $300 billion annually
bull E-cigarettes are a diverse product group and their health harms are still being determined
31
OverviewEpidemiology nicotine product landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
32
Counseling7 in 10 tobacco users see a healthcare provider in a given year
Treating tobacco is relevant to all areas of medicine
USPSTF ldquoGrade Ardquo recommendation for clinician-delivered brief tobacco treatment
Counseling by nonphysician health providers also increases quit rates
33
National Cancer Institutersquos 5 As
ASK all patients about use of all forms of tobacco
1
ADVISEtobacco users to quit
2
ASSESS patient readiness to quit
3
ASSIST in the quit attempt with counseling medications amp referrals
ndash Intensive counseling only (without medications) more effective than minimal contact (ie brief advice + self-help materials)
ndash Greater effects when combined with cessation medications
37
COUNSELING SUMMARYbull Routinely identify tobacco users (ASK)bull Strongly ADVISE patients to quitbull ASSESS readiness to quit at each contactbull Tailor intervention messages (ASSIST)
ndash Be a good listenerndash Minimal intervention in absence of time for more
intensive interventionbull ARRANGE follow-up
ndash Use the referral process if needed
38
Tobacco Quitlinesbull Toll-free national portal
ndash Links to state quitline by area code
bull Trained counselors providingndash information self-help materialsndash individual counselingndash local referralsndash may provide free cessation meds
bull Effectiveness well demonstrated bull Reach ~1 of smokers annually
39
Internet Interventionsbull Increasing sophistication + interactionbull Best Practices Individual tailoring
bull Smokefreegovndash Evidence-based tailored to readiness to quitndash Assistance via IM + phone (1-877-44U-QUIT)ndash SmokefreeTXT + Smokefree smartphone
bull Tailored versions for veterans women teens Spanish-speaking and older adults
bull Relative to quitlinesndash 27 Xs greater reach [annually 11 M vs 400K]ndash at a lower cost per quit [$291 vs $900]Smokefreegov
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
bull For US adults cigarettes are by far the most common form of tobacco
bull All forms of tobacco are harmful
bull The safetyefficacy of e-cigarettes is not established
bull E-cigarettes have increased in their efficiency of nicotine delivery
bull Clinical attention to all forms of tobacco is needed
10
US ADULT SMOKING by SEX 1955ndash2018
Graph provided by the Centers for Disease Control and Prevention 1955 Current Population Survey 1965ndash2018 NHIS Estimates since 1992 include some-day smoking
2017 NHIS US Adults Current Ecig Use by Race6 Multi-racial3 non-Hispanic White2 non-Hispanic Black2 Hispanic1 non-Hispanic Asian
14
Q True or False
A FalseNearly 70 of adults who smoke report wanting to quit
Most adults who smoke do not want to quit
15
Youth Tobacco Use Patterns NYTS 2019
bull 2019 Monitoring the Future study 1 in 9 HS seniors (117) vaped nicotine nearly daily bull NHIS 2018 32 of adults currently used e-cigs every day or some days
16
17
FDA Ecig Flavor Restrictionbull Prohibits the sale of flavored cartridge-based e-cigs
other than menthol or tobacco flavorbull As of Feb 6 2020 many flavored e-liquid pods
including Juul and Juul-compatible products are no longer sold legally in US
bull The guidance does notndash Restrict all flavors ndash Address concept flavorsndash Include all e-cigs (tanksmods closed systems)ndash Apply to other tobacco products (eg cigars
cigarillos hookah)
X X X XX
18SOURCE MAYO
19
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
20
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
21
What is Addiction
ldquoCompulsive drug use without medical purpose in the face of negative consequencesrdquo
bull Other cataract diabetes (type 2) erectile dysfunction impaired immune function osteoporosis periodontitis postoperative complications rheumatoid arthritis
US Department of Health and Human Services (USDHHS) (2014)The Health Consequences of Smokingmdash50 Years of Progress A Report of the Surgeon General
25
SMOKING EPIDEMIOLOGY amp HARMS
26
E-cig Aerosol may Containbull Nicotine (even if marketed as 0 nicotine)bull Ultrafine particles that can be inhaled deep into the lungsbull Flavoring such as diacetyl a chemical linked to a serious lung dzbull Volatile organic compounds (VOCs)bull Cancer-causing chemicalsbull Heavy metals such as nickel tin and lead
Primary humectants are propylene glycol and glycerol (aka vegetable glycerin)
At lower levels than in combusted tobacco smoke
27
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
elevated white blood cell countsndash Injuries resembled ldquoexposures to
toxic chemical fumes poisonous gases and toxic agentsrdquo (Mayo)
A diagnosis of exclusion
bull Patient Recommendationsndash Do not use THC-containing vaping
products particularly from informal sources (eg friends family in-person or online sellers)
ndash Vitamin E acetate should not be added to vaping products
Krishnasamy et al (2020) MMWR
28
Reporting EVALI Casesbull CDC encourages clinicians to
continue to report possible EVALI cases to their local or state health department for further investigation
bull If EVALI suspected collect a detailed history ofndash Substances used ndash Sources of products ndash Duration and frequency of usendash Devices used and how used
EVALI Confirmed Case Criteria
29
30
USE amp HARMS SUMMARY
bull Fewer than 1 in 7 US adults are current smokers
bull Smoking prevalence varies by sociodemographic characteristics
bull Nearly half a million US deaths are attributable to smoking annually
bull Smoking costs the US an estimated $300 billion annually
bull E-cigarettes are a diverse product group and their health harms are still being determined
31
OverviewEpidemiology nicotine product landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
32
Counseling7 in 10 tobacco users see a healthcare provider in a given year
Treating tobacco is relevant to all areas of medicine
USPSTF ldquoGrade Ardquo recommendation for clinician-delivered brief tobacco treatment
Counseling by nonphysician health providers also increases quit rates
33
National Cancer Institutersquos 5 As
ASK all patients about use of all forms of tobacco
1
ADVISEtobacco users to quit
2
ASSESS patient readiness to quit
3
ASSIST in the quit attempt with counseling medications amp referrals
ndash Intensive counseling only (without medications) more effective than minimal contact (ie brief advice + self-help materials)
ndash Greater effects when combined with cessation medications
37
COUNSELING SUMMARYbull Routinely identify tobacco users (ASK)bull Strongly ADVISE patients to quitbull ASSESS readiness to quit at each contactbull Tailor intervention messages (ASSIST)
ndash Be a good listenerndash Minimal intervention in absence of time for more
intensive interventionbull ARRANGE follow-up
ndash Use the referral process if needed
38
Tobacco Quitlinesbull Toll-free national portal
ndash Links to state quitline by area code
bull Trained counselors providingndash information self-help materialsndash individual counselingndash local referralsndash may provide free cessation meds
bull Effectiveness well demonstrated bull Reach ~1 of smokers annually
39
Internet Interventionsbull Increasing sophistication + interactionbull Best Practices Individual tailoring
bull Smokefreegovndash Evidence-based tailored to readiness to quitndash Assistance via IM + phone (1-877-44U-QUIT)ndash SmokefreeTXT + Smokefree smartphone
bull Tailored versions for veterans women teens Spanish-speaking and older adults
bull Relative to quitlinesndash 27 Xs greater reach [annually 11 M vs 400K]ndash at a lower cost per quit [$291 vs $900]Smokefreegov
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
bull For US adults cigarettes are by far the most common form of tobacco
bull All forms of tobacco are harmful
bull The safetyefficacy of e-cigarettes is not established
bull E-cigarettes have increased in their efficiency of nicotine delivery
bull Clinical attention to all forms of tobacco is needed
10
US ADULT SMOKING by SEX 1955ndash2018
Graph provided by the Centers for Disease Control and Prevention 1955 Current Population Survey 1965ndash2018 NHIS Estimates since 1992 include some-day smoking
2017 NHIS US Adults Current Ecig Use by Race6 Multi-racial3 non-Hispanic White2 non-Hispanic Black2 Hispanic1 non-Hispanic Asian
14
Q True or False
A FalseNearly 70 of adults who smoke report wanting to quit
Most adults who smoke do not want to quit
15
Youth Tobacco Use Patterns NYTS 2019
bull 2019 Monitoring the Future study 1 in 9 HS seniors (117) vaped nicotine nearly daily bull NHIS 2018 32 of adults currently used e-cigs every day or some days
16
17
FDA Ecig Flavor Restrictionbull Prohibits the sale of flavored cartridge-based e-cigs
other than menthol or tobacco flavorbull As of Feb 6 2020 many flavored e-liquid pods
including Juul and Juul-compatible products are no longer sold legally in US
bull The guidance does notndash Restrict all flavors ndash Address concept flavorsndash Include all e-cigs (tanksmods closed systems)ndash Apply to other tobacco products (eg cigars
cigarillos hookah)
X X X XX
18SOURCE MAYO
19
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
20
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
21
What is Addiction
ldquoCompulsive drug use without medical purpose in the face of negative consequencesrdquo
bull Other cataract diabetes (type 2) erectile dysfunction impaired immune function osteoporosis periodontitis postoperative complications rheumatoid arthritis
US Department of Health and Human Services (USDHHS) (2014)The Health Consequences of Smokingmdash50 Years of Progress A Report of the Surgeon General
25
SMOKING EPIDEMIOLOGY amp HARMS
26
E-cig Aerosol may Containbull Nicotine (even if marketed as 0 nicotine)bull Ultrafine particles that can be inhaled deep into the lungsbull Flavoring such as diacetyl a chemical linked to a serious lung dzbull Volatile organic compounds (VOCs)bull Cancer-causing chemicalsbull Heavy metals such as nickel tin and lead
Primary humectants are propylene glycol and glycerol (aka vegetable glycerin)
At lower levels than in combusted tobacco smoke
27
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
elevated white blood cell countsndash Injuries resembled ldquoexposures to
toxic chemical fumes poisonous gases and toxic agentsrdquo (Mayo)
A diagnosis of exclusion
bull Patient Recommendationsndash Do not use THC-containing vaping
products particularly from informal sources (eg friends family in-person or online sellers)
ndash Vitamin E acetate should not be added to vaping products
Krishnasamy et al (2020) MMWR
28
Reporting EVALI Casesbull CDC encourages clinicians to
continue to report possible EVALI cases to their local or state health department for further investigation
bull If EVALI suspected collect a detailed history ofndash Substances used ndash Sources of products ndash Duration and frequency of usendash Devices used and how used
EVALI Confirmed Case Criteria
29
30
USE amp HARMS SUMMARY
bull Fewer than 1 in 7 US adults are current smokers
bull Smoking prevalence varies by sociodemographic characteristics
bull Nearly half a million US deaths are attributable to smoking annually
bull Smoking costs the US an estimated $300 billion annually
bull E-cigarettes are a diverse product group and their health harms are still being determined
31
OverviewEpidemiology nicotine product landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
32
Counseling7 in 10 tobacco users see a healthcare provider in a given year
Treating tobacco is relevant to all areas of medicine
USPSTF ldquoGrade Ardquo recommendation for clinician-delivered brief tobacco treatment
Counseling by nonphysician health providers also increases quit rates
33
National Cancer Institutersquos 5 As
ASK all patients about use of all forms of tobacco
1
ADVISEtobacco users to quit
2
ASSESS patient readiness to quit
3
ASSIST in the quit attempt with counseling medications amp referrals
ndash Intensive counseling only (without medications) more effective than minimal contact (ie brief advice + self-help materials)
ndash Greater effects when combined with cessation medications
37
COUNSELING SUMMARYbull Routinely identify tobacco users (ASK)bull Strongly ADVISE patients to quitbull ASSESS readiness to quit at each contactbull Tailor intervention messages (ASSIST)
ndash Be a good listenerndash Minimal intervention in absence of time for more
intensive interventionbull ARRANGE follow-up
ndash Use the referral process if needed
38
Tobacco Quitlinesbull Toll-free national portal
ndash Links to state quitline by area code
bull Trained counselors providingndash information self-help materialsndash individual counselingndash local referralsndash may provide free cessation meds
bull Effectiveness well demonstrated bull Reach ~1 of smokers annually
39
Internet Interventionsbull Increasing sophistication + interactionbull Best Practices Individual tailoring
bull Smokefreegovndash Evidence-based tailored to readiness to quitndash Assistance via IM + phone (1-877-44U-QUIT)ndash SmokefreeTXT + Smokefree smartphone
bull Tailored versions for veterans women teens Spanish-speaking and older adults
bull Relative to quitlinesndash 27 Xs greater reach [annually 11 M vs 400K]ndash at a lower cost per quit [$291 vs $900]Smokefreegov
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
bull For US adults cigarettes are by far the most common form of tobacco
bull All forms of tobacco are harmful
bull The safetyefficacy of e-cigarettes is not established
bull E-cigarettes have increased in their efficiency of nicotine delivery
bull Clinical attention to all forms of tobacco is needed
10
US ADULT SMOKING by SEX 1955ndash2018
Graph provided by the Centers for Disease Control and Prevention 1955 Current Population Survey 1965ndash2018 NHIS Estimates since 1992 include some-day smoking
2017 NHIS US Adults Current Ecig Use by Race6 Multi-racial3 non-Hispanic White2 non-Hispanic Black2 Hispanic1 non-Hispanic Asian
14
Q True or False
A FalseNearly 70 of adults who smoke report wanting to quit
Most adults who smoke do not want to quit
15
Youth Tobacco Use Patterns NYTS 2019
bull 2019 Monitoring the Future study 1 in 9 HS seniors (117) vaped nicotine nearly daily bull NHIS 2018 32 of adults currently used e-cigs every day or some days
16
17
FDA Ecig Flavor Restrictionbull Prohibits the sale of flavored cartridge-based e-cigs
other than menthol or tobacco flavorbull As of Feb 6 2020 many flavored e-liquid pods
including Juul and Juul-compatible products are no longer sold legally in US
bull The guidance does notndash Restrict all flavors ndash Address concept flavorsndash Include all e-cigs (tanksmods closed systems)ndash Apply to other tobacco products (eg cigars
cigarillos hookah)
X X X XX
18SOURCE MAYO
19
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
20
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
21
What is Addiction
ldquoCompulsive drug use without medical purpose in the face of negative consequencesrdquo
bull Other cataract diabetes (type 2) erectile dysfunction impaired immune function osteoporosis periodontitis postoperative complications rheumatoid arthritis
US Department of Health and Human Services (USDHHS) (2014)The Health Consequences of Smokingmdash50 Years of Progress A Report of the Surgeon General
25
SMOKING EPIDEMIOLOGY amp HARMS
26
E-cig Aerosol may Containbull Nicotine (even if marketed as 0 nicotine)bull Ultrafine particles that can be inhaled deep into the lungsbull Flavoring such as diacetyl a chemical linked to a serious lung dzbull Volatile organic compounds (VOCs)bull Cancer-causing chemicalsbull Heavy metals such as nickel tin and lead
Primary humectants are propylene glycol and glycerol (aka vegetable glycerin)
At lower levels than in combusted tobacco smoke
27
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
elevated white blood cell countsndash Injuries resembled ldquoexposures to
toxic chemical fumes poisonous gases and toxic agentsrdquo (Mayo)
A diagnosis of exclusion
bull Patient Recommendationsndash Do not use THC-containing vaping
products particularly from informal sources (eg friends family in-person or online sellers)
ndash Vitamin E acetate should not be added to vaping products
Krishnasamy et al (2020) MMWR
28
Reporting EVALI Casesbull CDC encourages clinicians to
continue to report possible EVALI cases to their local or state health department for further investigation
bull If EVALI suspected collect a detailed history ofndash Substances used ndash Sources of products ndash Duration and frequency of usendash Devices used and how used
EVALI Confirmed Case Criteria
29
30
USE amp HARMS SUMMARY
bull Fewer than 1 in 7 US adults are current smokers
bull Smoking prevalence varies by sociodemographic characteristics
bull Nearly half a million US deaths are attributable to smoking annually
bull Smoking costs the US an estimated $300 billion annually
bull E-cigarettes are a diverse product group and their health harms are still being determined
31
OverviewEpidemiology nicotine product landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
32
Counseling7 in 10 tobacco users see a healthcare provider in a given year
Treating tobacco is relevant to all areas of medicine
USPSTF ldquoGrade Ardquo recommendation for clinician-delivered brief tobacco treatment
Counseling by nonphysician health providers also increases quit rates
33
National Cancer Institutersquos 5 As
ASK all patients about use of all forms of tobacco
1
ADVISEtobacco users to quit
2
ASSESS patient readiness to quit
3
ASSIST in the quit attempt with counseling medications amp referrals
ndash Intensive counseling only (without medications) more effective than minimal contact (ie brief advice + self-help materials)
ndash Greater effects when combined with cessation medications
37
COUNSELING SUMMARYbull Routinely identify tobacco users (ASK)bull Strongly ADVISE patients to quitbull ASSESS readiness to quit at each contactbull Tailor intervention messages (ASSIST)
ndash Be a good listenerndash Minimal intervention in absence of time for more
intensive interventionbull ARRANGE follow-up
ndash Use the referral process if needed
38
Tobacco Quitlinesbull Toll-free national portal
ndash Links to state quitline by area code
bull Trained counselors providingndash information self-help materialsndash individual counselingndash local referralsndash may provide free cessation meds
bull Effectiveness well demonstrated bull Reach ~1 of smokers annually
39
Internet Interventionsbull Increasing sophistication + interactionbull Best Practices Individual tailoring
bull Smokefreegovndash Evidence-based tailored to readiness to quitndash Assistance via IM + phone (1-877-44U-QUIT)ndash SmokefreeTXT + Smokefree smartphone
bull Tailored versions for veterans women teens Spanish-speaking and older adults
bull Relative to quitlinesndash 27 Xs greater reach [annually 11 M vs 400K]ndash at a lower cost per quit [$291 vs $900]Smokefreegov
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
bull For US adults cigarettes are by far the most common form of tobacco
bull All forms of tobacco are harmful
bull The safetyefficacy of e-cigarettes is not established
bull E-cigarettes have increased in their efficiency of nicotine delivery
bull Clinical attention to all forms of tobacco is needed
10
US ADULT SMOKING by SEX 1955ndash2018
Graph provided by the Centers for Disease Control and Prevention 1955 Current Population Survey 1965ndash2018 NHIS Estimates since 1992 include some-day smoking
2017 NHIS US Adults Current Ecig Use by Race6 Multi-racial3 non-Hispanic White2 non-Hispanic Black2 Hispanic1 non-Hispanic Asian
14
Q True or False
A FalseNearly 70 of adults who smoke report wanting to quit
Most adults who smoke do not want to quit
15
Youth Tobacco Use Patterns NYTS 2019
bull 2019 Monitoring the Future study 1 in 9 HS seniors (117) vaped nicotine nearly daily bull NHIS 2018 32 of adults currently used e-cigs every day or some days
16
17
FDA Ecig Flavor Restrictionbull Prohibits the sale of flavored cartridge-based e-cigs
other than menthol or tobacco flavorbull As of Feb 6 2020 many flavored e-liquid pods
including Juul and Juul-compatible products are no longer sold legally in US
bull The guidance does notndash Restrict all flavors ndash Address concept flavorsndash Include all e-cigs (tanksmods closed systems)ndash Apply to other tobacco products (eg cigars
cigarillos hookah)
X X X XX
18SOURCE MAYO
19
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
20
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
21
What is Addiction
ldquoCompulsive drug use without medical purpose in the face of negative consequencesrdquo
bull Other cataract diabetes (type 2) erectile dysfunction impaired immune function osteoporosis periodontitis postoperative complications rheumatoid arthritis
US Department of Health and Human Services (USDHHS) (2014)The Health Consequences of Smokingmdash50 Years of Progress A Report of the Surgeon General
25
SMOKING EPIDEMIOLOGY amp HARMS
26
E-cig Aerosol may Containbull Nicotine (even if marketed as 0 nicotine)bull Ultrafine particles that can be inhaled deep into the lungsbull Flavoring such as diacetyl a chemical linked to a serious lung dzbull Volatile organic compounds (VOCs)bull Cancer-causing chemicalsbull Heavy metals such as nickel tin and lead
Primary humectants are propylene glycol and glycerol (aka vegetable glycerin)
At lower levels than in combusted tobacco smoke
27
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
elevated white blood cell countsndash Injuries resembled ldquoexposures to
toxic chemical fumes poisonous gases and toxic agentsrdquo (Mayo)
A diagnosis of exclusion
bull Patient Recommendationsndash Do not use THC-containing vaping
products particularly from informal sources (eg friends family in-person or online sellers)
ndash Vitamin E acetate should not be added to vaping products
Krishnasamy et al (2020) MMWR
28
Reporting EVALI Casesbull CDC encourages clinicians to
continue to report possible EVALI cases to their local or state health department for further investigation
bull If EVALI suspected collect a detailed history ofndash Substances used ndash Sources of products ndash Duration and frequency of usendash Devices used and how used
EVALI Confirmed Case Criteria
29
30
USE amp HARMS SUMMARY
bull Fewer than 1 in 7 US adults are current smokers
bull Smoking prevalence varies by sociodemographic characteristics
bull Nearly half a million US deaths are attributable to smoking annually
bull Smoking costs the US an estimated $300 billion annually
bull E-cigarettes are a diverse product group and their health harms are still being determined
31
OverviewEpidemiology nicotine product landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
32
Counseling7 in 10 tobacco users see a healthcare provider in a given year
Treating tobacco is relevant to all areas of medicine
USPSTF ldquoGrade Ardquo recommendation for clinician-delivered brief tobacco treatment
Counseling by nonphysician health providers also increases quit rates
33
National Cancer Institutersquos 5 As
ASK all patients about use of all forms of tobacco
1
ADVISEtobacco users to quit
2
ASSESS patient readiness to quit
3
ASSIST in the quit attempt with counseling medications amp referrals
ndash Intensive counseling only (without medications) more effective than minimal contact (ie brief advice + self-help materials)
ndash Greater effects when combined with cessation medications
37
COUNSELING SUMMARYbull Routinely identify tobacco users (ASK)bull Strongly ADVISE patients to quitbull ASSESS readiness to quit at each contactbull Tailor intervention messages (ASSIST)
ndash Be a good listenerndash Minimal intervention in absence of time for more
intensive interventionbull ARRANGE follow-up
ndash Use the referral process if needed
38
Tobacco Quitlinesbull Toll-free national portal
ndash Links to state quitline by area code
bull Trained counselors providingndash information self-help materialsndash individual counselingndash local referralsndash may provide free cessation meds
bull Effectiveness well demonstrated bull Reach ~1 of smokers annually
39
Internet Interventionsbull Increasing sophistication + interactionbull Best Practices Individual tailoring
bull Smokefreegovndash Evidence-based tailored to readiness to quitndash Assistance via IM + phone (1-877-44U-QUIT)ndash SmokefreeTXT + Smokefree smartphone
bull Tailored versions for veterans women teens Spanish-speaking and older adults
bull Relative to quitlinesndash 27 Xs greater reach [annually 11 M vs 400K]ndash at a lower cost per quit [$291 vs $900]Smokefreegov
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
Varenicline
Bupropion
NRT
Placebo
Overall (N= 8058)
4
45
39
37
NPC (N = 3984)
13
22
25
24
PC (N = 4074)
65
67
52
49
To resize chart data range drag lower right corner of range
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
Varenicline
Bupropion
NRT
Placebo
Weeks 9ndash12
38
261
264
137
Weeks 9ndash24
255
188
185
105
Weeks 9ndash12
292
193
204
114
Weeks 9ndash24
183
137
13
83
Weeks 9ndash12
335
226
234
125
Weeks 9ndash24
218
162
157
94
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Men
Women
1955
542
245
1956
1957
1958
1959
1960
1961
1962
1963
1964
1965
519
339
1966
525
339
1967
1968
1969
1970
441
315
1971
1972
1973
1974
431
321
1975
1976
419
32
1977
409
321
1978
381
307
1979
375
299
1980
376
293
1981
1982
1983
351
295
1984
1985
326
279
1986
1987
312
265
1988
308
257
1989
1990
284
228
1991
281
235
1992
286
246
1993
277
225
1994
282
231
1995
27
226
1997
276
221
1998
264
22
1999
257
215
2000
257
21
2001
252
207
2002
252
20
2003
241
192
2004
234
185
2005
239
181
2006
239
18
2007
223
174
2008
231
183
2009
235
179
2010
215
173
2011
216
165
2012
205
158
2013
205
153
2014
188
148
2015
167
136
2016
175
135
2017
158
122
2018
156
12
1955
1955
1956
1956
1957
1957
1958
1958
1959
1959
1960
1960
1961
1961
1962
1962
1963
1963
1964
1964
1965
1965
1966
1966
1967
1967
1968
1968
1969
1969
1970
1970
1971
1971
1972
1972
1973
1973
1974
1974
1975
1975
1976
1976
1977
1977
1978
1978
1979
1979
1980
1980
1981
1981
1982
1982
1983
1983
1984
1984
1985
1985
1986
1986
1987
1987
1988
1988
1989
1989
1990
1990
1991
1991
1992
1992
1993
1993
1994
1994
1995
1995
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1997
1998
1998
1999
1999
2000
2000
2001
2001
2002
2002
2003
2003
2004
2004
2005
2005
2006
2006
2007
2007
2008
2008
2009
2009
2010
2010
2011
2011
2012
2012
2013
2013
2014
2014
2015
2015
2016
2016
2017
2017
2018
2018
8
E-CIGARETTE EVOLUTION
9
FORMS of TOBACCO SUMMARY
bull A variety of tobacco products exist
bull For US adults cigarettes are by far the most common form of tobacco
bull All forms of tobacco are harmful
bull The safetyefficacy of e-cigarettes is not established
bull E-cigarettes have increased in their efficiency of nicotine delivery
bull Clinical attention to all forms of tobacco is needed
10
US ADULT SMOKING by SEX 1955ndash2018
Graph provided by the Centers for Disease Control and Prevention 1955 Current Population Survey 1965ndash2018 NHIS Estimates since 1992 include some-day smoking
2017 NHIS US Adults Current Ecig Use by Race6 Multi-racial3 non-Hispanic White2 non-Hispanic Black2 Hispanic1 non-Hispanic Asian
14
Q True or False
A FalseNearly 70 of adults who smoke report wanting to quit
Most adults who smoke do not want to quit
15
Youth Tobacco Use Patterns NYTS 2019
bull 2019 Monitoring the Future study 1 in 9 HS seniors (117) vaped nicotine nearly daily bull NHIS 2018 32 of adults currently used e-cigs every day or some days
16
17
FDA Ecig Flavor Restrictionbull Prohibits the sale of flavored cartridge-based e-cigs
other than menthol or tobacco flavorbull As of Feb 6 2020 many flavored e-liquid pods
including Juul and Juul-compatible products are no longer sold legally in US
bull The guidance does notndash Restrict all flavors ndash Address concept flavorsndash Include all e-cigs (tanksmods closed systems)ndash Apply to other tobacco products (eg cigars
cigarillos hookah)
X X X XX
18SOURCE MAYO
19
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
20
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
21
What is Addiction
ldquoCompulsive drug use without medical purpose in the face of negative consequencesrdquo
bull Other cataract diabetes (type 2) erectile dysfunction impaired immune function osteoporosis periodontitis postoperative complications rheumatoid arthritis
US Department of Health and Human Services (USDHHS) (2014)The Health Consequences of Smokingmdash50 Years of Progress A Report of the Surgeon General
25
SMOKING EPIDEMIOLOGY amp HARMS
26
E-cig Aerosol may Containbull Nicotine (even if marketed as 0 nicotine)bull Ultrafine particles that can be inhaled deep into the lungsbull Flavoring such as diacetyl a chemical linked to a serious lung dzbull Volatile organic compounds (VOCs)bull Cancer-causing chemicalsbull Heavy metals such as nickel tin and lead
Primary humectants are propylene glycol and glycerol (aka vegetable glycerin)
At lower levels than in combusted tobacco smoke
27
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
elevated white blood cell countsndash Injuries resembled ldquoexposures to
toxic chemical fumes poisonous gases and toxic agentsrdquo (Mayo)
A diagnosis of exclusion
bull Patient Recommendationsndash Do not use THC-containing vaping
products particularly from informal sources (eg friends family in-person or online sellers)
ndash Vitamin E acetate should not be added to vaping products
Krishnasamy et al (2020) MMWR
28
Reporting EVALI Casesbull CDC encourages clinicians to
continue to report possible EVALI cases to their local or state health department for further investigation
bull If EVALI suspected collect a detailed history ofndash Substances used ndash Sources of products ndash Duration and frequency of usendash Devices used and how used
EVALI Confirmed Case Criteria
29
30
USE amp HARMS SUMMARY
bull Fewer than 1 in 7 US adults are current smokers
bull Smoking prevalence varies by sociodemographic characteristics
bull Nearly half a million US deaths are attributable to smoking annually
bull Smoking costs the US an estimated $300 billion annually
bull E-cigarettes are a diverse product group and their health harms are still being determined
31
OverviewEpidemiology nicotine product landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
32
Counseling7 in 10 tobacco users see a healthcare provider in a given year
Treating tobacco is relevant to all areas of medicine
USPSTF ldquoGrade Ardquo recommendation for clinician-delivered brief tobacco treatment
Counseling by nonphysician health providers also increases quit rates
33
National Cancer Institutersquos 5 As
ASK all patients about use of all forms of tobacco
1
ADVISEtobacco users to quit
2
ASSESS patient readiness to quit
3
ASSIST in the quit attempt with counseling medications amp referrals
ndash Intensive counseling only (without medications) more effective than minimal contact (ie brief advice + self-help materials)
ndash Greater effects when combined with cessation medications
37
COUNSELING SUMMARYbull Routinely identify tobacco users (ASK)bull Strongly ADVISE patients to quitbull ASSESS readiness to quit at each contactbull Tailor intervention messages (ASSIST)
ndash Be a good listenerndash Minimal intervention in absence of time for more
intensive interventionbull ARRANGE follow-up
ndash Use the referral process if needed
38
Tobacco Quitlinesbull Toll-free national portal
ndash Links to state quitline by area code
bull Trained counselors providingndash information self-help materialsndash individual counselingndash local referralsndash may provide free cessation meds
bull Effectiveness well demonstrated bull Reach ~1 of smokers annually
39
Internet Interventionsbull Increasing sophistication + interactionbull Best Practices Individual tailoring
bull Smokefreegovndash Evidence-based tailored to readiness to quitndash Assistance via IM + phone (1-877-44U-QUIT)ndash SmokefreeTXT + Smokefree smartphone
bull Tailored versions for veterans women teens Spanish-speaking and older adults
bull Relative to quitlinesndash 27 Xs greater reach [annually 11 M vs 400K]ndash at a lower cost per quit [$291 vs $900]Smokefreegov
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
Varenicline
Bupropion
NRT
Placebo
Overall (N= 8058)
4
45
39
37
NPC (N = 3984)
13
22
25
24
PC (N = 4074)
65
67
52
49
To resize chart data range drag lower right corner of range
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
Varenicline
Bupropion
NRT
Placebo
Weeks 9ndash12
38
261
264
137
Weeks 9ndash24
255
188
185
105
Weeks 9ndash12
292
193
204
114
Weeks 9ndash24
183
137
13
83
Weeks 9ndash12
335
226
234
125
Weeks 9ndash24
218
162
157
94
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Men
Women
1955
542
245
1956
1957
1958
1959
1960
1961
1962
1963
1964
1965
519
339
1966
525
339
1967
1968
1969
1970
441
315
1971
1972
1973
1974
431
321
1975
1976
419
32
1977
409
321
1978
381
307
1979
375
299
1980
376
293
1981
1982
1983
351
295
1984
1985
326
279
1986
1987
312
265
1988
308
257
1989
1990
284
228
1991
281
235
1992
286
246
1993
277
225
1994
282
231
1995
27
226
1997
276
221
1998
264
22
1999
257
215
2000
257
21
2001
252
207
2002
252
20
2003
241
192
2004
234
185
2005
239
181
2006
239
18
2007
223
174
2008
231
183
2009
235
179
2010
215
173
2011
216
165
2012
205
158
2013
205
153
2014
188
148
2015
167
136
2016
175
135
2017
158
122
2018
156
12
1955
1955
1956
1956
1957
1957
1958
1958
1959
1959
1960
1960
1961
1961
1962
1962
1963
1963
1964
1964
1965
1965
1966
1966
1967
1967
1968
1968
1969
1969
1970
1970
1971
1971
1972
1972
1973
1973
1974
1974
1975
1975
1976
1976
1977
1977
1978
1978
1979
1979
1980
1980
1981
1981
1982
1982
1983
1983
1984
1984
1985
1985
1986
1986
1987
1987
1988
1988
1989
1989
1990
1990
1991
1991
1992
1992
1993
1993
1994
1994
1995
1995
1997
1997
1998
1998
1999
1999
2000
2000
2001
2001
2002
2002
2003
2003
2004
2004
2005
2005
2006
2006
2007
2007
2008
2008
2009
2009
2010
2010
2011
2011
2012
2012
2013
2013
2014
2014
2015
2015
2016
2016
2017
2017
2018
2018
9
FORMS of TOBACCO SUMMARY
bull A variety of tobacco products exist
bull For US adults cigarettes are by far the most common form of tobacco
bull All forms of tobacco are harmful
bull The safetyefficacy of e-cigarettes is not established
bull E-cigarettes have increased in their efficiency of nicotine delivery
bull Clinical attention to all forms of tobacco is needed
10
US ADULT SMOKING by SEX 1955ndash2018
Graph provided by the Centers for Disease Control and Prevention 1955 Current Population Survey 1965ndash2018 NHIS Estimates since 1992 include some-day smoking
2017 NHIS US Adults Current Ecig Use by Race6 Multi-racial3 non-Hispanic White2 non-Hispanic Black2 Hispanic1 non-Hispanic Asian
14
Q True or False
A FalseNearly 70 of adults who smoke report wanting to quit
Most adults who smoke do not want to quit
15
Youth Tobacco Use Patterns NYTS 2019
bull 2019 Monitoring the Future study 1 in 9 HS seniors (117) vaped nicotine nearly daily bull NHIS 2018 32 of adults currently used e-cigs every day or some days
16
17
FDA Ecig Flavor Restrictionbull Prohibits the sale of flavored cartridge-based e-cigs
other than menthol or tobacco flavorbull As of Feb 6 2020 many flavored e-liquid pods
including Juul and Juul-compatible products are no longer sold legally in US
bull The guidance does notndash Restrict all flavors ndash Address concept flavorsndash Include all e-cigs (tanksmods closed systems)ndash Apply to other tobacco products (eg cigars
cigarillos hookah)
X X X XX
18SOURCE MAYO
19
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
20
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
21
What is Addiction
ldquoCompulsive drug use without medical purpose in the face of negative consequencesrdquo
bull Other cataract diabetes (type 2) erectile dysfunction impaired immune function osteoporosis periodontitis postoperative complications rheumatoid arthritis
US Department of Health and Human Services (USDHHS) (2014)The Health Consequences of Smokingmdash50 Years of Progress A Report of the Surgeon General
25
SMOKING EPIDEMIOLOGY amp HARMS
26
E-cig Aerosol may Containbull Nicotine (even if marketed as 0 nicotine)bull Ultrafine particles that can be inhaled deep into the lungsbull Flavoring such as diacetyl a chemical linked to a serious lung dzbull Volatile organic compounds (VOCs)bull Cancer-causing chemicalsbull Heavy metals such as nickel tin and lead
Primary humectants are propylene glycol and glycerol (aka vegetable glycerin)
At lower levels than in combusted tobacco smoke
27
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
elevated white blood cell countsndash Injuries resembled ldquoexposures to
toxic chemical fumes poisonous gases and toxic agentsrdquo (Mayo)
A diagnosis of exclusion
bull Patient Recommendationsndash Do not use THC-containing vaping
products particularly from informal sources (eg friends family in-person or online sellers)
ndash Vitamin E acetate should not be added to vaping products
Krishnasamy et al (2020) MMWR
28
Reporting EVALI Casesbull CDC encourages clinicians to
continue to report possible EVALI cases to their local or state health department for further investigation
bull If EVALI suspected collect a detailed history ofndash Substances used ndash Sources of products ndash Duration and frequency of usendash Devices used and how used
EVALI Confirmed Case Criteria
29
30
USE amp HARMS SUMMARY
bull Fewer than 1 in 7 US adults are current smokers
bull Smoking prevalence varies by sociodemographic characteristics
bull Nearly half a million US deaths are attributable to smoking annually
bull Smoking costs the US an estimated $300 billion annually
bull E-cigarettes are a diverse product group and their health harms are still being determined
31
OverviewEpidemiology nicotine product landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
32
Counseling7 in 10 tobacco users see a healthcare provider in a given year
Treating tobacco is relevant to all areas of medicine
USPSTF ldquoGrade Ardquo recommendation for clinician-delivered brief tobacco treatment
Counseling by nonphysician health providers also increases quit rates
33
National Cancer Institutersquos 5 As
ASK all patients about use of all forms of tobacco
1
ADVISEtobacco users to quit
2
ASSESS patient readiness to quit
3
ASSIST in the quit attempt with counseling medications amp referrals
ndash Intensive counseling only (without medications) more effective than minimal contact (ie brief advice + self-help materials)
ndash Greater effects when combined with cessation medications
37
COUNSELING SUMMARYbull Routinely identify tobacco users (ASK)bull Strongly ADVISE patients to quitbull ASSESS readiness to quit at each contactbull Tailor intervention messages (ASSIST)
ndash Be a good listenerndash Minimal intervention in absence of time for more
intensive interventionbull ARRANGE follow-up
ndash Use the referral process if needed
38
Tobacco Quitlinesbull Toll-free national portal
ndash Links to state quitline by area code
bull Trained counselors providingndash information self-help materialsndash individual counselingndash local referralsndash may provide free cessation meds
bull Effectiveness well demonstrated bull Reach ~1 of smokers annually
39
Internet Interventionsbull Increasing sophistication + interactionbull Best Practices Individual tailoring
bull Smokefreegovndash Evidence-based tailored to readiness to quitndash Assistance via IM + phone (1-877-44U-QUIT)ndash SmokefreeTXT + Smokefree smartphone
bull Tailored versions for veterans women teens Spanish-speaking and older adults
bull Relative to quitlinesndash 27 Xs greater reach [annually 11 M vs 400K]ndash at a lower cost per quit [$291 vs $900]Smokefreegov
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
Varenicline
Bupropion
NRT
Placebo
Overall (N= 8058)
4
45
39
37
NPC (N = 3984)
13
22
25
24
PC (N = 4074)
65
67
52
49
To resize chart data range drag lower right corner of range
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
Varenicline
Bupropion
NRT
Placebo
Weeks 9ndash12
38
261
264
137
Weeks 9ndash24
255
188
185
105
Weeks 9ndash12
292
193
204
114
Weeks 9ndash24
183
137
13
83
Weeks 9ndash12
335
226
234
125
Weeks 9ndash24
218
162
157
94
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Men
Women
1955
542
245
1956
1957
1958
1959
1960
1961
1962
1963
1964
1965
519
339
1966
525
339
1967
1968
1969
1970
441
315
1971
1972
1973
1974
431
321
1975
1976
419
32
1977
409
321
1978
381
307
1979
375
299
1980
376
293
1981
1982
1983
351
295
1984
1985
326
279
1986
1987
312
265
1988
308
257
1989
1990
284
228
1991
281
235
1992
286
246
1993
277
225
1994
282
231
1995
27
226
1997
276
221
1998
264
22
1999
257
215
2000
257
21
2001
252
207
2002
252
20
2003
241
192
2004
234
185
2005
239
181
2006
239
18
2007
223
174
2008
231
183
2009
235
179
2010
215
173
2011
216
165
2012
205
158
2013
205
153
2014
188
148
2015
167
136
2016
175
135
2017
158
122
2018
156
12
1955
1955
1956
1956
1957
1957
1958
1958
1959
1959
1960
1960
1961
1961
1962
1962
1963
1963
1964
1964
1965
1965
1966
1966
1967
1967
1968
1968
1969
1969
1970
1970
1971
1971
1972
1972
1973
1973
1974
1974
1975
1975
1976
1976
1977
1977
1978
1978
1979
1979
1980
1980
1981
1981
1982
1982
1983
1983
1984
1984
1985
1985
1986
1986
1987
1987
1988
1988
1989
1989
1990
1990
1991
1991
1992
1992
1993
1993
1994
1994
1995
1995
1997
1997
1998
1998
1999
1999
2000
2000
2001
2001
2002
2002
2003
2003
2004
2004
2005
2005
2006
2006
2007
2007
2008
2008
2009
2009
2010
2010
2011
2011
2012
2012
2013
2013
2014
2014
2015
2015
2016
2016
2017
2017
2018
2018
10
US ADULT SMOKING by SEX 1955ndash2018
Graph provided by the Centers for Disease Control and Prevention 1955 Current Population Survey 1965ndash2018 NHIS Estimates since 1992 include some-day smoking
2017 NHIS US Adults Current Ecig Use by Race6 Multi-racial3 non-Hispanic White2 non-Hispanic Black2 Hispanic1 non-Hispanic Asian
14
Q True or False
A FalseNearly 70 of adults who smoke report wanting to quit
Most adults who smoke do not want to quit
15
Youth Tobacco Use Patterns NYTS 2019
bull 2019 Monitoring the Future study 1 in 9 HS seniors (117) vaped nicotine nearly daily bull NHIS 2018 32 of adults currently used e-cigs every day or some days
16
17
FDA Ecig Flavor Restrictionbull Prohibits the sale of flavored cartridge-based e-cigs
other than menthol or tobacco flavorbull As of Feb 6 2020 many flavored e-liquid pods
including Juul and Juul-compatible products are no longer sold legally in US
bull The guidance does notndash Restrict all flavors ndash Address concept flavorsndash Include all e-cigs (tanksmods closed systems)ndash Apply to other tobacco products (eg cigars
cigarillos hookah)
X X X XX
18SOURCE MAYO
19
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
20
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
21
What is Addiction
ldquoCompulsive drug use without medical purpose in the face of negative consequencesrdquo
bull Other cataract diabetes (type 2) erectile dysfunction impaired immune function osteoporosis periodontitis postoperative complications rheumatoid arthritis
US Department of Health and Human Services (USDHHS) (2014)The Health Consequences of Smokingmdash50 Years of Progress A Report of the Surgeon General
25
SMOKING EPIDEMIOLOGY amp HARMS
26
E-cig Aerosol may Containbull Nicotine (even if marketed as 0 nicotine)bull Ultrafine particles that can be inhaled deep into the lungsbull Flavoring such as diacetyl a chemical linked to a serious lung dzbull Volatile organic compounds (VOCs)bull Cancer-causing chemicalsbull Heavy metals such as nickel tin and lead
Primary humectants are propylene glycol and glycerol (aka vegetable glycerin)
At lower levels than in combusted tobacco smoke
27
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
elevated white blood cell countsndash Injuries resembled ldquoexposures to
toxic chemical fumes poisonous gases and toxic agentsrdquo (Mayo)
A diagnosis of exclusion
bull Patient Recommendationsndash Do not use THC-containing vaping
products particularly from informal sources (eg friends family in-person or online sellers)
ndash Vitamin E acetate should not be added to vaping products
Krishnasamy et al (2020) MMWR
28
Reporting EVALI Casesbull CDC encourages clinicians to
continue to report possible EVALI cases to their local or state health department for further investigation
bull If EVALI suspected collect a detailed history ofndash Substances used ndash Sources of products ndash Duration and frequency of usendash Devices used and how used
EVALI Confirmed Case Criteria
29
30
USE amp HARMS SUMMARY
bull Fewer than 1 in 7 US adults are current smokers
bull Smoking prevalence varies by sociodemographic characteristics
bull Nearly half a million US deaths are attributable to smoking annually
bull Smoking costs the US an estimated $300 billion annually
bull E-cigarettes are a diverse product group and their health harms are still being determined
31
OverviewEpidemiology nicotine product landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
32
Counseling7 in 10 tobacco users see a healthcare provider in a given year
Treating tobacco is relevant to all areas of medicine
USPSTF ldquoGrade Ardquo recommendation for clinician-delivered brief tobacco treatment
Counseling by nonphysician health providers also increases quit rates
33
National Cancer Institutersquos 5 As
ASK all patients about use of all forms of tobacco
1
ADVISEtobacco users to quit
2
ASSESS patient readiness to quit
3
ASSIST in the quit attempt with counseling medications amp referrals
ndash Intensive counseling only (without medications) more effective than minimal contact (ie brief advice + self-help materials)
ndash Greater effects when combined with cessation medications
37
COUNSELING SUMMARYbull Routinely identify tobacco users (ASK)bull Strongly ADVISE patients to quitbull ASSESS readiness to quit at each contactbull Tailor intervention messages (ASSIST)
ndash Be a good listenerndash Minimal intervention in absence of time for more
intensive interventionbull ARRANGE follow-up
ndash Use the referral process if needed
38
Tobacco Quitlinesbull Toll-free national portal
ndash Links to state quitline by area code
bull Trained counselors providingndash information self-help materialsndash individual counselingndash local referralsndash may provide free cessation meds
bull Effectiveness well demonstrated bull Reach ~1 of smokers annually
39
Internet Interventionsbull Increasing sophistication + interactionbull Best Practices Individual tailoring
bull Smokefreegovndash Evidence-based tailored to readiness to quitndash Assistance via IM + phone (1-877-44U-QUIT)ndash SmokefreeTXT + Smokefree smartphone
bull Tailored versions for veterans women teens Spanish-speaking and older adults
bull Relative to quitlinesndash 27 Xs greater reach [annually 11 M vs 400K]ndash at a lower cost per quit [$291 vs $900]Smokefreegov
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
Varenicline
Bupropion
NRT
Placebo
Overall (N= 8058)
4
45
39
37
NPC (N = 3984)
13
22
25
24
PC (N = 4074)
65
67
52
49
To resize chart data range drag lower right corner of range
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
Varenicline
Bupropion
NRT
Placebo
Weeks 9ndash12
38
261
264
137
Weeks 9ndash24
255
188
185
105
Weeks 9ndash12
292
193
204
114
Weeks 9ndash24
183
137
13
83
Weeks 9ndash12
335
226
234
125
Weeks 9ndash24
218
162
157
94
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Men
Women
1955
542
245
1956
1957
1958
1959
1960
1961
1962
1963
1964
1965
519
339
1966
525
339
1967
1968
1969
1970
441
315
1971
1972
1973
1974
431
321
1975
1976
419
32
1977
409
321
1978
381
307
1979
375
299
1980
376
293
1981
1982
1983
351
295
1984
1985
326
279
1986
1987
312
265
1988
308
257
1989
1990
284
228
1991
281
235
1992
286
246
1993
277
225
1994
282
231
1995
27
226
1997
276
221
1998
264
22
1999
257
215
2000
257
21
2001
252
207
2002
252
20
2003
241
192
2004
234
185
2005
239
181
2006
239
18
2007
223
174
2008
231
183
2009
235
179
2010
215
173
2011
216
165
2012
205
158
2013
205
153
2014
188
148
2015
167
136
2016
175
135
2017
158
122
2018
156
12
1955
1955
1956
1956
1957
1957
1958
1958
1959
1959
1960
1960
1961
1961
1962
1962
1963
1963
1964
1964
1965
1965
1966
1966
1967
1967
1968
1968
1969
1969
1970
1970
1971
1971
1972
1972
1973
1973
1974
1974
1975
1975
1976
1976
1977
1977
1978
1978
1979
1979
1980
1980
1981
1981
1982
1982
1983
1983
1984
1984
1985
1985
1986
1986
1987
1987
1988
1988
1989
1989
1990
1990
1991
1991
1992
1992
1993
1993
1994
1994
1995
1995
1997
1997
1998
1998
1999
1999
2000
2000
2001
2001
2002
2002
2003
2003
2004
2004
2005
2005
2006
2006
2007
2007
2008
2008
2009
2009
2010
2010
2011
2011
2012
2012
2013
2013
2014
2014
2015
2015
2016
2016
2017
2017
2018
2018
Chart1
Men
Women
542
245
519
339
525
339
441
315
431
321
419
32
409
321
381
307
375
299
376
293
351
295
326
279
312
265
308
257
284
228
281
235
286
246
277
225
282
231
27
226
276
221
264
22
257
215
257
21
252
207
252
20
241
192
234
185
239
181
239
18
223
174
231
183
235
179
215
173
216
165
205
158
205
153
188
148
167
136
175
135
158
122
156
12
Sheet1
11
CIGARETTE SMOKING PREVALENCE BY CENSUS TRACK
Source CDC RWJF
WASHINGTON DC
12
Nearly 7 in 10 adults who smoke want to quit
13
2017 NHIS US Adults Current Ecig Use by Race6 Multi-racial3 non-Hispanic White2 non-Hispanic Black2 Hispanic1 non-Hispanic Asian
14
Q True or False
A FalseNearly 70 of adults who smoke report wanting to quit
Most adults who smoke do not want to quit
15
Youth Tobacco Use Patterns NYTS 2019
bull 2019 Monitoring the Future study 1 in 9 HS seniors (117) vaped nicotine nearly daily bull NHIS 2018 32 of adults currently used e-cigs every day or some days
16
17
FDA Ecig Flavor Restrictionbull Prohibits the sale of flavored cartridge-based e-cigs
other than menthol or tobacco flavorbull As of Feb 6 2020 many flavored e-liquid pods
including Juul and Juul-compatible products are no longer sold legally in US
bull The guidance does notndash Restrict all flavors ndash Address concept flavorsndash Include all e-cigs (tanksmods closed systems)ndash Apply to other tobacco products (eg cigars
cigarillos hookah)
X X X XX
18SOURCE MAYO
19
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
20
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
21
What is Addiction
ldquoCompulsive drug use without medical purpose in the face of negative consequencesrdquo
bull Other cataract diabetes (type 2) erectile dysfunction impaired immune function osteoporosis periodontitis postoperative complications rheumatoid arthritis
US Department of Health and Human Services (USDHHS) (2014)The Health Consequences of Smokingmdash50 Years of Progress A Report of the Surgeon General
25
SMOKING EPIDEMIOLOGY amp HARMS
26
E-cig Aerosol may Containbull Nicotine (even if marketed as 0 nicotine)bull Ultrafine particles that can be inhaled deep into the lungsbull Flavoring such as diacetyl a chemical linked to a serious lung dzbull Volatile organic compounds (VOCs)bull Cancer-causing chemicalsbull Heavy metals such as nickel tin and lead
Primary humectants are propylene glycol and glycerol (aka vegetable glycerin)
At lower levels than in combusted tobacco smoke
27
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
elevated white blood cell countsndash Injuries resembled ldquoexposures to
toxic chemical fumes poisonous gases and toxic agentsrdquo (Mayo)
A diagnosis of exclusion
bull Patient Recommendationsndash Do not use THC-containing vaping
products particularly from informal sources (eg friends family in-person or online sellers)
ndash Vitamin E acetate should not be added to vaping products
Krishnasamy et al (2020) MMWR
28
Reporting EVALI Casesbull CDC encourages clinicians to
continue to report possible EVALI cases to their local or state health department for further investigation
bull If EVALI suspected collect a detailed history ofndash Substances used ndash Sources of products ndash Duration and frequency of usendash Devices used and how used
EVALI Confirmed Case Criteria
29
30
USE amp HARMS SUMMARY
bull Fewer than 1 in 7 US adults are current smokers
bull Smoking prevalence varies by sociodemographic characteristics
bull Nearly half a million US deaths are attributable to smoking annually
bull Smoking costs the US an estimated $300 billion annually
bull E-cigarettes are a diverse product group and their health harms are still being determined
31
OverviewEpidemiology nicotine product landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
32
Counseling7 in 10 tobacco users see a healthcare provider in a given year
Treating tobacco is relevant to all areas of medicine
USPSTF ldquoGrade Ardquo recommendation for clinician-delivered brief tobacco treatment
Counseling by nonphysician health providers also increases quit rates
33
National Cancer Institutersquos 5 As
ASK all patients about use of all forms of tobacco
1
ADVISEtobacco users to quit
2
ASSESS patient readiness to quit
3
ASSIST in the quit attempt with counseling medications amp referrals
ndash Intensive counseling only (without medications) more effective than minimal contact (ie brief advice + self-help materials)
ndash Greater effects when combined with cessation medications
37
COUNSELING SUMMARYbull Routinely identify tobacco users (ASK)bull Strongly ADVISE patients to quitbull ASSESS readiness to quit at each contactbull Tailor intervention messages (ASSIST)
ndash Be a good listenerndash Minimal intervention in absence of time for more
intensive interventionbull ARRANGE follow-up
ndash Use the referral process if needed
38
Tobacco Quitlinesbull Toll-free national portal
ndash Links to state quitline by area code
bull Trained counselors providingndash information self-help materialsndash individual counselingndash local referralsndash may provide free cessation meds
bull Effectiveness well demonstrated bull Reach ~1 of smokers annually
39
Internet Interventionsbull Increasing sophistication + interactionbull Best Practices Individual tailoring
bull Smokefreegovndash Evidence-based tailored to readiness to quitndash Assistance via IM + phone (1-877-44U-QUIT)ndash SmokefreeTXT + Smokefree smartphone
bull Tailored versions for veterans women teens Spanish-speaking and older adults
bull Relative to quitlinesndash 27 Xs greater reach [annually 11 M vs 400K]ndash at a lower cost per quit [$291 vs $900]Smokefreegov
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
Varenicline
Bupropion
NRT
Placebo
Overall (N= 8058)
4
45
39
37
NPC (N = 3984)
13
22
25
24
PC (N = 4074)
65
67
52
49
To resize chart data range drag lower right corner of range
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
Varenicline
Bupropion
NRT
Placebo
Weeks 9ndash12
38
261
264
137
Weeks 9ndash24
255
188
185
105
Weeks 9ndash12
292
193
204
114
Weeks 9ndash24
183
137
13
83
Weeks 9ndash12
335
226
234
125
Weeks 9ndash24
218
162
157
94
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Men
Women
1955
542
245
1956
1957
1958
1959
1960
1961
1962
1963
1964
1965
519
339
1966
525
339
1967
1968
1969
1970
441
315
1971
1972
1973
1974
431
321
1975
1976
419
32
1977
409
321
1978
381
307
1979
375
299
1980
376
293
1981
1982
1983
351
295
1984
1985
326
279
1986
1987
312
265
1988
308
257
1989
1990
284
228
1991
281
235
1992
286
246
1993
277
225
1994
282
231
1995
27
226
1997
276
221
1998
264
22
1999
257
215
2000
257
21
2001
252
207
2002
252
20
2003
241
192
2004
234
185
2005
239
181
2006
239
18
2007
223
174
2008
231
183
2009
235
179
2010
215
173
2011
216
165
2012
205
158
2013
205
153
2014
188
148
2015
167
136
2016
175
135
2017
158
122
2018
156
12
1955
1955
1956
1956
1957
1957
1958
1958
1959
1959
1960
1960
1961
1961
1962
1962
1963
1963
1964
1964
1965
1965
1966
1966
1967
1967
1968
1968
1969
1969
1970
1970
1971
1971
1972
1972
1973
1973
1974
1974
1975
1975
1976
1976
1977
1977
1978
1978
1979
1979
1980
1980
1981
1981
1982
1982
1983
1983
1984
1984
1985
1985
1986
1986
1987
1987
1988
1988
1989
1989
1990
1990
1991
1991
1992
1992
1993
1993
1994
1994
1995
1995
1997
1997
1998
1998
1999
1999
2000
2000
2001
2001
2002
2002
2003
2003
2004
2004
2005
2005
2006
2006
2007
2007
2008
2008
2009
2009
2010
2010
2011
2011
2012
2012
2013
2013
2014
2014
2015
2015
2016
2016
2017
2017
2018
2018
Sheet1
11
CIGARETTE SMOKING PREVALENCE BY CENSUS TRACK
Source CDC RWJF
WASHINGTON DC
12
Nearly 7 in 10 adults who smoke want to quit
13
2017 NHIS US Adults Current Ecig Use by Race6 Multi-racial3 non-Hispanic White2 non-Hispanic Black2 Hispanic1 non-Hispanic Asian
14
Q True or False
A FalseNearly 70 of adults who smoke report wanting to quit
Most adults who smoke do not want to quit
15
Youth Tobacco Use Patterns NYTS 2019
bull 2019 Monitoring the Future study 1 in 9 HS seniors (117) vaped nicotine nearly daily bull NHIS 2018 32 of adults currently used e-cigs every day or some days
16
17
FDA Ecig Flavor Restrictionbull Prohibits the sale of flavored cartridge-based e-cigs
other than menthol or tobacco flavorbull As of Feb 6 2020 many flavored e-liquid pods
including Juul and Juul-compatible products are no longer sold legally in US
bull The guidance does notndash Restrict all flavors ndash Address concept flavorsndash Include all e-cigs (tanksmods closed systems)ndash Apply to other tobacco products (eg cigars
cigarillos hookah)
X X X XX
18SOURCE MAYO
19
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
20
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
21
What is Addiction
ldquoCompulsive drug use without medical purpose in the face of negative consequencesrdquo
bull Other cataract diabetes (type 2) erectile dysfunction impaired immune function osteoporosis periodontitis postoperative complications rheumatoid arthritis
US Department of Health and Human Services (USDHHS) (2014)The Health Consequences of Smokingmdash50 Years of Progress A Report of the Surgeon General
25
SMOKING EPIDEMIOLOGY amp HARMS
26
E-cig Aerosol may Containbull Nicotine (even if marketed as 0 nicotine)bull Ultrafine particles that can be inhaled deep into the lungsbull Flavoring such as diacetyl a chemical linked to a serious lung dzbull Volatile organic compounds (VOCs)bull Cancer-causing chemicalsbull Heavy metals such as nickel tin and lead
Primary humectants are propylene glycol and glycerol (aka vegetable glycerin)
At lower levels than in combusted tobacco smoke
27
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
elevated white blood cell countsndash Injuries resembled ldquoexposures to
toxic chemical fumes poisonous gases and toxic agentsrdquo (Mayo)
A diagnosis of exclusion
bull Patient Recommendationsndash Do not use THC-containing vaping
products particularly from informal sources (eg friends family in-person or online sellers)
ndash Vitamin E acetate should not be added to vaping products
Krishnasamy et al (2020) MMWR
28
Reporting EVALI Casesbull CDC encourages clinicians to
continue to report possible EVALI cases to their local or state health department for further investigation
bull If EVALI suspected collect a detailed history ofndash Substances used ndash Sources of products ndash Duration and frequency of usendash Devices used and how used
EVALI Confirmed Case Criteria
29
30
USE amp HARMS SUMMARY
bull Fewer than 1 in 7 US adults are current smokers
bull Smoking prevalence varies by sociodemographic characteristics
bull Nearly half a million US deaths are attributable to smoking annually
bull Smoking costs the US an estimated $300 billion annually
bull E-cigarettes are a diverse product group and their health harms are still being determined
31
OverviewEpidemiology nicotine product landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
32
Counseling7 in 10 tobacco users see a healthcare provider in a given year
Treating tobacco is relevant to all areas of medicine
USPSTF ldquoGrade Ardquo recommendation for clinician-delivered brief tobacco treatment
Counseling by nonphysician health providers also increases quit rates
33
National Cancer Institutersquos 5 As
ASK all patients about use of all forms of tobacco
1
ADVISEtobacco users to quit
2
ASSESS patient readiness to quit
3
ASSIST in the quit attempt with counseling medications amp referrals
ndash Intensive counseling only (without medications) more effective than minimal contact (ie brief advice + self-help materials)
ndash Greater effects when combined with cessation medications
37
COUNSELING SUMMARYbull Routinely identify tobacco users (ASK)bull Strongly ADVISE patients to quitbull ASSESS readiness to quit at each contactbull Tailor intervention messages (ASSIST)
ndash Be a good listenerndash Minimal intervention in absence of time for more
intensive interventionbull ARRANGE follow-up
ndash Use the referral process if needed
38
Tobacco Quitlinesbull Toll-free national portal
ndash Links to state quitline by area code
bull Trained counselors providingndash information self-help materialsndash individual counselingndash local referralsndash may provide free cessation meds
bull Effectiveness well demonstrated bull Reach ~1 of smokers annually
39
Internet Interventionsbull Increasing sophistication + interactionbull Best Practices Individual tailoring
bull Smokefreegovndash Evidence-based tailored to readiness to quitndash Assistance via IM + phone (1-877-44U-QUIT)ndash SmokefreeTXT + Smokefree smartphone
bull Tailored versions for veterans women teens Spanish-speaking and older adults
bull Relative to quitlinesndash 27 Xs greater reach [annually 11 M vs 400K]ndash at a lower cost per quit [$291 vs $900]Smokefreegov
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
Varenicline
Bupropion
NRT
Placebo
Overall (N= 8058)
4
45
39
37
NPC (N = 3984)
13
22
25
24
PC (N = 4074)
65
67
52
49
To resize chart data range drag lower right corner of range
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
Varenicline
Bupropion
NRT
Placebo
Weeks 9ndash12
38
261
264
137
Weeks 9ndash24
255
188
185
105
Weeks 9ndash12
292
193
204
114
Weeks 9ndash24
183
137
13
83
Weeks 9ndash12
335
226
234
125
Weeks 9ndash24
218
162
157
94
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Men
Women
1955
542
245
1956
1957
1958
1959
1960
1961
1962
1963
1964
1965
519
339
1966
525
339
1967
1968
1969
1970
441
315
1971
1972
1973
1974
431
321
1975
1976
419
32
1977
409
321
1978
381
307
1979
375
299
1980
376
293
1981
1982
1983
351
295
1984
1985
326
279
1986
1987
312
265
1988
308
257
1989
1990
284
228
1991
281
235
1992
286
246
1993
277
225
1994
282
231
1995
27
226
1997
276
221
1998
264
22
1999
257
215
2000
257
21
2001
252
207
2002
252
20
2003
241
192
2004
234
185
2005
239
181
2006
239
18
2007
223
174
2008
231
183
2009
235
179
2010
215
173
2011
216
165
2012
205
158
2013
205
153
2014
188
148
2015
167
136
2016
175
135
2017
158
122
2018
156
12
11
CIGARETTE SMOKING PREVALENCE BY CENSUS TRACK
Source CDC RWJF
WASHINGTON DC
12
Nearly 7 in 10 adults who smoke want to quit
13
2017 NHIS US Adults Current Ecig Use by Race6 Multi-racial3 non-Hispanic White2 non-Hispanic Black2 Hispanic1 non-Hispanic Asian
14
Q True or False
A FalseNearly 70 of adults who smoke report wanting to quit
Most adults who smoke do not want to quit
15
Youth Tobacco Use Patterns NYTS 2019
bull 2019 Monitoring the Future study 1 in 9 HS seniors (117) vaped nicotine nearly daily bull NHIS 2018 32 of adults currently used e-cigs every day or some days
16
17
FDA Ecig Flavor Restrictionbull Prohibits the sale of flavored cartridge-based e-cigs
other than menthol or tobacco flavorbull As of Feb 6 2020 many flavored e-liquid pods
including Juul and Juul-compatible products are no longer sold legally in US
bull The guidance does notndash Restrict all flavors ndash Address concept flavorsndash Include all e-cigs (tanksmods closed systems)ndash Apply to other tobacco products (eg cigars
cigarillos hookah)
X X X XX
18SOURCE MAYO
19
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
20
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
21
What is Addiction
ldquoCompulsive drug use without medical purpose in the face of negative consequencesrdquo
bull Other cataract diabetes (type 2) erectile dysfunction impaired immune function osteoporosis periodontitis postoperative complications rheumatoid arthritis
US Department of Health and Human Services (USDHHS) (2014)The Health Consequences of Smokingmdash50 Years of Progress A Report of the Surgeon General
25
SMOKING EPIDEMIOLOGY amp HARMS
26
E-cig Aerosol may Containbull Nicotine (even if marketed as 0 nicotine)bull Ultrafine particles that can be inhaled deep into the lungsbull Flavoring such as diacetyl a chemical linked to a serious lung dzbull Volatile organic compounds (VOCs)bull Cancer-causing chemicalsbull Heavy metals such as nickel tin and lead
Primary humectants are propylene glycol and glycerol (aka vegetable glycerin)
At lower levels than in combusted tobacco smoke
27
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
elevated white blood cell countsndash Injuries resembled ldquoexposures to
toxic chemical fumes poisonous gases and toxic agentsrdquo (Mayo)
A diagnosis of exclusion
bull Patient Recommendationsndash Do not use THC-containing vaping
products particularly from informal sources (eg friends family in-person or online sellers)
ndash Vitamin E acetate should not be added to vaping products
Krishnasamy et al (2020) MMWR
28
Reporting EVALI Casesbull CDC encourages clinicians to
continue to report possible EVALI cases to their local or state health department for further investigation
bull If EVALI suspected collect a detailed history ofndash Substances used ndash Sources of products ndash Duration and frequency of usendash Devices used and how used
EVALI Confirmed Case Criteria
29
30
USE amp HARMS SUMMARY
bull Fewer than 1 in 7 US adults are current smokers
bull Smoking prevalence varies by sociodemographic characteristics
bull Nearly half a million US deaths are attributable to smoking annually
bull Smoking costs the US an estimated $300 billion annually
bull E-cigarettes are a diverse product group and their health harms are still being determined
31
OverviewEpidemiology nicotine product landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
32
Counseling7 in 10 tobacco users see a healthcare provider in a given year
Treating tobacco is relevant to all areas of medicine
USPSTF ldquoGrade Ardquo recommendation for clinician-delivered brief tobacco treatment
Counseling by nonphysician health providers also increases quit rates
33
National Cancer Institutersquos 5 As
ASK all patients about use of all forms of tobacco
1
ADVISEtobacco users to quit
2
ASSESS patient readiness to quit
3
ASSIST in the quit attempt with counseling medications amp referrals
ndash Intensive counseling only (without medications) more effective than minimal contact (ie brief advice + self-help materials)
ndash Greater effects when combined with cessation medications
37
COUNSELING SUMMARYbull Routinely identify tobacco users (ASK)bull Strongly ADVISE patients to quitbull ASSESS readiness to quit at each contactbull Tailor intervention messages (ASSIST)
ndash Be a good listenerndash Minimal intervention in absence of time for more
intensive interventionbull ARRANGE follow-up
ndash Use the referral process if needed
38
Tobacco Quitlinesbull Toll-free national portal
ndash Links to state quitline by area code
bull Trained counselors providingndash information self-help materialsndash individual counselingndash local referralsndash may provide free cessation meds
bull Effectiveness well demonstrated bull Reach ~1 of smokers annually
39
Internet Interventionsbull Increasing sophistication + interactionbull Best Practices Individual tailoring
bull Smokefreegovndash Evidence-based tailored to readiness to quitndash Assistance via IM + phone (1-877-44U-QUIT)ndash SmokefreeTXT + Smokefree smartphone
bull Tailored versions for veterans women teens Spanish-speaking and older adults
bull Relative to quitlinesndash 27 Xs greater reach [annually 11 M vs 400K]ndash at a lower cost per quit [$291 vs $900]Smokefreegov
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
Varenicline
Bupropion
NRT
Placebo
Overall (N= 8058)
4
45
39
37
NPC (N = 3984)
13
22
25
24
PC (N = 4074)
65
67
52
49
To resize chart data range drag lower right corner of range
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
Varenicline
Bupropion
NRT
Placebo
Weeks 9ndash12
38
261
264
137
Weeks 9ndash24
255
188
185
105
Weeks 9ndash12
292
193
204
114
Weeks 9ndash24
183
137
13
83
Weeks 9ndash12
335
226
234
125
Weeks 9ndash24
218
162
157
94
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
12
Nearly 7 in 10 adults who smoke want to quit
13
2017 NHIS US Adults Current Ecig Use by Race6 Multi-racial3 non-Hispanic White2 non-Hispanic Black2 Hispanic1 non-Hispanic Asian
14
Q True or False
A FalseNearly 70 of adults who smoke report wanting to quit
Most adults who smoke do not want to quit
15
Youth Tobacco Use Patterns NYTS 2019
bull 2019 Monitoring the Future study 1 in 9 HS seniors (117) vaped nicotine nearly daily bull NHIS 2018 32 of adults currently used e-cigs every day or some days
16
17
FDA Ecig Flavor Restrictionbull Prohibits the sale of flavored cartridge-based e-cigs
other than menthol or tobacco flavorbull As of Feb 6 2020 many flavored e-liquid pods
including Juul and Juul-compatible products are no longer sold legally in US
bull The guidance does notndash Restrict all flavors ndash Address concept flavorsndash Include all e-cigs (tanksmods closed systems)ndash Apply to other tobacco products (eg cigars
cigarillos hookah)
X X X XX
18SOURCE MAYO
19
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
20
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
21
What is Addiction
ldquoCompulsive drug use without medical purpose in the face of negative consequencesrdquo
bull Other cataract diabetes (type 2) erectile dysfunction impaired immune function osteoporosis periodontitis postoperative complications rheumatoid arthritis
US Department of Health and Human Services (USDHHS) (2014)The Health Consequences of Smokingmdash50 Years of Progress A Report of the Surgeon General
25
SMOKING EPIDEMIOLOGY amp HARMS
26
E-cig Aerosol may Containbull Nicotine (even if marketed as 0 nicotine)bull Ultrafine particles that can be inhaled deep into the lungsbull Flavoring such as diacetyl a chemical linked to a serious lung dzbull Volatile organic compounds (VOCs)bull Cancer-causing chemicalsbull Heavy metals such as nickel tin and lead
Primary humectants are propylene glycol and glycerol (aka vegetable glycerin)
At lower levels than in combusted tobacco smoke
27
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
elevated white blood cell countsndash Injuries resembled ldquoexposures to
toxic chemical fumes poisonous gases and toxic agentsrdquo (Mayo)
A diagnosis of exclusion
bull Patient Recommendationsndash Do not use THC-containing vaping
products particularly from informal sources (eg friends family in-person or online sellers)
ndash Vitamin E acetate should not be added to vaping products
Krishnasamy et al (2020) MMWR
28
Reporting EVALI Casesbull CDC encourages clinicians to
continue to report possible EVALI cases to their local or state health department for further investigation
bull If EVALI suspected collect a detailed history ofndash Substances used ndash Sources of products ndash Duration and frequency of usendash Devices used and how used
EVALI Confirmed Case Criteria
29
30
USE amp HARMS SUMMARY
bull Fewer than 1 in 7 US adults are current smokers
bull Smoking prevalence varies by sociodemographic characteristics
bull Nearly half a million US deaths are attributable to smoking annually
bull Smoking costs the US an estimated $300 billion annually
bull E-cigarettes are a diverse product group and their health harms are still being determined
31
OverviewEpidemiology nicotine product landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
32
Counseling7 in 10 tobacco users see a healthcare provider in a given year
Treating tobacco is relevant to all areas of medicine
USPSTF ldquoGrade Ardquo recommendation for clinician-delivered brief tobacco treatment
Counseling by nonphysician health providers also increases quit rates
33
National Cancer Institutersquos 5 As
ASK all patients about use of all forms of tobacco
1
ADVISEtobacco users to quit
2
ASSESS patient readiness to quit
3
ASSIST in the quit attempt with counseling medications amp referrals
ndash Intensive counseling only (without medications) more effective than minimal contact (ie brief advice + self-help materials)
ndash Greater effects when combined with cessation medications
37
COUNSELING SUMMARYbull Routinely identify tobacco users (ASK)bull Strongly ADVISE patients to quitbull ASSESS readiness to quit at each contactbull Tailor intervention messages (ASSIST)
ndash Be a good listenerndash Minimal intervention in absence of time for more
intensive interventionbull ARRANGE follow-up
ndash Use the referral process if needed
38
Tobacco Quitlinesbull Toll-free national portal
ndash Links to state quitline by area code
bull Trained counselors providingndash information self-help materialsndash individual counselingndash local referralsndash may provide free cessation meds
bull Effectiveness well demonstrated bull Reach ~1 of smokers annually
39
Internet Interventionsbull Increasing sophistication + interactionbull Best Practices Individual tailoring
bull Smokefreegovndash Evidence-based tailored to readiness to quitndash Assistance via IM + phone (1-877-44U-QUIT)ndash SmokefreeTXT + Smokefree smartphone
bull Tailored versions for veterans women teens Spanish-speaking and older adults
bull Relative to quitlinesndash 27 Xs greater reach [annually 11 M vs 400K]ndash at a lower cost per quit [$291 vs $900]Smokefreegov
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
Varenicline
Bupropion
NRT
Placebo
Overall (N= 8058)
4
45
39
37
NPC (N = 3984)
13
22
25
24
PC (N = 4074)
65
67
52
49
To resize chart data range drag lower right corner of range
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
Varenicline
Bupropion
NRT
Placebo
Weeks 9ndash12
38
261
264
137
Weeks 9ndash24
255
188
185
105
Weeks 9ndash12
292
193
204
114
Weeks 9ndash24
183
137
13
83
Weeks 9ndash12
335
226
234
125
Weeks 9ndash24
218
162
157
94
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
13
2017 NHIS US Adults Current Ecig Use by Race6 Multi-racial3 non-Hispanic White2 non-Hispanic Black2 Hispanic1 non-Hispanic Asian
14
Q True or False
A FalseNearly 70 of adults who smoke report wanting to quit
Most adults who smoke do not want to quit
15
Youth Tobacco Use Patterns NYTS 2019
bull 2019 Monitoring the Future study 1 in 9 HS seniors (117) vaped nicotine nearly daily bull NHIS 2018 32 of adults currently used e-cigs every day or some days
16
17
FDA Ecig Flavor Restrictionbull Prohibits the sale of flavored cartridge-based e-cigs
other than menthol or tobacco flavorbull As of Feb 6 2020 many flavored e-liquid pods
including Juul and Juul-compatible products are no longer sold legally in US
bull The guidance does notndash Restrict all flavors ndash Address concept flavorsndash Include all e-cigs (tanksmods closed systems)ndash Apply to other tobacco products (eg cigars
cigarillos hookah)
X X X XX
18SOURCE MAYO
19
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
20
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
21
What is Addiction
ldquoCompulsive drug use without medical purpose in the face of negative consequencesrdquo
bull Other cataract diabetes (type 2) erectile dysfunction impaired immune function osteoporosis periodontitis postoperative complications rheumatoid arthritis
US Department of Health and Human Services (USDHHS) (2014)The Health Consequences of Smokingmdash50 Years of Progress A Report of the Surgeon General
25
SMOKING EPIDEMIOLOGY amp HARMS
26
E-cig Aerosol may Containbull Nicotine (even if marketed as 0 nicotine)bull Ultrafine particles that can be inhaled deep into the lungsbull Flavoring such as diacetyl a chemical linked to a serious lung dzbull Volatile organic compounds (VOCs)bull Cancer-causing chemicalsbull Heavy metals such as nickel tin and lead
Primary humectants are propylene glycol and glycerol (aka vegetable glycerin)
At lower levels than in combusted tobacco smoke
27
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
elevated white blood cell countsndash Injuries resembled ldquoexposures to
toxic chemical fumes poisonous gases and toxic agentsrdquo (Mayo)
A diagnosis of exclusion
bull Patient Recommendationsndash Do not use THC-containing vaping
products particularly from informal sources (eg friends family in-person or online sellers)
ndash Vitamin E acetate should not be added to vaping products
Krishnasamy et al (2020) MMWR
28
Reporting EVALI Casesbull CDC encourages clinicians to
continue to report possible EVALI cases to their local or state health department for further investigation
bull If EVALI suspected collect a detailed history ofndash Substances used ndash Sources of products ndash Duration and frequency of usendash Devices used and how used
EVALI Confirmed Case Criteria
29
30
USE amp HARMS SUMMARY
bull Fewer than 1 in 7 US adults are current smokers
bull Smoking prevalence varies by sociodemographic characteristics
bull Nearly half a million US deaths are attributable to smoking annually
bull Smoking costs the US an estimated $300 billion annually
bull E-cigarettes are a diverse product group and their health harms are still being determined
31
OverviewEpidemiology nicotine product landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
32
Counseling7 in 10 tobacco users see a healthcare provider in a given year
Treating tobacco is relevant to all areas of medicine
USPSTF ldquoGrade Ardquo recommendation for clinician-delivered brief tobacco treatment
Counseling by nonphysician health providers also increases quit rates
33
National Cancer Institutersquos 5 As
ASK all patients about use of all forms of tobacco
1
ADVISEtobacco users to quit
2
ASSESS patient readiness to quit
3
ASSIST in the quit attempt with counseling medications amp referrals
ndash Intensive counseling only (without medications) more effective than minimal contact (ie brief advice + self-help materials)
ndash Greater effects when combined with cessation medications
37
COUNSELING SUMMARYbull Routinely identify tobacco users (ASK)bull Strongly ADVISE patients to quitbull ASSESS readiness to quit at each contactbull Tailor intervention messages (ASSIST)
ndash Be a good listenerndash Minimal intervention in absence of time for more
intensive interventionbull ARRANGE follow-up
ndash Use the referral process if needed
38
Tobacco Quitlinesbull Toll-free national portal
ndash Links to state quitline by area code
bull Trained counselors providingndash information self-help materialsndash individual counselingndash local referralsndash may provide free cessation meds
bull Effectiveness well demonstrated bull Reach ~1 of smokers annually
39
Internet Interventionsbull Increasing sophistication + interactionbull Best Practices Individual tailoring
bull Smokefreegovndash Evidence-based tailored to readiness to quitndash Assistance via IM + phone (1-877-44U-QUIT)ndash SmokefreeTXT + Smokefree smartphone
bull Tailored versions for veterans women teens Spanish-speaking and older adults
bull Relative to quitlinesndash 27 Xs greater reach [annually 11 M vs 400K]ndash at a lower cost per quit [$291 vs $900]Smokefreegov
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
Varenicline
Bupropion
NRT
Placebo
Overall (N= 8058)
4
45
39
37
NPC (N = 3984)
13
22
25
24
PC (N = 4074)
65
67
52
49
To resize chart data range drag lower right corner of range
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
Varenicline
Bupropion
NRT
Placebo
Weeks 9ndash12
38
261
264
137
Weeks 9ndash24
255
188
185
105
Weeks 9ndash12
292
193
204
114
Weeks 9ndash24
183
137
13
83
Weeks 9ndash12
335
226
234
125
Weeks 9ndash24
218
162
157
94
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
14
Q True or False
A FalseNearly 70 of adults who smoke report wanting to quit
Most adults who smoke do not want to quit
15
Youth Tobacco Use Patterns NYTS 2019
bull 2019 Monitoring the Future study 1 in 9 HS seniors (117) vaped nicotine nearly daily bull NHIS 2018 32 of adults currently used e-cigs every day or some days
16
17
FDA Ecig Flavor Restrictionbull Prohibits the sale of flavored cartridge-based e-cigs
other than menthol or tobacco flavorbull As of Feb 6 2020 many flavored e-liquid pods
including Juul and Juul-compatible products are no longer sold legally in US
bull The guidance does notndash Restrict all flavors ndash Address concept flavorsndash Include all e-cigs (tanksmods closed systems)ndash Apply to other tobacco products (eg cigars
cigarillos hookah)
X X X XX
18SOURCE MAYO
19
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
20
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
21
What is Addiction
ldquoCompulsive drug use without medical purpose in the face of negative consequencesrdquo
bull Other cataract diabetes (type 2) erectile dysfunction impaired immune function osteoporosis periodontitis postoperative complications rheumatoid arthritis
US Department of Health and Human Services (USDHHS) (2014)The Health Consequences of Smokingmdash50 Years of Progress A Report of the Surgeon General
25
SMOKING EPIDEMIOLOGY amp HARMS
26
E-cig Aerosol may Containbull Nicotine (even if marketed as 0 nicotine)bull Ultrafine particles that can be inhaled deep into the lungsbull Flavoring such as diacetyl a chemical linked to a serious lung dzbull Volatile organic compounds (VOCs)bull Cancer-causing chemicalsbull Heavy metals such as nickel tin and lead
Primary humectants are propylene glycol and glycerol (aka vegetable glycerin)
At lower levels than in combusted tobacco smoke
27
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
elevated white blood cell countsndash Injuries resembled ldquoexposures to
toxic chemical fumes poisonous gases and toxic agentsrdquo (Mayo)
A diagnosis of exclusion
bull Patient Recommendationsndash Do not use THC-containing vaping
products particularly from informal sources (eg friends family in-person or online sellers)
ndash Vitamin E acetate should not be added to vaping products
Krishnasamy et al (2020) MMWR
28
Reporting EVALI Casesbull CDC encourages clinicians to
continue to report possible EVALI cases to their local or state health department for further investigation
bull If EVALI suspected collect a detailed history ofndash Substances used ndash Sources of products ndash Duration and frequency of usendash Devices used and how used
EVALI Confirmed Case Criteria
29
30
USE amp HARMS SUMMARY
bull Fewer than 1 in 7 US adults are current smokers
bull Smoking prevalence varies by sociodemographic characteristics
bull Nearly half a million US deaths are attributable to smoking annually
bull Smoking costs the US an estimated $300 billion annually
bull E-cigarettes are a diverse product group and their health harms are still being determined
31
OverviewEpidemiology nicotine product landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
32
Counseling7 in 10 tobacco users see a healthcare provider in a given year
Treating tobacco is relevant to all areas of medicine
USPSTF ldquoGrade Ardquo recommendation for clinician-delivered brief tobacco treatment
Counseling by nonphysician health providers also increases quit rates
33
National Cancer Institutersquos 5 As
ASK all patients about use of all forms of tobacco
1
ADVISEtobacco users to quit
2
ASSESS patient readiness to quit
3
ASSIST in the quit attempt with counseling medications amp referrals
ndash Intensive counseling only (without medications) more effective than minimal contact (ie brief advice + self-help materials)
ndash Greater effects when combined with cessation medications
37
COUNSELING SUMMARYbull Routinely identify tobacco users (ASK)bull Strongly ADVISE patients to quitbull ASSESS readiness to quit at each contactbull Tailor intervention messages (ASSIST)
ndash Be a good listenerndash Minimal intervention in absence of time for more
intensive interventionbull ARRANGE follow-up
ndash Use the referral process if needed
38
Tobacco Quitlinesbull Toll-free national portal
ndash Links to state quitline by area code
bull Trained counselors providingndash information self-help materialsndash individual counselingndash local referralsndash may provide free cessation meds
bull Effectiveness well demonstrated bull Reach ~1 of smokers annually
39
Internet Interventionsbull Increasing sophistication + interactionbull Best Practices Individual tailoring
bull Smokefreegovndash Evidence-based tailored to readiness to quitndash Assistance via IM + phone (1-877-44U-QUIT)ndash SmokefreeTXT + Smokefree smartphone
bull Tailored versions for veterans women teens Spanish-speaking and older adults
bull Relative to quitlinesndash 27 Xs greater reach [annually 11 M vs 400K]ndash at a lower cost per quit [$291 vs $900]Smokefreegov
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
Varenicline
Bupropion
NRT
Placebo
Overall (N= 8058)
4
45
39
37
NPC (N = 3984)
13
22
25
24
PC (N = 4074)
65
67
52
49
To resize chart data range drag lower right corner of range
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
Varenicline
Bupropion
NRT
Placebo
Weeks 9ndash12
38
261
264
137
Weeks 9ndash24
255
188
185
105
Weeks 9ndash12
292
193
204
114
Weeks 9ndash24
183
137
13
83
Weeks 9ndash12
335
226
234
125
Weeks 9ndash24
218
162
157
94
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
15
Youth Tobacco Use Patterns NYTS 2019
bull 2019 Monitoring the Future study 1 in 9 HS seniors (117) vaped nicotine nearly daily bull NHIS 2018 32 of adults currently used e-cigs every day or some days
16
17
FDA Ecig Flavor Restrictionbull Prohibits the sale of flavored cartridge-based e-cigs
other than menthol or tobacco flavorbull As of Feb 6 2020 many flavored e-liquid pods
including Juul and Juul-compatible products are no longer sold legally in US
bull The guidance does notndash Restrict all flavors ndash Address concept flavorsndash Include all e-cigs (tanksmods closed systems)ndash Apply to other tobacco products (eg cigars
cigarillos hookah)
X X X XX
18SOURCE MAYO
19
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
20
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
21
What is Addiction
ldquoCompulsive drug use without medical purpose in the face of negative consequencesrdquo
bull Other cataract diabetes (type 2) erectile dysfunction impaired immune function osteoporosis periodontitis postoperative complications rheumatoid arthritis
US Department of Health and Human Services (USDHHS) (2014)The Health Consequences of Smokingmdash50 Years of Progress A Report of the Surgeon General
25
SMOKING EPIDEMIOLOGY amp HARMS
26
E-cig Aerosol may Containbull Nicotine (even if marketed as 0 nicotine)bull Ultrafine particles that can be inhaled deep into the lungsbull Flavoring such as diacetyl a chemical linked to a serious lung dzbull Volatile organic compounds (VOCs)bull Cancer-causing chemicalsbull Heavy metals such as nickel tin and lead
Primary humectants are propylene glycol and glycerol (aka vegetable glycerin)
At lower levels than in combusted tobacco smoke
27
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
elevated white blood cell countsndash Injuries resembled ldquoexposures to
toxic chemical fumes poisonous gases and toxic agentsrdquo (Mayo)
A diagnosis of exclusion
bull Patient Recommendationsndash Do not use THC-containing vaping
products particularly from informal sources (eg friends family in-person or online sellers)
ndash Vitamin E acetate should not be added to vaping products
Krishnasamy et al (2020) MMWR
28
Reporting EVALI Casesbull CDC encourages clinicians to
continue to report possible EVALI cases to their local or state health department for further investigation
bull If EVALI suspected collect a detailed history ofndash Substances used ndash Sources of products ndash Duration and frequency of usendash Devices used and how used
EVALI Confirmed Case Criteria
29
30
USE amp HARMS SUMMARY
bull Fewer than 1 in 7 US adults are current smokers
bull Smoking prevalence varies by sociodemographic characteristics
bull Nearly half a million US deaths are attributable to smoking annually
bull Smoking costs the US an estimated $300 billion annually
bull E-cigarettes are a diverse product group and their health harms are still being determined
31
OverviewEpidemiology nicotine product landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
32
Counseling7 in 10 tobacco users see a healthcare provider in a given year
Treating tobacco is relevant to all areas of medicine
USPSTF ldquoGrade Ardquo recommendation for clinician-delivered brief tobacco treatment
Counseling by nonphysician health providers also increases quit rates
33
National Cancer Institutersquos 5 As
ASK all patients about use of all forms of tobacco
1
ADVISEtobacco users to quit
2
ASSESS patient readiness to quit
3
ASSIST in the quit attempt with counseling medications amp referrals
ndash Intensive counseling only (without medications) more effective than minimal contact (ie brief advice + self-help materials)
ndash Greater effects when combined with cessation medications
37
COUNSELING SUMMARYbull Routinely identify tobacco users (ASK)bull Strongly ADVISE patients to quitbull ASSESS readiness to quit at each contactbull Tailor intervention messages (ASSIST)
ndash Be a good listenerndash Minimal intervention in absence of time for more
intensive interventionbull ARRANGE follow-up
ndash Use the referral process if needed
38
Tobacco Quitlinesbull Toll-free national portal
ndash Links to state quitline by area code
bull Trained counselors providingndash information self-help materialsndash individual counselingndash local referralsndash may provide free cessation meds
bull Effectiveness well demonstrated bull Reach ~1 of smokers annually
39
Internet Interventionsbull Increasing sophistication + interactionbull Best Practices Individual tailoring
bull Smokefreegovndash Evidence-based tailored to readiness to quitndash Assistance via IM + phone (1-877-44U-QUIT)ndash SmokefreeTXT + Smokefree smartphone
bull Tailored versions for veterans women teens Spanish-speaking and older adults
bull Relative to quitlinesndash 27 Xs greater reach [annually 11 M vs 400K]ndash at a lower cost per quit [$291 vs $900]Smokefreegov
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
Varenicline
Bupropion
NRT
Placebo
Overall (N= 8058)
4
45
39
37
NPC (N = 3984)
13
22
25
24
PC (N = 4074)
65
67
52
49
To resize chart data range drag lower right corner of range
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
Varenicline
Bupropion
NRT
Placebo
Weeks 9ndash12
38
261
264
137
Weeks 9ndash24
255
188
185
105
Weeks 9ndash12
292
193
204
114
Weeks 9ndash24
183
137
13
83
Weeks 9ndash12
335
226
234
125
Weeks 9ndash24
218
162
157
94
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
16
17
FDA Ecig Flavor Restrictionbull Prohibits the sale of flavored cartridge-based e-cigs
other than menthol or tobacco flavorbull As of Feb 6 2020 many flavored e-liquid pods
including Juul and Juul-compatible products are no longer sold legally in US
bull The guidance does notndash Restrict all flavors ndash Address concept flavorsndash Include all e-cigs (tanksmods closed systems)ndash Apply to other tobacco products (eg cigars
cigarillos hookah)
X X X XX
18SOURCE MAYO
19
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
20
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
21
What is Addiction
ldquoCompulsive drug use without medical purpose in the face of negative consequencesrdquo
bull Other cataract diabetes (type 2) erectile dysfunction impaired immune function osteoporosis periodontitis postoperative complications rheumatoid arthritis
US Department of Health and Human Services (USDHHS) (2014)The Health Consequences of Smokingmdash50 Years of Progress A Report of the Surgeon General
25
SMOKING EPIDEMIOLOGY amp HARMS
26
E-cig Aerosol may Containbull Nicotine (even if marketed as 0 nicotine)bull Ultrafine particles that can be inhaled deep into the lungsbull Flavoring such as diacetyl a chemical linked to a serious lung dzbull Volatile organic compounds (VOCs)bull Cancer-causing chemicalsbull Heavy metals such as nickel tin and lead
Primary humectants are propylene glycol and glycerol (aka vegetable glycerin)
At lower levels than in combusted tobacco smoke
27
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
elevated white blood cell countsndash Injuries resembled ldquoexposures to
toxic chemical fumes poisonous gases and toxic agentsrdquo (Mayo)
A diagnosis of exclusion
bull Patient Recommendationsndash Do not use THC-containing vaping
products particularly from informal sources (eg friends family in-person or online sellers)
ndash Vitamin E acetate should not be added to vaping products
Krishnasamy et al (2020) MMWR
28
Reporting EVALI Casesbull CDC encourages clinicians to
continue to report possible EVALI cases to their local or state health department for further investigation
bull If EVALI suspected collect a detailed history ofndash Substances used ndash Sources of products ndash Duration and frequency of usendash Devices used and how used
EVALI Confirmed Case Criteria
29
30
USE amp HARMS SUMMARY
bull Fewer than 1 in 7 US adults are current smokers
bull Smoking prevalence varies by sociodemographic characteristics
bull Nearly half a million US deaths are attributable to smoking annually
bull Smoking costs the US an estimated $300 billion annually
bull E-cigarettes are a diverse product group and their health harms are still being determined
31
OverviewEpidemiology nicotine product landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
32
Counseling7 in 10 tobacco users see a healthcare provider in a given year
Treating tobacco is relevant to all areas of medicine
USPSTF ldquoGrade Ardquo recommendation for clinician-delivered brief tobacco treatment
Counseling by nonphysician health providers also increases quit rates
33
National Cancer Institutersquos 5 As
ASK all patients about use of all forms of tobacco
1
ADVISEtobacco users to quit
2
ASSESS patient readiness to quit
3
ASSIST in the quit attempt with counseling medications amp referrals
ndash Intensive counseling only (without medications) more effective than minimal contact (ie brief advice + self-help materials)
ndash Greater effects when combined with cessation medications
37
COUNSELING SUMMARYbull Routinely identify tobacco users (ASK)bull Strongly ADVISE patients to quitbull ASSESS readiness to quit at each contactbull Tailor intervention messages (ASSIST)
ndash Be a good listenerndash Minimal intervention in absence of time for more
intensive interventionbull ARRANGE follow-up
ndash Use the referral process if needed
38
Tobacco Quitlinesbull Toll-free national portal
ndash Links to state quitline by area code
bull Trained counselors providingndash information self-help materialsndash individual counselingndash local referralsndash may provide free cessation meds
bull Effectiveness well demonstrated bull Reach ~1 of smokers annually
39
Internet Interventionsbull Increasing sophistication + interactionbull Best Practices Individual tailoring
bull Smokefreegovndash Evidence-based tailored to readiness to quitndash Assistance via IM + phone (1-877-44U-QUIT)ndash SmokefreeTXT + Smokefree smartphone
bull Tailored versions for veterans women teens Spanish-speaking and older adults
bull Relative to quitlinesndash 27 Xs greater reach [annually 11 M vs 400K]ndash at a lower cost per quit [$291 vs $900]Smokefreegov
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
Varenicline
Bupropion
NRT
Placebo
Overall (N= 8058)
4
45
39
37
NPC (N = 3984)
13
22
25
24
PC (N = 4074)
65
67
52
49
To resize chart data range drag lower right corner of range
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
Varenicline
Bupropion
NRT
Placebo
Weeks 9ndash12
38
261
264
137
Weeks 9ndash24
255
188
185
105
Weeks 9ndash12
292
193
204
114
Weeks 9ndash24
183
137
13
83
Weeks 9ndash12
335
226
234
125
Weeks 9ndash24
218
162
157
94
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
17
FDA Ecig Flavor Restrictionbull Prohibits the sale of flavored cartridge-based e-cigs
other than menthol or tobacco flavorbull As of Feb 6 2020 many flavored e-liquid pods
including Juul and Juul-compatible products are no longer sold legally in US
bull The guidance does notndash Restrict all flavors ndash Address concept flavorsndash Include all e-cigs (tanksmods closed systems)ndash Apply to other tobacco products (eg cigars
cigarillos hookah)
X X X XX
18SOURCE MAYO
19
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
20
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
21
What is Addiction
ldquoCompulsive drug use without medical purpose in the face of negative consequencesrdquo
bull Other cataract diabetes (type 2) erectile dysfunction impaired immune function osteoporosis periodontitis postoperative complications rheumatoid arthritis
US Department of Health and Human Services (USDHHS) (2014)The Health Consequences of Smokingmdash50 Years of Progress A Report of the Surgeon General
25
SMOKING EPIDEMIOLOGY amp HARMS
26
E-cig Aerosol may Containbull Nicotine (even if marketed as 0 nicotine)bull Ultrafine particles that can be inhaled deep into the lungsbull Flavoring such as diacetyl a chemical linked to a serious lung dzbull Volatile organic compounds (VOCs)bull Cancer-causing chemicalsbull Heavy metals such as nickel tin and lead
Primary humectants are propylene glycol and glycerol (aka vegetable glycerin)
At lower levels than in combusted tobacco smoke
27
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
elevated white blood cell countsndash Injuries resembled ldquoexposures to
toxic chemical fumes poisonous gases and toxic agentsrdquo (Mayo)
A diagnosis of exclusion
bull Patient Recommendationsndash Do not use THC-containing vaping
products particularly from informal sources (eg friends family in-person or online sellers)
ndash Vitamin E acetate should not be added to vaping products
Krishnasamy et al (2020) MMWR
28
Reporting EVALI Casesbull CDC encourages clinicians to
continue to report possible EVALI cases to their local or state health department for further investigation
bull If EVALI suspected collect a detailed history ofndash Substances used ndash Sources of products ndash Duration and frequency of usendash Devices used and how used
EVALI Confirmed Case Criteria
29
30
USE amp HARMS SUMMARY
bull Fewer than 1 in 7 US adults are current smokers
bull Smoking prevalence varies by sociodemographic characteristics
bull Nearly half a million US deaths are attributable to smoking annually
bull Smoking costs the US an estimated $300 billion annually
bull E-cigarettes are a diverse product group and their health harms are still being determined
31
OverviewEpidemiology nicotine product landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
32
Counseling7 in 10 tobacco users see a healthcare provider in a given year
Treating tobacco is relevant to all areas of medicine
USPSTF ldquoGrade Ardquo recommendation for clinician-delivered brief tobacco treatment
Counseling by nonphysician health providers also increases quit rates
33
National Cancer Institutersquos 5 As
ASK all patients about use of all forms of tobacco
1
ADVISEtobacco users to quit
2
ASSESS patient readiness to quit
3
ASSIST in the quit attempt with counseling medications amp referrals
ndash Intensive counseling only (without medications) more effective than minimal contact (ie brief advice + self-help materials)
ndash Greater effects when combined with cessation medications
37
COUNSELING SUMMARYbull Routinely identify tobacco users (ASK)bull Strongly ADVISE patients to quitbull ASSESS readiness to quit at each contactbull Tailor intervention messages (ASSIST)
ndash Be a good listenerndash Minimal intervention in absence of time for more
intensive interventionbull ARRANGE follow-up
ndash Use the referral process if needed
38
Tobacco Quitlinesbull Toll-free national portal
ndash Links to state quitline by area code
bull Trained counselors providingndash information self-help materialsndash individual counselingndash local referralsndash may provide free cessation meds
bull Effectiveness well demonstrated bull Reach ~1 of smokers annually
39
Internet Interventionsbull Increasing sophistication + interactionbull Best Practices Individual tailoring
bull Smokefreegovndash Evidence-based tailored to readiness to quitndash Assistance via IM + phone (1-877-44U-QUIT)ndash SmokefreeTXT + Smokefree smartphone
bull Tailored versions for veterans women teens Spanish-speaking and older adults
bull Relative to quitlinesndash 27 Xs greater reach [annually 11 M vs 400K]ndash at a lower cost per quit [$291 vs $900]Smokefreegov
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
Varenicline
Bupropion
NRT
Placebo
Overall (N= 8058)
4
45
39
37
NPC (N = 3984)
13
22
25
24
PC (N = 4074)
65
67
52
49
To resize chart data range drag lower right corner of range
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
Varenicline
Bupropion
NRT
Placebo
Weeks 9ndash12
38
261
264
137
Weeks 9ndash24
255
188
185
105
Weeks 9ndash12
292
193
204
114
Weeks 9ndash24
183
137
13
83
Weeks 9ndash12
335
226
234
125
Weeks 9ndash24
218
162
157
94
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
18SOURCE MAYO
19
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
20
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
21
What is Addiction
ldquoCompulsive drug use without medical purpose in the face of negative consequencesrdquo
bull Other cataract diabetes (type 2) erectile dysfunction impaired immune function osteoporosis periodontitis postoperative complications rheumatoid arthritis
US Department of Health and Human Services (USDHHS) (2014)The Health Consequences of Smokingmdash50 Years of Progress A Report of the Surgeon General
25
SMOKING EPIDEMIOLOGY amp HARMS
26
E-cig Aerosol may Containbull Nicotine (even if marketed as 0 nicotine)bull Ultrafine particles that can be inhaled deep into the lungsbull Flavoring such as diacetyl a chemical linked to a serious lung dzbull Volatile organic compounds (VOCs)bull Cancer-causing chemicalsbull Heavy metals such as nickel tin and lead
Primary humectants are propylene glycol and glycerol (aka vegetable glycerin)
At lower levels than in combusted tobacco smoke
27
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
elevated white blood cell countsndash Injuries resembled ldquoexposures to
toxic chemical fumes poisonous gases and toxic agentsrdquo (Mayo)
A diagnosis of exclusion
bull Patient Recommendationsndash Do not use THC-containing vaping
products particularly from informal sources (eg friends family in-person or online sellers)
ndash Vitamin E acetate should not be added to vaping products
Krishnasamy et al (2020) MMWR
28
Reporting EVALI Casesbull CDC encourages clinicians to
continue to report possible EVALI cases to their local or state health department for further investigation
bull If EVALI suspected collect a detailed history ofndash Substances used ndash Sources of products ndash Duration and frequency of usendash Devices used and how used
EVALI Confirmed Case Criteria
29
30
USE amp HARMS SUMMARY
bull Fewer than 1 in 7 US adults are current smokers
bull Smoking prevalence varies by sociodemographic characteristics
bull Nearly half a million US deaths are attributable to smoking annually
bull Smoking costs the US an estimated $300 billion annually
bull E-cigarettes are a diverse product group and their health harms are still being determined
31
OverviewEpidemiology nicotine product landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
32
Counseling7 in 10 tobacco users see a healthcare provider in a given year
Treating tobacco is relevant to all areas of medicine
USPSTF ldquoGrade Ardquo recommendation for clinician-delivered brief tobacco treatment
Counseling by nonphysician health providers also increases quit rates
33
National Cancer Institutersquos 5 As
ASK all patients about use of all forms of tobacco
1
ADVISEtobacco users to quit
2
ASSESS patient readiness to quit
3
ASSIST in the quit attempt with counseling medications amp referrals
ndash Intensive counseling only (without medications) more effective than minimal contact (ie brief advice + self-help materials)
ndash Greater effects when combined with cessation medications
37
COUNSELING SUMMARYbull Routinely identify tobacco users (ASK)bull Strongly ADVISE patients to quitbull ASSESS readiness to quit at each contactbull Tailor intervention messages (ASSIST)
ndash Be a good listenerndash Minimal intervention in absence of time for more
intensive interventionbull ARRANGE follow-up
ndash Use the referral process if needed
38
Tobacco Quitlinesbull Toll-free national portal
ndash Links to state quitline by area code
bull Trained counselors providingndash information self-help materialsndash individual counselingndash local referralsndash may provide free cessation meds
bull Effectiveness well demonstrated bull Reach ~1 of smokers annually
39
Internet Interventionsbull Increasing sophistication + interactionbull Best Practices Individual tailoring
bull Smokefreegovndash Evidence-based tailored to readiness to quitndash Assistance via IM + phone (1-877-44U-QUIT)ndash SmokefreeTXT + Smokefree smartphone
bull Tailored versions for veterans women teens Spanish-speaking and older adults
bull Relative to quitlinesndash 27 Xs greater reach [annually 11 M vs 400K]ndash at a lower cost per quit [$291 vs $900]Smokefreegov
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
Varenicline
Bupropion
NRT
Placebo
Overall (N= 8058)
4
45
39
37
NPC (N = 3984)
13
22
25
24
PC (N = 4074)
65
67
52
49
To resize chart data range drag lower right corner of range
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
Varenicline
Bupropion
NRT
Placebo
Weeks 9ndash12
38
261
264
137
Weeks 9ndash24
255
188
185
105
Weeks 9ndash12
292
193
204
114
Weeks 9ndash24
183
137
13
83
Weeks 9ndash12
335
226
234
125
Weeks 9ndash24
218
162
157
94
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
19
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
20
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
21
What is Addiction
ldquoCompulsive drug use without medical purpose in the face of negative consequencesrdquo
bull Other cataract diabetes (type 2) erectile dysfunction impaired immune function osteoporosis periodontitis postoperative complications rheumatoid arthritis
US Department of Health and Human Services (USDHHS) (2014)The Health Consequences of Smokingmdash50 Years of Progress A Report of the Surgeon General
25
SMOKING EPIDEMIOLOGY amp HARMS
26
E-cig Aerosol may Containbull Nicotine (even if marketed as 0 nicotine)bull Ultrafine particles that can be inhaled deep into the lungsbull Flavoring such as diacetyl a chemical linked to a serious lung dzbull Volatile organic compounds (VOCs)bull Cancer-causing chemicalsbull Heavy metals such as nickel tin and lead
Primary humectants are propylene glycol and glycerol (aka vegetable glycerin)
At lower levels than in combusted tobacco smoke
27
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
elevated white blood cell countsndash Injuries resembled ldquoexposures to
toxic chemical fumes poisonous gases and toxic agentsrdquo (Mayo)
A diagnosis of exclusion
bull Patient Recommendationsndash Do not use THC-containing vaping
products particularly from informal sources (eg friends family in-person or online sellers)
ndash Vitamin E acetate should not be added to vaping products
Krishnasamy et al (2020) MMWR
28
Reporting EVALI Casesbull CDC encourages clinicians to
continue to report possible EVALI cases to their local or state health department for further investigation
bull If EVALI suspected collect a detailed history ofndash Substances used ndash Sources of products ndash Duration and frequency of usendash Devices used and how used
EVALI Confirmed Case Criteria
29
30
USE amp HARMS SUMMARY
bull Fewer than 1 in 7 US adults are current smokers
bull Smoking prevalence varies by sociodemographic characteristics
bull Nearly half a million US deaths are attributable to smoking annually
bull Smoking costs the US an estimated $300 billion annually
bull E-cigarettes are a diverse product group and their health harms are still being determined
31
OverviewEpidemiology nicotine product landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
32
Counseling7 in 10 tobacco users see a healthcare provider in a given year
Treating tobacco is relevant to all areas of medicine
USPSTF ldquoGrade Ardquo recommendation for clinician-delivered brief tobacco treatment
Counseling by nonphysician health providers also increases quit rates
33
National Cancer Institutersquos 5 As
ASK all patients about use of all forms of tobacco
1
ADVISEtobacco users to quit
2
ASSESS patient readiness to quit
3
ASSIST in the quit attempt with counseling medications amp referrals
ndash Intensive counseling only (without medications) more effective than minimal contact (ie brief advice + self-help materials)
ndash Greater effects when combined with cessation medications
37
COUNSELING SUMMARYbull Routinely identify tobacco users (ASK)bull Strongly ADVISE patients to quitbull ASSESS readiness to quit at each contactbull Tailor intervention messages (ASSIST)
ndash Be a good listenerndash Minimal intervention in absence of time for more
intensive interventionbull ARRANGE follow-up
ndash Use the referral process if needed
38
Tobacco Quitlinesbull Toll-free national portal
ndash Links to state quitline by area code
bull Trained counselors providingndash information self-help materialsndash individual counselingndash local referralsndash may provide free cessation meds
bull Effectiveness well demonstrated bull Reach ~1 of smokers annually
39
Internet Interventionsbull Increasing sophistication + interactionbull Best Practices Individual tailoring
bull Smokefreegovndash Evidence-based tailored to readiness to quitndash Assistance via IM + phone (1-877-44U-QUIT)ndash SmokefreeTXT + Smokefree smartphone
bull Tailored versions for veterans women teens Spanish-speaking and older adults
bull Relative to quitlinesndash 27 Xs greater reach [annually 11 M vs 400K]ndash at a lower cost per quit [$291 vs $900]Smokefreegov
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
bull Other cataract diabetes (type 2) erectile dysfunction impaired immune function osteoporosis periodontitis postoperative complications rheumatoid arthritis
US Department of Health and Human Services (USDHHS) (2014)The Health Consequences of Smokingmdash50 Years of Progress A Report of the Surgeon General
25
SMOKING EPIDEMIOLOGY amp HARMS
26
E-cig Aerosol may Containbull Nicotine (even if marketed as 0 nicotine)bull Ultrafine particles that can be inhaled deep into the lungsbull Flavoring such as diacetyl a chemical linked to a serious lung dzbull Volatile organic compounds (VOCs)bull Cancer-causing chemicalsbull Heavy metals such as nickel tin and lead
Primary humectants are propylene glycol and glycerol (aka vegetable glycerin)
At lower levels than in combusted tobacco smoke
27
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
elevated white blood cell countsndash Injuries resembled ldquoexposures to
toxic chemical fumes poisonous gases and toxic agentsrdquo (Mayo)
A diagnosis of exclusion
bull Patient Recommendationsndash Do not use THC-containing vaping
products particularly from informal sources (eg friends family in-person or online sellers)
ndash Vitamin E acetate should not be added to vaping products
Krishnasamy et al (2020) MMWR
28
Reporting EVALI Casesbull CDC encourages clinicians to
continue to report possible EVALI cases to their local or state health department for further investigation
bull If EVALI suspected collect a detailed history ofndash Substances used ndash Sources of products ndash Duration and frequency of usendash Devices used and how used
EVALI Confirmed Case Criteria
29
30
USE amp HARMS SUMMARY
bull Fewer than 1 in 7 US adults are current smokers
bull Smoking prevalence varies by sociodemographic characteristics
bull Nearly half a million US deaths are attributable to smoking annually
bull Smoking costs the US an estimated $300 billion annually
bull E-cigarettes are a diverse product group and their health harms are still being determined
31
OverviewEpidemiology nicotine product landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
32
Counseling7 in 10 tobacco users see a healthcare provider in a given year
Treating tobacco is relevant to all areas of medicine
USPSTF ldquoGrade Ardquo recommendation for clinician-delivered brief tobacco treatment
Counseling by nonphysician health providers also increases quit rates
33
National Cancer Institutersquos 5 As
ASK all patients about use of all forms of tobacco
1
ADVISEtobacco users to quit
2
ASSESS patient readiness to quit
3
ASSIST in the quit attempt with counseling medications amp referrals
ndash Intensive counseling only (without medications) more effective than minimal contact (ie brief advice + self-help materials)
ndash Greater effects when combined with cessation medications
37
COUNSELING SUMMARYbull Routinely identify tobacco users (ASK)bull Strongly ADVISE patients to quitbull ASSESS readiness to quit at each contactbull Tailor intervention messages (ASSIST)
ndash Be a good listenerndash Minimal intervention in absence of time for more
intensive interventionbull ARRANGE follow-up
ndash Use the referral process if needed
38
Tobacco Quitlinesbull Toll-free national portal
ndash Links to state quitline by area code
bull Trained counselors providingndash information self-help materialsndash individual counselingndash local referralsndash may provide free cessation meds
bull Effectiveness well demonstrated bull Reach ~1 of smokers annually
39
Internet Interventionsbull Increasing sophistication + interactionbull Best Practices Individual tailoring
bull Smokefreegovndash Evidence-based tailored to readiness to quitndash Assistance via IM + phone (1-877-44U-QUIT)ndash SmokefreeTXT + Smokefree smartphone
bull Tailored versions for veterans women teens Spanish-speaking and older adults
bull Relative to quitlinesndash 27 Xs greater reach [annually 11 M vs 400K]ndash at a lower cost per quit [$291 vs $900]Smokefreegov
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
bull Other cataract diabetes (type 2) erectile dysfunction impaired immune function osteoporosis periodontitis postoperative complications rheumatoid arthritis
US Department of Health and Human Services (USDHHS) (2014)The Health Consequences of Smokingmdash50 Years of Progress A Report of the Surgeon General
25
SMOKING EPIDEMIOLOGY amp HARMS
26
E-cig Aerosol may Containbull Nicotine (even if marketed as 0 nicotine)bull Ultrafine particles that can be inhaled deep into the lungsbull Flavoring such as diacetyl a chemical linked to a serious lung dzbull Volatile organic compounds (VOCs)bull Cancer-causing chemicalsbull Heavy metals such as nickel tin and lead
Primary humectants are propylene glycol and glycerol (aka vegetable glycerin)
At lower levels than in combusted tobacco smoke
27
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
elevated white blood cell countsndash Injuries resembled ldquoexposures to
toxic chemical fumes poisonous gases and toxic agentsrdquo (Mayo)
A diagnosis of exclusion
bull Patient Recommendationsndash Do not use THC-containing vaping
products particularly from informal sources (eg friends family in-person or online sellers)
ndash Vitamin E acetate should not be added to vaping products
Krishnasamy et al (2020) MMWR
28
Reporting EVALI Casesbull CDC encourages clinicians to
continue to report possible EVALI cases to their local or state health department for further investigation
bull If EVALI suspected collect a detailed history ofndash Substances used ndash Sources of products ndash Duration and frequency of usendash Devices used and how used
EVALI Confirmed Case Criteria
29
30
USE amp HARMS SUMMARY
bull Fewer than 1 in 7 US adults are current smokers
bull Smoking prevalence varies by sociodemographic characteristics
bull Nearly half a million US deaths are attributable to smoking annually
bull Smoking costs the US an estimated $300 billion annually
bull E-cigarettes are a diverse product group and their health harms are still being determined
31
OverviewEpidemiology nicotine product landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
32
Counseling7 in 10 tobacco users see a healthcare provider in a given year
Treating tobacco is relevant to all areas of medicine
USPSTF ldquoGrade Ardquo recommendation for clinician-delivered brief tobacco treatment
Counseling by nonphysician health providers also increases quit rates
33
National Cancer Institutersquos 5 As
ASK all patients about use of all forms of tobacco
1
ADVISEtobacco users to quit
2
ASSESS patient readiness to quit
3
ASSIST in the quit attempt with counseling medications amp referrals
ndash Intensive counseling only (without medications) more effective than minimal contact (ie brief advice + self-help materials)
ndash Greater effects when combined with cessation medications
37
COUNSELING SUMMARYbull Routinely identify tobacco users (ASK)bull Strongly ADVISE patients to quitbull ASSESS readiness to quit at each contactbull Tailor intervention messages (ASSIST)
ndash Be a good listenerndash Minimal intervention in absence of time for more
intensive interventionbull ARRANGE follow-up
ndash Use the referral process if needed
38
Tobacco Quitlinesbull Toll-free national portal
ndash Links to state quitline by area code
bull Trained counselors providingndash information self-help materialsndash individual counselingndash local referralsndash may provide free cessation meds
bull Effectiveness well demonstrated bull Reach ~1 of smokers annually
39
Internet Interventionsbull Increasing sophistication + interactionbull Best Practices Individual tailoring
bull Smokefreegovndash Evidence-based tailored to readiness to quitndash Assistance via IM + phone (1-877-44U-QUIT)ndash SmokefreeTXT + Smokefree smartphone
bull Tailored versions for veterans women teens Spanish-speaking and older adults
bull Relative to quitlinesndash 27 Xs greater reach [annually 11 M vs 400K]ndash at a lower cost per quit [$291 vs $900]Smokefreegov
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
bull Other cataract diabetes (type 2) erectile dysfunction impaired immune function osteoporosis periodontitis postoperative complications rheumatoid arthritis
US Department of Health and Human Services (USDHHS) (2014)The Health Consequences of Smokingmdash50 Years of Progress A Report of the Surgeon General
25
SMOKING EPIDEMIOLOGY amp HARMS
26
E-cig Aerosol may Containbull Nicotine (even if marketed as 0 nicotine)bull Ultrafine particles that can be inhaled deep into the lungsbull Flavoring such as diacetyl a chemical linked to a serious lung dzbull Volatile organic compounds (VOCs)bull Cancer-causing chemicalsbull Heavy metals such as nickel tin and lead
Primary humectants are propylene glycol and glycerol (aka vegetable glycerin)
At lower levels than in combusted tobacco smoke
27
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
elevated white blood cell countsndash Injuries resembled ldquoexposures to
toxic chemical fumes poisonous gases and toxic agentsrdquo (Mayo)
A diagnosis of exclusion
bull Patient Recommendationsndash Do not use THC-containing vaping
products particularly from informal sources (eg friends family in-person or online sellers)
ndash Vitamin E acetate should not be added to vaping products
Krishnasamy et al (2020) MMWR
28
Reporting EVALI Casesbull CDC encourages clinicians to
continue to report possible EVALI cases to their local or state health department for further investigation
bull If EVALI suspected collect a detailed history ofndash Substances used ndash Sources of products ndash Duration and frequency of usendash Devices used and how used
EVALI Confirmed Case Criteria
29
30
USE amp HARMS SUMMARY
bull Fewer than 1 in 7 US adults are current smokers
bull Smoking prevalence varies by sociodemographic characteristics
bull Nearly half a million US deaths are attributable to smoking annually
bull Smoking costs the US an estimated $300 billion annually
bull E-cigarettes are a diverse product group and their health harms are still being determined
31
OverviewEpidemiology nicotine product landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
32
Counseling7 in 10 tobacco users see a healthcare provider in a given year
Treating tobacco is relevant to all areas of medicine
USPSTF ldquoGrade Ardquo recommendation for clinician-delivered brief tobacco treatment
Counseling by nonphysician health providers also increases quit rates
33
National Cancer Institutersquos 5 As
ASK all patients about use of all forms of tobacco
1
ADVISEtobacco users to quit
2
ASSESS patient readiness to quit
3
ASSIST in the quit attempt with counseling medications amp referrals
ndash Intensive counseling only (without medications) more effective than minimal contact (ie brief advice + self-help materials)
ndash Greater effects when combined with cessation medications
37
COUNSELING SUMMARYbull Routinely identify tobacco users (ASK)bull Strongly ADVISE patients to quitbull ASSESS readiness to quit at each contactbull Tailor intervention messages (ASSIST)
ndash Be a good listenerndash Minimal intervention in absence of time for more
intensive interventionbull ARRANGE follow-up
ndash Use the referral process if needed
38
Tobacco Quitlinesbull Toll-free national portal
ndash Links to state quitline by area code
bull Trained counselors providingndash information self-help materialsndash individual counselingndash local referralsndash may provide free cessation meds
bull Effectiveness well demonstrated bull Reach ~1 of smokers annually
39
Internet Interventionsbull Increasing sophistication + interactionbull Best Practices Individual tailoring
bull Smokefreegovndash Evidence-based tailored to readiness to quitndash Assistance via IM + phone (1-877-44U-QUIT)ndash SmokefreeTXT + Smokefree smartphone
bull Tailored versions for veterans women teens Spanish-speaking and older adults
bull Relative to quitlinesndash 27 Xs greater reach [annually 11 M vs 400K]ndash at a lower cost per quit [$291 vs $900]Smokefreegov
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
bull Other cataract diabetes (type 2) erectile dysfunction impaired immune function osteoporosis periodontitis postoperative complications rheumatoid arthritis
US Department of Health and Human Services (USDHHS) (2014)The Health Consequences of Smokingmdash50 Years of Progress A Report of the Surgeon General
25
SMOKING EPIDEMIOLOGY amp HARMS
26
E-cig Aerosol may Containbull Nicotine (even if marketed as 0 nicotine)bull Ultrafine particles that can be inhaled deep into the lungsbull Flavoring such as diacetyl a chemical linked to a serious lung dzbull Volatile organic compounds (VOCs)bull Cancer-causing chemicalsbull Heavy metals such as nickel tin and lead
Primary humectants are propylene glycol and glycerol (aka vegetable glycerin)
At lower levels than in combusted tobacco smoke
27
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
elevated white blood cell countsndash Injuries resembled ldquoexposures to
toxic chemical fumes poisonous gases and toxic agentsrdquo (Mayo)
A diagnosis of exclusion
bull Patient Recommendationsndash Do not use THC-containing vaping
products particularly from informal sources (eg friends family in-person or online sellers)
ndash Vitamin E acetate should not be added to vaping products
Krishnasamy et al (2020) MMWR
28
Reporting EVALI Casesbull CDC encourages clinicians to
continue to report possible EVALI cases to their local or state health department for further investigation
bull If EVALI suspected collect a detailed history ofndash Substances used ndash Sources of products ndash Duration and frequency of usendash Devices used and how used
EVALI Confirmed Case Criteria
29
30
USE amp HARMS SUMMARY
bull Fewer than 1 in 7 US adults are current smokers
bull Smoking prevalence varies by sociodemographic characteristics
bull Nearly half a million US deaths are attributable to smoking annually
bull Smoking costs the US an estimated $300 billion annually
bull E-cigarettes are a diverse product group and their health harms are still being determined
31
OverviewEpidemiology nicotine product landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
32
Counseling7 in 10 tobacco users see a healthcare provider in a given year
Treating tobacco is relevant to all areas of medicine
USPSTF ldquoGrade Ardquo recommendation for clinician-delivered brief tobacco treatment
Counseling by nonphysician health providers also increases quit rates
33
National Cancer Institutersquos 5 As
ASK all patients about use of all forms of tobacco
1
ADVISEtobacco users to quit
2
ASSESS patient readiness to quit
3
ASSIST in the quit attempt with counseling medications amp referrals
ndash Intensive counseling only (without medications) more effective than minimal contact (ie brief advice + self-help materials)
ndash Greater effects when combined with cessation medications
37
COUNSELING SUMMARYbull Routinely identify tobacco users (ASK)bull Strongly ADVISE patients to quitbull ASSESS readiness to quit at each contactbull Tailor intervention messages (ASSIST)
ndash Be a good listenerndash Minimal intervention in absence of time for more
intensive interventionbull ARRANGE follow-up
ndash Use the referral process if needed
38
Tobacco Quitlinesbull Toll-free national portal
ndash Links to state quitline by area code
bull Trained counselors providingndash information self-help materialsndash individual counselingndash local referralsndash may provide free cessation meds
bull Effectiveness well demonstrated bull Reach ~1 of smokers annually
39
Internet Interventionsbull Increasing sophistication + interactionbull Best Practices Individual tailoring
bull Smokefreegovndash Evidence-based tailored to readiness to quitndash Assistance via IM + phone (1-877-44U-QUIT)ndash SmokefreeTXT + Smokefree smartphone
bull Tailored versions for veterans women teens Spanish-speaking and older adults
bull Relative to quitlinesndash 27 Xs greater reach [annually 11 M vs 400K]ndash at a lower cost per quit [$291 vs $900]Smokefreegov
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
bull Other cataract diabetes (type 2) erectile dysfunction impaired immune function osteoporosis periodontitis postoperative complications rheumatoid arthritis
US Department of Health and Human Services (USDHHS) (2014)The Health Consequences of Smokingmdash50 Years of Progress A Report of the Surgeon General
25
SMOKING EPIDEMIOLOGY amp HARMS
26
E-cig Aerosol may Containbull Nicotine (even if marketed as 0 nicotine)bull Ultrafine particles that can be inhaled deep into the lungsbull Flavoring such as diacetyl a chemical linked to a serious lung dzbull Volatile organic compounds (VOCs)bull Cancer-causing chemicalsbull Heavy metals such as nickel tin and lead
Primary humectants are propylene glycol and glycerol (aka vegetable glycerin)
At lower levels than in combusted tobacco smoke
27
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
elevated white blood cell countsndash Injuries resembled ldquoexposures to
toxic chemical fumes poisonous gases and toxic agentsrdquo (Mayo)
A diagnosis of exclusion
bull Patient Recommendationsndash Do not use THC-containing vaping
products particularly from informal sources (eg friends family in-person or online sellers)
ndash Vitamin E acetate should not be added to vaping products
Krishnasamy et al (2020) MMWR
28
Reporting EVALI Casesbull CDC encourages clinicians to
continue to report possible EVALI cases to their local or state health department for further investigation
bull If EVALI suspected collect a detailed history ofndash Substances used ndash Sources of products ndash Duration and frequency of usendash Devices used and how used
EVALI Confirmed Case Criteria
29
30
USE amp HARMS SUMMARY
bull Fewer than 1 in 7 US adults are current smokers
bull Smoking prevalence varies by sociodemographic characteristics
bull Nearly half a million US deaths are attributable to smoking annually
bull Smoking costs the US an estimated $300 billion annually
bull E-cigarettes are a diverse product group and their health harms are still being determined
31
OverviewEpidemiology nicotine product landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
32
Counseling7 in 10 tobacco users see a healthcare provider in a given year
Treating tobacco is relevant to all areas of medicine
USPSTF ldquoGrade Ardquo recommendation for clinician-delivered brief tobacco treatment
Counseling by nonphysician health providers also increases quit rates
33
National Cancer Institutersquos 5 As
ASK all patients about use of all forms of tobacco
1
ADVISEtobacco users to quit
2
ASSESS patient readiness to quit
3
ASSIST in the quit attempt with counseling medications amp referrals
ndash Intensive counseling only (without medications) more effective than minimal contact (ie brief advice + self-help materials)
ndash Greater effects when combined with cessation medications
37
COUNSELING SUMMARYbull Routinely identify tobacco users (ASK)bull Strongly ADVISE patients to quitbull ASSESS readiness to quit at each contactbull Tailor intervention messages (ASSIST)
ndash Be a good listenerndash Minimal intervention in absence of time for more
intensive interventionbull ARRANGE follow-up
ndash Use the referral process if needed
38
Tobacco Quitlinesbull Toll-free national portal
ndash Links to state quitline by area code
bull Trained counselors providingndash information self-help materialsndash individual counselingndash local referralsndash may provide free cessation meds
bull Effectiveness well demonstrated bull Reach ~1 of smokers annually
39
Internet Interventionsbull Increasing sophistication + interactionbull Best Practices Individual tailoring
bull Smokefreegovndash Evidence-based tailored to readiness to quitndash Assistance via IM + phone (1-877-44U-QUIT)ndash SmokefreeTXT + Smokefree smartphone
bull Tailored versions for veterans women teens Spanish-speaking and older adults
bull Relative to quitlinesndash 27 Xs greater reach [annually 11 M vs 400K]ndash at a lower cost per quit [$291 vs $900]Smokefreegov
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
Varenicline
Bupropion
NRT
Placebo
Overall (N= 8058)
4
45
39
37
NPC (N = 3984)
13
22
25
24
PC (N = 4074)
65
67
52
49
To resize chart data range drag lower right corner of range
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
Varenicline
Bupropion
NRT
Placebo
Weeks 9ndash12
38
261
264
137
Weeks 9ndash24
255
188
185
105
Weeks 9ndash12
292
193
204
114
Weeks 9ndash24
183
137
13
83
Weeks 9ndash12
335
226
234
125
Weeks 9ndash24
218
162
157
94
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
25
SMOKING EPIDEMIOLOGY amp HARMS
26
E-cig Aerosol may Containbull Nicotine (even if marketed as 0 nicotine)bull Ultrafine particles that can be inhaled deep into the lungsbull Flavoring such as diacetyl a chemical linked to a serious lung dzbull Volatile organic compounds (VOCs)bull Cancer-causing chemicalsbull Heavy metals such as nickel tin and lead
Primary humectants are propylene glycol and glycerol (aka vegetable glycerin)
At lower levels than in combusted tobacco smoke
27
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
elevated white blood cell countsndash Injuries resembled ldquoexposures to
toxic chemical fumes poisonous gases and toxic agentsrdquo (Mayo)
A diagnosis of exclusion
bull Patient Recommendationsndash Do not use THC-containing vaping
products particularly from informal sources (eg friends family in-person or online sellers)
ndash Vitamin E acetate should not be added to vaping products
Krishnasamy et al (2020) MMWR
28
Reporting EVALI Casesbull CDC encourages clinicians to
continue to report possible EVALI cases to their local or state health department for further investigation
bull If EVALI suspected collect a detailed history ofndash Substances used ndash Sources of products ndash Duration and frequency of usendash Devices used and how used
EVALI Confirmed Case Criteria
29
30
USE amp HARMS SUMMARY
bull Fewer than 1 in 7 US adults are current smokers
bull Smoking prevalence varies by sociodemographic characteristics
bull Nearly half a million US deaths are attributable to smoking annually
bull Smoking costs the US an estimated $300 billion annually
bull E-cigarettes are a diverse product group and their health harms are still being determined
31
OverviewEpidemiology nicotine product landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
32
Counseling7 in 10 tobacco users see a healthcare provider in a given year
Treating tobacco is relevant to all areas of medicine
USPSTF ldquoGrade Ardquo recommendation for clinician-delivered brief tobacco treatment
Counseling by nonphysician health providers also increases quit rates
33
National Cancer Institutersquos 5 As
ASK all patients about use of all forms of tobacco
1
ADVISEtobacco users to quit
2
ASSESS patient readiness to quit
3
ASSIST in the quit attempt with counseling medications amp referrals
ndash Intensive counseling only (without medications) more effective than minimal contact (ie brief advice + self-help materials)
ndash Greater effects when combined with cessation medications
37
COUNSELING SUMMARYbull Routinely identify tobacco users (ASK)bull Strongly ADVISE patients to quitbull ASSESS readiness to quit at each contactbull Tailor intervention messages (ASSIST)
ndash Be a good listenerndash Minimal intervention in absence of time for more
intensive interventionbull ARRANGE follow-up
ndash Use the referral process if needed
38
Tobacco Quitlinesbull Toll-free national portal
ndash Links to state quitline by area code
bull Trained counselors providingndash information self-help materialsndash individual counselingndash local referralsndash may provide free cessation meds
bull Effectiveness well demonstrated bull Reach ~1 of smokers annually
39
Internet Interventionsbull Increasing sophistication + interactionbull Best Practices Individual tailoring
bull Smokefreegovndash Evidence-based tailored to readiness to quitndash Assistance via IM + phone (1-877-44U-QUIT)ndash SmokefreeTXT + Smokefree smartphone
bull Tailored versions for veterans women teens Spanish-speaking and older adults
bull Relative to quitlinesndash 27 Xs greater reach [annually 11 M vs 400K]ndash at a lower cost per quit [$291 vs $900]Smokefreegov
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
Varenicline
Bupropion
NRT
Placebo
Overall (N= 8058)
4
45
39
37
NPC (N = 3984)
13
22
25
24
PC (N = 4074)
65
67
52
49
To resize chart data range drag lower right corner of range
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
Varenicline
Bupropion
NRT
Placebo
Weeks 9ndash12
38
261
264
137
Weeks 9ndash24
255
188
185
105
Weeks 9ndash12
292
193
204
114
Weeks 9ndash24
183
137
13
83
Weeks 9ndash12
335
226
234
125
Weeks 9ndash24
218
162
157
94
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
26
E-cig Aerosol may Containbull Nicotine (even if marketed as 0 nicotine)bull Ultrafine particles that can be inhaled deep into the lungsbull Flavoring such as diacetyl a chemical linked to a serious lung dzbull Volatile organic compounds (VOCs)bull Cancer-causing chemicalsbull Heavy metals such as nickel tin and lead
Primary humectants are propylene glycol and glycerol (aka vegetable glycerin)
At lower levels than in combusted tobacco smoke
27
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
elevated white blood cell countsndash Injuries resembled ldquoexposures to
toxic chemical fumes poisonous gases and toxic agentsrdquo (Mayo)
A diagnosis of exclusion
bull Patient Recommendationsndash Do not use THC-containing vaping
products particularly from informal sources (eg friends family in-person or online sellers)
ndash Vitamin E acetate should not be added to vaping products
Krishnasamy et al (2020) MMWR
28
Reporting EVALI Casesbull CDC encourages clinicians to
continue to report possible EVALI cases to their local or state health department for further investigation
bull If EVALI suspected collect a detailed history ofndash Substances used ndash Sources of products ndash Duration and frequency of usendash Devices used and how used
EVALI Confirmed Case Criteria
29
30
USE amp HARMS SUMMARY
bull Fewer than 1 in 7 US adults are current smokers
bull Smoking prevalence varies by sociodemographic characteristics
bull Nearly half a million US deaths are attributable to smoking annually
bull Smoking costs the US an estimated $300 billion annually
bull E-cigarettes are a diverse product group and their health harms are still being determined
31
OverviewEpidemiology nicotine product landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
32
Counseling7 in 10 tobacco users see a healthcare provider in a given year
Treating tobacco is relevant to all areas of medicine
USPSTF ldquoGrade Ardquo recommendation for clinician-delivered brief tobacco treatment
Counseling by nonphysician health providers also increases quit rates
33
National Cancer Institutersquos 5 As
ASK all patients about use of all forms of tobacco
1
ADVISEtobacco users to quit
2
ASSESS patient readiness to quit
3
ASSIST in the quit attempt with counseling medications amp referrals
ndash Intensive counseling only (without medications) more effective than minimal contact (ie brief advice + self-help materials)
ndash Greater effects when combined with cessation medications
37
COUNSELING SUMMARYbull Routinely identify tobacco users (ASK)bull Strongly ADVISE patients to quitbull ASSESS readiness to quit at each contactbull Tailor intervention messages (ASSIST)
ndash Be a good listenerndash Minimal intervention in absence of time for more
intensive interventionbull ARRANGE follow-up
ndash Use the referral process if needed
38
Tobacco Quitlinesbull Toll-free national portal
ndash Links to state quitline by area code
bull Trained counselors providingndash information self-help materialsndash individual counselingndash local referralsndash may provide free cessation meds
bull Effectiveness well demonstrated bull Reach ~1 of smokers annually
39
Internet Interventionsbull Increasing sophistication + interactionbull Best Practices Individual tailoring
bull Smokefreegovndash Evidence-based tailored to readiness to quitndash Assistance via IM + phone (1-877-44U-QUIT)ndash SmokefreeTXT + Smokefree smartphone
bull Tailored versions for veterans women teens Spanish-speaking and older adults
bull Relative to quitlinesndash 27 Xs greater reach [annually 11 M vs 400K]ndash at a lower cost per quit [$291 vs $900]Smokefreegov
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
elevated white blood cell countsndash Injuries resembled ldquoexposures to
toxic chemical fumes poisonous gases and toxic agentsrdquo (Mayo)
A diagnosis of exclusion
bull Patient Recommendationsndash Do not use THC-containing vaping
products particularly from informal sources (eg friends family in-person or online sellers)
ndash Vitamin E acetate should not be added to vaping products
Krishnasamy et al (2020) MMWR
28
Reporting EVALI Casesbull CDC encourages clinicians to
continue to report possible EVALI cases to their local or state health department for further investigation
bull If EVALI suspected collect a detailed history ofndash Substances used ndash Sources of products ndash Duration and frequency of usendash Devices used and how used
EVALI Confirmed Case Criteria
29
30
USE amp HARMS SUMMARY
bull Fewer than 1 in 7 US adults are current smokers
bull Smoking prevalence varies by sociodemographic characteristics
bull Nearly half a million US deaths are attributable to smoking annually
bull Smoking costs the US an estimated $300 billion annually
bull E-cigarettes are a diverse product group and their health harms are still being determined
31
OverviewEpidemiology nicotine product landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
32
Counseling7 in 10 tobacco users see a healthcare provider in a given year
Treating tobacco is relevant to all areas of medicine
USPSTF ldquoGrade Ardquo recommendation for clinician-delivered brief tobacco treatment
Counseling by nonphysician health providers also increases quit rates
33
National Cancer Institutersquos 5 As
ASK all patients about use of all forms of tobacco
1
ADVISEtobacco users to quit
2
ASSESS patient readiness to quit
3
ASSIST in the quit attempt with counseling medications amp referrals
ndash Intensive counseling only (without medications) more effective than minimal contact (ie brief advice + self-help materials)
ndash Greater effects when combined with cessation medications
37
COUNSELING SUMMARYbull Routinely identify tobacco users (ASK)bull Strongly ADVISE patients to quitbull ASSESS readiness to quit at each contactbull Tailor intervention messages (ASSIST)
ndash Be a good listenerndash Minimal intervention in absence of time for more
intensive interventionbull ARRANGE follow-up
ndash Use the referral process if needed
38
Tobacco Quitlinesbull Toll-free national portal
ndash Links to state quitline by area code
bull Trained counselors providingndash information self-help materialsndash individual counselingndash local referralsndash may provide free cessation meds
bull Effectiveness well demonstrated bull Reach ~1 of smokers annually
39
Internet Interventionsbull Increasing sophistication + interactionbull Best Practices Individual tailoring
bull Smokefreegovndash Evidence-based tailored to readiness to quitndash Assistance via IM + phone (1-877-44U-QUIT)ndash SmokefreeTXT + Smokefree smartphone
bull Tailored versions for veterans women teens Spanish-speaking and older adults
bull Relative to quitlinesndash 27 Xs greater reach [annually 11 M vs 400K]ndash at a lower cost per quit [$291 vs $900]Smokefreegov
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
Varenicline
Bupropion
NRT
Placebo
Overall (N= 8058)
4
45
39
37
NPC (N = 3984)
13
22
25
24
PC (N = 4074)
65
67
52
49
To resize chart data range drag lower right corner of range
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
Varenicline
Bupropion
NRT
Placebo
Weeks 9ndash12
38
261
264
137
Weeks 9ndash24
255
188
185
105
Weeks 9ndash12
292
193
204
114
Weeks 9ndash24
183
137
13
83
Weeks 9ndash12
335
226
234
125
Weeks 9ndash24
218
162
157
94
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
28
Reporting EVALI Casesbull CDC encourages clinicians to
continue to report possible EVALI cases to their local or state health department for further investigation
bull If EVALI suspected collect a detailed history ofndash Substances used ndash Sources of products ndash Duration and frequency of usendash Devices used and how used
EVALI Confirmed Case Criteria
29
30
USE amp HARMS SUMMARY
bull Fewer than 1 in 7 US adults are current smokers
bull Smoking prevalence varies by sociodemographic characteristics
bull Nearly half a million US deaths are attributable to smoking annually
bull Smoking costs the US an estimated $300 billion annually
bull E-cigarettes are a diverse product group and their health harms are still being determined
31
OverviewEpidemiology nicotine product landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
32
Counseling7 in 10 tobacco users see a healthcare provider in a given year
Treating tobacco is relevant to all areas of medicine
USPSTF ldquoGrade Ardquo recommendation for clinician-delivered brief tobacco treatment
Counseling by nonphysician health providers also increases quit rates
33
National Cancer Institutersquos 5 As
ASK all patients about use of all forms of tobacco
1
ADVISEtobacco users to quit
2
ASSESS patient readiness to quit
3
ASSIST in the quit attempt with counseling medications amp referrals
ndash Intensive counseling only (without medications) more effective than minimal contact (ie brief advice + self-help materials)
ndash Greater effects when combined with cessation medications
37
COUNSELING SUMMARYbull Routinely identify tobacco users (ASK)bull Strongly ADVISE patients to quitbull ASSESS readiness to quit at each contactbull Tailor intervention messages (ASSIST)
ndash Be a good listenerndash Minimal intervention in absence of time for more
intensive interventionbull ARRANGE follow-up
ndash Use the referral process if needed
38
Tobacco Quitlinesbull Toll-free national portal
ndash Links to state quitline by area code
bull Trained counselors providingndash information self-help materialsndash individual counselingndash local referralsndash may provide free cessation meds
bull Effectiveness well demonstrated bull Reach ~1 of smokers annually
39
Internet Interventionsbull Increasing sophistication + interactionbull Best Practices Individual tailoring
bull Smokefreegovndash Evidence-based tailored to readiness to quitndash Assistance via IM + phone (1-877-44U-QUIT)ndash SmokefreeTXT + Smokefree smartphone
bull Tailored versions for veterans women teens Spanish-speaking and older adults
bull Relative to quitlinesndash 27 Xs greater reach [annually 11 M vs 400K]ndash at a lower cost per quit [$291 vs $900]Smokefreegov
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
ndash Intensive counseling only (without medications) more effective than minimal contact (ie brief advice + self-help materials)
ndash Greater effects when combined with cessation medications
37
COUNSELING SUMMARYbull Routinely identify tobacco users (ASK)bull Strongly ADVISE patients to quitbull ASSESS readiness to quit at each contactbull Tailor intervention messages (ASSIST)
ndash Be a good listenerndash Minimal intervention in absence of time for more
intensive interventionbull ARRANGE follow-up
ndash Use the referral process if needed
38
Tobacco Quitlinesbull Toll-free national portal
ndash Links to state quitline by area code
bull Trained counselors providingndash information self-help materialsndash individual counselingndash local referralsndash may provide free cessation meds
bull Effectiveness well demonstrated bull Reach ~1 of smokers annually
39
Internet Interventionsbull Increasing sophistication + interactionbull Best Practices Individual tailoring
bull Smokefreegovndash Evidence-based tailored to readiness to quitndash Assistance via IM + phone (1-877-44U-QUIT)ndash SmokefreeTXT + Smokefree smartphone
bull Tailored versions for veterans women teens Spanish-speaking and older adults
bull Relative to quitlinesndash 27 Xs greater reach [annually 11 M vs 400K]ndash at a lower cost per quit [$291 vs $900]Smokefreegov
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
ndash Intensive counseling only (without medications) more effective than minimal contact (ie brief advice + self-help materials)
ndash Greater effects when combined with cessation medications
37
COUNSELING SUMMARYbull Routinely identify tobacco users (ASK)bull Strongly ADVISE patients to quitbull ASSESS readiness to quit at each contactbull Tailor intervention messages (ASSIST)
ndash Be a good listenerndash Minimal intervention in absence of time for more
intensive interventionbull ARRANGE follow-up
ndash Use the referral process if needed
38
Tobacco Quitlinesbull Toll-free national portal
ndash Links to state quitline by area code
bull Trained counselors providingndash information self-help materialsndash individual counselingndash local referralsndash may provide free cessation meds
bull Effectiveness well demonstrated bull Reach ~1 of smokers annually
39
Internet Interventionsbull Increasing sophistication + interactionbull Best Practices Individual tailoring
bull Smokefreegovndash Evidence-based tailored to readiness to quitndash Assistance via IM + phone (1-877-44U-QUIT)ndash SmokefreeTXT + Smokefree smartphone
bull Tailored versions for veterans women teens Spanish-speaking and older adults
bull Relative to quitlinesndash 27 Xs greater reach [annually 11 M vs 400K]ndash at a lower cost per quit [$291 vs $900]Smokefreegov
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
ndash Intensive counseling only (without medications) more effective than minimal contact (ie brief advice + self-help materials)
ndash Greater effects when combined with cessation medications
37
COUNSELING SUMMARYbull Routinely identify tobacco users (ASK)bull Strongly ADVISE patients to quitbull ASSESS readiness to quit at each contactbull Tailor intervention messages (ASSIST)
ndash Be a good listenerndash Minimal intervention in absence of time for more
intensive interventionbull ARRANGE follow-up
ndash Use the referral process if needed
38
Tobacco Quitlinesbull Toll-free national portal
ndash Links to state quitline by area code
bull Trained counselors providingndash information self-help materialsndash individual counselingndash local referralsndash may provide free cessation meds
bull Effectiveness well demonstrated bull Reach ~1 of smokers annually
39
Internet Interventionsbull Increasing sophistication + interactionbull Best Practices Individual tailoring
bull Smokefreegovndash Evidence-based tailored to readiness to quitndash Assistance via IM + phone (1-877-44U-QUIT)ndash SmokefreeTXT + Smokefree smartphone
bull Tailored versions for veterans women teens Spanish-speaking and older adults
bull Relative to quitlinesndash 27 Xs greater reach [annually 11 M vs 400K]ndash at a lower cost per quit [$291 vs $900]Smokefreegov
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
ndash Intensive counseling only (without medications) more effective than minimal contact (ie brief advice + self-help materials)
ndash Greater effects when combined with cessation medications
37
COUNSELING SUMMARYbull Routinely identify tobacco users (ASK)bull Strongly ADVISE patients to quitbull ASSESS readiness to quit at each contactbull Tailor intervention messages (ASSIST)
ndash Be a good listenerndash Minimal intervention in absence of time for more
intensive interventionbull ARRANGE follow-up
ndash Use the referral process if needed
38
Tobacco Quitlinesbull Toll-free national portal
ndash Links to state quitline by area code
bull Trained counselors providingndash information self-help materialsndash individual counselingndash local referralsndash may provide free cessation meds
bull Effectiveness well demonstrated bull Reach ~1 of smokers annually
39
Internet Interventionsbull Increasing sophistication + interactionbull Best Practices Individual tailoring
bull Smokefreegovndash Evidence-based tailored to readiness to quitndash Assistance via IM + phone (1-877-44U-QUIT)ndash SmokefreeTXT + Smokefree smartphone
bull Tailored versions for veterans women teens Spanish-speaking and older adults
bull Relative to quitlinesndash 27 Xs greater reach [annually 11 M vs 400K]ndash at a lower cost per quit [$291 vs $900]Smokefreegov
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
ndash Intensive counseling only (without medications) more effective than minimal contact (ie brief advice + self-help materials)
ndash Greater effects when combined with cessation medications
37
COUNSELING SUMMARYbull Routinely identify tobacco users (ASK)bull Strongly ADVISE patients to quitbull ASSESS readiness to quit at each contactbull Tailor intervention messages (ASSIST)
ndash Be a good listenerndash Minimal intervention in absence of time for more
intensive interventionbull ARRANGE follow-up
ndash Use the referral process if needed
38
Tobacco Quitlinesbull Toll-free national portal
ndash Links to state quitline by area code
bull Trained counselors providingndash information self-help materialsndash individual counselingndash local referralsndash may provide free cessation meds
bull Effectiveness well demonstrated bull Reach ~1 of smokers annually
39
Internet Interventionsbull Increasing sophistication + interactionbull Best Practices Individual tailoring
bull Smokefreegovndash Evidence-based tailored to readiness to quitndash Assistance via IM + phone (1-877-44U-QUIT)ndash SmokefreeTXT + Smokefree smartphone
bull Tailored versions for veterans women teens Spanish-speaking and older adults
bull Relative to quitlinesndash 27 Xs greater reach [annually 11 M vs 400K]ndash at a lower cost per quit [$291 vs $900]Smokefreegov
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
ndash Intensive counseling only (without medications) more effective than minimal contact (ie brief advice + self-help materials)
ndash Greater effects when combined with cessation medications
37
COUNSELING SUMMARYbull Routinely identify tobacco users (ASK)bull Strongly ADVISE patients to quitbull ASSESS readiness to quit at each contactbull Tailor intervention messages (ASSIST)
ndash Be a good listenerndash Minimal intervention in absence of time for more
intensive interventionbull ARRANGE follow-up
ndash Use the referral process if needed
38
Tobacco Quitlinesbull Toll-free national portal
ndash Links to state quitline by area code
bull Trained counselors providingndash information self-help materialsndash individual counselingndash local referralsndash may provide free cessation meds
bull Effectiveness well demonstrated bull Reach ~1 of smokers annually
39
Internet Interventionsbull Increasing sophistication + interactionbull Best Practices Individual tailoring
bull Smokefreegovndash Evidence-based tailored to readiness to quitndash Assistance via IM + phone (1-877-44U-QUIT)ndash SmokefreeTXT + Smokefree smartphone
bull Tailored versions for veterans women teens Spanish-speaking and older adults
bull Relative to quitlinesndash 27 Xs greater reach [annually 11 M vs 400K]ndash at a lower cost per quit [$291 vs $900]Smokefreegov
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
ndash Intensive counseling only (without medications) more effective than minimal contact (ie brief advice + self-help materials)
ndash Greater effects when combined with cessation medications
37
COUNSELING SUMMARYbull Routinely identify tobacco users (ASK)bull Strongly ADVISE patients to quitbull ASSESS readiness to quit at each contactbull Tailor intervention messages (ASSIST)
ndash Be a good listenerndash Minimal intervention in absence of time for more
intensive interventionbull ARRANGE follow-up
ndash Use the referral process if needed
38
Tobacco Quitlinesbull Toll-free national portal
ndash Links to state quitline by area code
bull Trained counselors providingndash information self-help materialsndash individual counselingndash local referralsndash may provide free cessation meds
bull Effectiveness well demonstrated bull Reach ~1 of smokers annually
39
Internet Interventionsbull Increasing sophistication + interactionbull Best Practices Individual tailoring
bull Smokefreegovndash Evidence-based tailored to readiness to quitndash Assistance via IM + phone (1-877-44U-QUIT)ndash SmokefreeTXT + Smokefree smartphone
bull Tailored versions for veterans women teens Spanish-speaking and older adults
bull Relative to quitlinesndash 27 Xs greater reach [annually 11 M vs 400K]ndash at a lower cost per quit [$291 vs $900]Smokefreegov
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
ndash Intensive counseling only (without medications) more effective than minimal contact (ie brief advice + self-help materials)
ndash Greater effects when combined with cessation medications
37
COUNSELING SUMMARYbull Routinely identify tobacco users (ASK)bull Strongly ADVISE patients to quitbull ASSESS readiness to quit at each contactbull Tailor intervention messages (ASSIST)
ndash Be a good listenerndash Minimal intervention in absence of time for more
intensive interventionbull ARRANGE follow-up
ndash Use the referral process if needed
38
Tobacco Quitlinesbull Toll-free national portal
ndash Links to state quitline by area code
bull Trained counselors providingndash information self-help materialsndash individual counselingndash local referralsndash may provide free cessation meds
bull Effectiveness well demonstrated bull Reach ~1 of smokers annually
39
Internet Interventionsbull Increasing sophistication + interactionbull Best Practices Individual tailoring
bull Smokefreegovndash Evidence-based tailored to readiness to quitndash Assistance via IM + phone (1-877-44U-QUIT)ndash SmokefreeTXT + Smokefree smartphone
bull Tailored versions for veterans women teens Spanish-speaking and older adults
bull Relative to quitlinesndash 27 Xs greater reach [annually 11 M vs 400K]ndash at a lower cost per quit [$291 vs $900]Smokefreegov
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
Varenicline
Bupropion
NRT
Placebo
Overall (N= 8058)
4
45
39
37
NPC (N = 3984)
13
22
25
24
PC (N = 4074)
65
67
52
49
To resize chart data range drag lower right corner of range
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
Varenicline
Bupropion
NRT
Placebo
Weeks 9ndash12
38
261
264
137
Weeks 9ndash24
255
188
185
105
Weeks 9ndash12
292
193
204
114
Weeks 9ndash24
183
137
13
83
Weeks 9ndash12
335
226
234
125
Weeks 9ndash24
218
162
157
94
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
37
COUNSELING SUMMARYbull Routinely identify tobacco users (ASK)bull Strongly ADVISE patients to quitbull ASSESS readiness to quit at each contactbull Tailor intervention messages (ASSIST)
ndash Be a good listenerndash Minimal intervention in absence of time for more
intensive interventionbull ARRANGE follow-up
ndash Use the referral process if needed
38
Tobacco Quitlinesbull Toll-free national portal
ndash Links to state quitline by area code
bull Trained counselors providingndash information self-help materialsndash individual counselingndash local referralsndash may provide free cessation meds
bull Effectiveness well demonstrated bull Reach ~1 of smokers annually
39
Internet Interventionsbull Increasing sophistication + interactionbull Best Practices Individual tailoring
bull Smokefreegovndash Evidence-based tailored to readiness to quitndash Assistance via IM + phone (1-877-44U-QUIT)ndash SmokefreeTXT + Smokefree smartphone
bull Tailored versions for veterans women teens Spanish-speaking and older adults
bull Relative to quitlinesndash 27 Xs greater reach [annually 11 M vs 400K]ndash at a lower cost per quit [$291 vs $900]Smokefreegov
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
Varenicline
Bupropion
NRT
Placebo
Overall (N= 8058)
4
45
39
37
NPC (N = 3984)
13
22
25
24
PC (N = 4074)
65
67
52
49
To resize chart data range drag lower right corner of range
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
Varenicline
Bupropion
NRT
Placebo
Weeks 9ndash12
38
261
264
137
Weeks 9ndash24
255
188
185
105
Weeks 9ndash12
292
193
204
114
Weeks 9ndash24
183
137
13
83
Weeks 9ndash12
335
226
234
125
Weeks 9ndash24
218
162
157
94
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
38
Tobacco Quitlinesbull Toll-free national portal
ndash Links to state quitline by area code
bull Trained counselors providingndash information self-help materialsndash individual counselingndash local referralsndash may provide free cessation meds
bull Effectiveness well demonstrated bull Reach ~1 of smokers annually
39
Internet Interventionsbull Increasing sophistication + interactionbull Best Practices Individual tailoring
bull Smokefreegovndash Evidence-based tailored to readiness to quitndash Assistance via IM + phone (1-877-44U-QUIT)ndash SmokefreeTXT + Smokefree smartphone
bull Tailored versions for veterans women teens Spanish-speaking and older adults
bull Relative to quitlinesndash 27 Xs greater reach [annually 11 M vs 400K]ndash at a lower cost per quit [$291 vs $900]Smokefreegov
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
Varenicline
Bupropion
NRT
Placebo
Overall (N= 8058)
4
45
39
37
NPC (N = 3984)
13
22
25
24
PC (N = 4074)
65
67
52
49
To resize chart data range drag lower right corner of range
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
Varenicline
Bupropion
NRT
Placebo
Weeks 9ndash12
38
261
264
137
Weeks 9ndash24
255
188
185
105
Weeks 9ndash12
292
193
204
114
Weeks 9ndash24
183
137
13
83
Weeks 9ndash12
335
226
234
125
Weeks 9ndash24
218
162
157
94
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
39
Internet Interventionsbull Increasing sophistication + interactionbull Best Practices Individual tailoring
bull Smokefreegovndash Evidence-based tailored to readiness to quitndash Assistance via IM + phone (1-877-44U-QUIT)ndash SmokefreeTXT + Smokefree smartphone
bull Tailored versions for veterans women teens Spanish-speaking and older adults
bull Relative to quitlinesndash 27 Xs greater reach [annually 11 M vs 400K]ndash at a lower cost per quit [$291 vs $900]Smokefreegov
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
Varenicline
Bupropion
NRT
Placebo
Overall (N= 8058)
4
45
39
37
NPC (N = 3984)
13
22
25
24
PC (N = 4074)
65
67
52
49
To resize chart data range drag lower right corner of range
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
Varenicline
Bupropion
NRT
Placebo
Weeks 9ndash12
38
261
264
137
Weeks 9ndash24
255
188
185
105
Weeks 9ndash12
292
193
204
114
Weeks 9ndash24
183
137
13
83
Weeks 9ndash12
335
226
234
125
Weeks 9ndash24
218
162
157
94
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
40
2014 search 546 quit smoking apps in the Apple Store and on Google Play
32 M downloads US + 20 M global
Broad reach and high scalability
2015 review of 225 Android quit smoking appsMost provide simplistic tools (eg calculators + trackers) Use of tailoring limited although positively related to app popularity and user ratings of quality
Evaluation of intervention effects on quitting smoking is sorely needed
41
Social Mediabull 72 of US adults use social media
ndash 80 are seeking health information
ndash Most access the sites daily
bull Efforts to sustain engagement are key and can be challenging
bull Preliminary evidence of good acceptability and efficacy
42
MONETARY INCENTIVES
bull Reward outcome (ie abstinence) or participation (ie engagement)
bull Meta-analysis 33 trials increased abstinence persisted after incentives ceased
bull Incentives $0 (self-deposits) to $45 -- $1185 no clear difference by level
bull Conditional (ie $ for abstinence) outperformed nonconditional $bull Smokers w substance use problems = similar outcomesbull Pregnant smokers gt 2-fold greater abstinence thru 24 wks
postpartum
43
OverviewEpidemiology nicotine product
landscape use patterns addiction and health harms
Counseling modalities for delivery of behavioral counseling (eg quitlines web text app interventions)
Pharmacotherapy new approaches to medications (eg combination medications pre-loading)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
2Reduce rewarding effects of nicotine from smoking by blocking or desensitizing nicotine receptors
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
Varenicline
Bupropion
NRT
Placebo
Overall (N= 8058)
4
45
39
37
NPC (N = 3984)
13
22
25
24
PC (N = 4074)
65
67
52
49
To resize chart data range drag lower right corner of range
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
Varenicline
Bupropion
NRT
Placebo
Weeks 9ndash12
38
261
264
137
Weeks 9ndash24
255
188
185
105
Weeks 9ndash12
292
193
204
114
Weeks 9ndash24
183
137
13
83
Weeks 9ndash12
335
226
234
125
Weeks 9ndash24
218
162
157
94
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
45
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
Dopamine
Norepinephrine
Acetylcholine
Glutamate
β-Endorphin
GABA
Serotonin
NICOTINE
Pleasure rewardArousal appetite suppressionArousal cognitive enhancementLearning memory enhancementReduction of anxiety and tensionReduction of anxiety and tensionMood modulation appetite suppression
46
NICOTINE WITHDRAWAL EFFECTS
bull Dysphoric or depressed mood
bull Insomnia and fatigue
bull Irritability frustration anger
bull Anxiety or nervousness
bull Difficulty concentrating
bull Increased appetite weight gain
bull Restlessness and impatience
bull Cravings
47
NICOTINE ADDICTION
CYCLE
48
FDA APPROVALS SMOKING CESSATION
1984
Rx nicotine
gum
1991
19961997
Rx nicotine inhaler
Rx bupropion SR
2002
OTC nicotine lozenge
2006
Rx varenicline
Rx transdermal nicotine patch
OTC nicotine gum amp patchRx nicotine nasal spray
49
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
Source RxforChange with data from Fant et al 1999 Schneider et al 2001 Choi et al 2003
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
Varenicline
Bupropion
NRT
Placebo
Overall (N= 8058)
4
45
39
37
NPC (N = 3984)
13
22
25
24
PC (N = 4074)
65
67
52
49
To resize chart data range drag lower right corner of range
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
Varenicline
Bupropion
NRT
Placebo
Weeks 9ndash12
38
261
264
137
Weeks 9ndash24
255
188
185
105
Weeks 9ndash12
292
193
204
114
Weeks 9ndash24
183
137
13
83
Weeks 9ndash12
335
226
234
125
Weeks 9ndash24
218
162
157
94
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
50
Nicotine Replacement
Therapies (NRT)
approx 1 cig = 1 mg
time to first cigarette upon wakening (lt 30m)
combination NRT
Gum otc
Patches otc
Lozenge otc
Nasal spray
Inhaler
Nicotine mouth spray
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
Varenicline
Bupropion
NRT
Placebo
Overall (N= 8058)
4
45
39
37
NPC (N = 3984)
13
22
25
24
PC (N = 4074)
65
67
52
49
To resize chart data range drag lower right corner of range
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
Varenicline
Bupropion
NRT
Placebo
Weeks 9ndash12
38
261
264
137
Weeks 9ndash24
255
188
185
105
Weeks 9ndash12
292
193
204
114
Weeks 9ndash24
183
137
13
83
Weeks 9ndash12
335
226
234
125
Weeks 9ndash24
218
162
157
94
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
51
NICOTINE rdquoGUMrdquo
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
Varenicline
Bupropion
NRT
Placebo
Overall (N= 8058)
4
45
39
37
NPC (N = 3984)
13
22
25
24
PC (N = 4074)
65
67
52
49
To resize chart data range drag lower right corner of range
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
Varenicline
Bupropion
NRT
Placebo
Weeks 9ndash12
38
261
264
137
Weeks 9ndash24
255
188
185
105
Weeks 9ndash12
292
193
204
114
Weeks 9ndash24
183
137
13
83
Weeks 9ndash12
335
226
234
125
Weeks 9ndash24
218
162
157
94
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
52
NICOTINE ldquoINHALERrdquo
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
Varenicline
Bupropion
NRT
Placebo
Overall (N= 8058)
4
45
39
37
NPC (N = 3984)
13
22
25
24
PC (N = 4074)
65
67
52
49
To resize chart data range drag lower right corner of range
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
Varenicline
Bupropion
NRT
Placebo
Weeks 9ndash12
38
261
264
137
Weeks 9ndash24
255
188
185
105
Weeks 9ndash12
292
193
204
114
Weeks 9ndash24
183
137
13
83
Weeks 9ndash12
335
226
234
125
Weeks 9ndash24
218
162
157
94
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
53
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
Varenicline
Bupropion
NRT
Placebo
Overall (N= 8058)
4
45
39
37
NPC (N = 3984)
13
22
25
24
PC (N = 4074)
65
67
52
49
To resize chart data range drag lower right corner of range
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
Varenicline
Bupropion
NRT
Placebo
Weeks 9ndash12
38
261
264
137
Weeks 9ndash24
255
188
185
105
Weeks 9ndash12
292
193
204
114
Weeks 9ndash24
183
137
13
83
Weeks 9ndash12
335
226
234
125
Weeks 9ndash24
218
162
157
94
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
54
Q What two items inform dosing of nicotine replacement therapy
A Number of failed prior quit attemptsB Cigarettes per dayC Time to first cigarette upon wakeningD Number of withdrawal symptoms
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
Varenicline
Bupropion
NRT
Placebo
Overall (N= 8058)
4
45
39
37
NPC (N = 3984)
13
22
25
24
PC (N = 4074)
65
67
52
49
To resize chart data range drag lower right corner of range
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
Varenicline
Bupropion
NRT
Placebo
Weeks 9ndash12
38
261
264
137
Weeks 9ndash24
255
188
185
105
Weeks 9ndash12
292
193
204
114
Weeks 9ndash24
183
137
13
83
Weeks 9ndash12
335
226
234
125
Weeks 9ndash24
218
162
157
94
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
55
Dosing of NRTbull Key indicators of addiction
ndash Time to first cigarette upon wakingndash Cigarettes per day
bull Both are used to dose NRT bull Nicotine gum or lozenge
ndash 4 mg if smoke within 30 mins of wakingndash 2 mg if smoke after 30 mins of waking
bull Nicotine patch ndash Start with 21 mg patch if smoke gt10 CPDndash Start with 14 mg patch if smoke le10 CPD
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
Varenicline
Bupropion
NRT
Placebo
Overall (N= 8058)
4
45
39
37
NPC (N = 3984)
13
22
25
24
PC (N = 4074)
65
67
52
49
To resize chart data range drag lower right corner of range
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
Varenicline
Bupropion
NRT
Placebo
Weeks 9ndash12
38
261
264
137
Weeks 9ndash24
255
188
185
105
Weeks 9ndash12
292
193
204
114
Weeks 9ndash24
183
137
13
83
Weeks 9ndash12
335
226
234
125
Weeks 9ndash24
218
162
157
94
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
56
Bupropion
Atypical antidepressant with
dopaminergic + noradrenergic
properties
Start 2 wks before quit date
Primary active chemical is hydroxybupropion which takes
7 days to reach steady state
Can be used in combination with NRT
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
Varenicline
Bupropion
NRT
Placebo
Overall (N= 8058)
4
45
39
37
NPC (N = 3984)
13
22
25
24
PC (N = 4074)
65
67
52
49
To resize chart data range drag lower right corner of range
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
Varenicline
Bupropion
NRT
Placebo
Weeks 9ndash12
38
261
264
137
Weeks 9ndash24
255
188
185
105
Weeks 9ndash12
292
193
204
114
Weeks 9ndash24
183
137
13
83
Weeks 9ndash12
335
226
234
125
Weeks 9ndash24
218
162
157
94
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
57
Vareniclinebull Partial agonist at nicotinic prop4Ɓ2 receptor
ndash prop4Ɓ2 the major receptor mediating nicotine addictionndash activates (~50 of max effect of nicotine) + blocks nicotine effectsndash reduces withdrawal symptoms while reducing rewarding
effects of nicotine from cigarette smokebull Varenicline pre-smoking cessation reduces smoking (CPD)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
Weeks 9ndash24Comparison ORV vs P 274Bupr vs P 189NRT vs P 181V vs NRT 152Bupr vs NRT 104V vs Bupr 145
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
Varenicline
Bupropion
NRT
Placebo
Overall (N= 8058)
4
45
39
37
NPC (N = 3984)
13
22
25
24
PC (N = 4074)
65
67
52
49
To resize chart data range drag lower right corner of range
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
Varenicline
Bupropion
NRT
Placebo
Weeks 9ndash12
38
261
264
137
Weeks 9ndash24
255
188
185
105
Weeks 9ndash12
292
193
204
114
Weeks 9ndash24
183
137
13
83
Weeks 9ndash12
335
226
234
125
Weeks 9ndash24
218
162
157
94
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Chart1
Varenicline
Bupropion
NRT
Placebo
38
261
264
137
255
188
185
105
292
193
204
114
183
137
13
83
335
226
234
125
218
162
157
94
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
Varenicline
Bupropion
NRT
Placebo
Overall (N= 8058)
4
45
39
37
NPC (N = 3984)
13
22
25
24
PC (N = 4074)
65
67
52
49
To resize chart data range drag lower right corner of range
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
Varenicline
Bupropion
NRT
Placebo
Weeks 9ndash12
38
261
264
137
Weeks 9ndash24
255
188
185
105
Weeks 9ndash12
292
193
204
114
Weeks 9ndash24
183
137
13
83
Weeks 9ndash12
335
226
234
125
Weeks 9ndash24
218
162
157
94
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash12
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Weeks 9ndash24
Sheet1
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
Varenicline
Bupropion
NRT
Placebo
Overall (N= 8058)
4
45
39
37
NPC (N = 3984)
13
22
25
24
PC (N = 4074)
65
67
52
49
To resize chart data range drag lower right corner of range
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
Varenicline
Bupropion
NRT
Placebo
Weeks 9ndash12
38
261
264
137
Weeks 9ndash24
255
188
185
105
Weeks 9ndash12
292
193
204
114
Weeks 9ndash24
183
137
13
83
Weeks 9ndash12
335
226
234
125
Weeks 9ndash24
218
162
157
94
59
EAGLES Primary NPS Composite Safety Endpoint
AEs reported during treatment and le30 days after last dose (All treated population) 1 additional participant (PCNRT group) +SI identified after clinical database lock and not included in the analysis
Cohort effect p lt 00001Treatment by cohort interaction p = 00650
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
Varenicline
Bupropion
NRT
Placebo
Overall (N= 8058)
4
45
39
37
NPC (N = 3984)
13
22
25
24
PC (N = 4074)
65
67
52
49
To resize chart data range drag lower right corner of range
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
Chart1
Varenicline
Bupropion
NRT
Placebo
Observed rate of event ()
4
45
39
37
13
22
25
24
65
67
52
49
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
Varenicline
Bupropion
NRT
Placebo
Overall (N= 8058)
4
45
39
37
NPC (N = 3984)
13
22
25
24
PC (N = 4074)
65
67
52
49
To resize chart data range drag lower right corner of range
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
Overall (N= 8058)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
NPC (N = 3984)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
PC (N = 4074)
Sheet1
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
Varenicline
Bupropion
NRT
Placebo
Overall (N= 8058)
4
45
39
37
NPC (N = 3984)
13
22
25
24
PC (N = 4074)
65
67
52
49
To resize chart data range drag lower right corner of range
60
Varenicline Quit ApproachesFIXED QUIT approachbull Set quit date for 1 wk after starting vareniclinebull Continue treatment for 12 wks
FLEXIBLE QUIT approachbull Start taking varenicline and pick a quit date
between 8 to 35 days from treatment initiationbull Continue treatment for 12 wks
GRADUAL QUIT approachbull Start taking varenicline and reduce smoking by
50 within the first 4 wks an additional 50 in the next 4 wks and continue until complete abstinence by 12 wks
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
61
EVIDENCE-BASED PHARMACOTHERAPYbull Most effective
bull Combination NRT [patch + short acting]bull Varenicline
bull Second linebull Bupropion (+- NRT)
bull Single form NRT
bull Other considerationsbull Most effective with behavior therapy
bull Extended pharmacotherapy ndash up to 1 yearbull Flexible quit date
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
62
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
63
Q What are the two most effective medication options for quitting smoking
A vareniclineB bupropionC nicotine inhalerD combination nicotine replacement
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
64
Varenicline is the best single form medication for quitting smokingCombining a long- (patch) + short-acting form of NRT (lozenge gum
inhaler nasal spray) is just as effective in treating tobacco use
While use of a single form of NRT also has evidence for supporting cessation combined use is recommended to ensure sufficient dosing of nicotine replacement and
to address break-through cravings Bupropion also has evidence for supporting cessation but is less effective than
varenicline and combination NRT
65
Medications in Developmentbull Cytisine - alkaloid extracted from seeds of Cytisus laburnum
ndash like varenicline a partial agonist at the prop4Ɓ2 nAChRndash significant effects relative to placebo
bull meta-analysis RR 174 95 CI 138 to 219)ndash superior to NRT in RCT paired with behavioral support
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
66
Q True or False
A TrueWhile counseling and medication are each independently
effective at increasing smoking cessation the combination of the two is even more effective
+
The combination of counseling and medication is more effective than either treatment alone
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
67
What About E-cigs
bull e-cigs e-hookah mods vape pens vapes tank systems Juul Suorin
Phix Rubi Vuse electronic nicotine delivery systems (ENDS)
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
68
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
69
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
bull Kaiser Permanante Northern California patients aged 12+ with at least one instance of documented ECIG use from 2012-2015 (N=8256)
bull AIM Examine change in smoking by ECIG use documented 12 mo priorbull Matched analyses comparing the subset of patients with documented
ECIG use (N=7926) and without documented ECIG use (N=7926)ndash Matched on age sex raceethnicity and smoking status
bull Smoking status was 57 current smokers 35 former and 8 never-smokers
Young-Wolff KC Klebaner D Folck B Fogelberg R Prochaska JJ (2018) Documentation of e-cigarette use and associations with smoking from 2012 to 2015 in an integrated healthcare delivery system Preventive Medicine 109 113-118
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
70
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
bull Among current smokers documented ECIG users had increased odds of quitting smoking
ndash OR=126 95 CI=113-140 plt0001
bull Among former smokers ECIG users had increased odds of relapsing to smoking
ndash OR=179 95 CI=145-221 plt0001
bull Among never-smokers ECIG users had elevated odds of becoming a smoker
ndash OR=817 95 CI=350-191 plt0001
23
14
8
19
7
1
Current Smokers Former Smokers Never Smokers
ECIG users ECIG nonusers
relapsed
quit
initiated
Young-Wolff et al 2018 Prev Med
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
71
Hajek et al 2019 NEJM
Among participants with 1-year abstinence 80 in ECIG group vs 9 in NRT group
still using the assigned products 52 wks
18 ECIG vs 10 NRT quit smoking at 52 wks
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
72
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
57
1215
202525
3562
65
Quitline
Website (Smokefreegov)
Bupropion or Chantix
Help from health prof
Switched to mild cig
Switched completely to Ecig
NRT
Subst Reg w Ecig
Reduced cigs
Quit Once
Caraballo et al 2017 PCD
1-800-QUIT-NOW Most quit attempts are ldquocold turkeyrdquo unaidedAttempts to switch to other tobacco products are commonFew use evidence-based treatments
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
73
Less than 4 of smokers in a given year succeed in remaining abstinent
34 MillionUS Adult Smokers 68
23 Million want to quit
5519 Million quit for gt 24 hrs
72 Million quit
6 mos out
lt 414 Million succeed
Milli
ons
Every day gt3000 12- to-17-year olds smoke their first cigarette and gt2000 become new daily smokers
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
Chart1
Series 1
40
272
2216
296
148
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
Smokers
Want to Quit
Quit for 24 hrs
Quit 6 mo
Succeed Long-term
Sheet1
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
Series 1
Smokers
40
Want to Quit
272
Quit for 24 hrs
2216
Quit 6 mo
296
Succeed Long-term
148
74
Q True or False
A FalseNearly 7 in 10 adults who try to quit smoking did not use
any evidence-based treatment in their quit attempt
Most adults who try to quit smoking report using evidence-based treatment to do so
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
75
bull N=173 adolescents using an ECIG at least once in the prior 30 days and 10+ lifetime uses
bull 75 male age M=166 yrs (SD=12 R 13-18) 55 Whbull At 12-month follow-up 80 continued to use ECIGsbull Daily use increased from 145 at baseline to 18 at 6-month
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
Evidence largely for daily smokingGAP Nondaily smokers
Evidence largely for cigarettesGAP Other tobacco products and dual users
Evidence Gaps
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
78
ConclusionsTreating tobacco use is relevant to all areas of medicine
Medications work alone and are maximized when paired with counseling
USPSTF ldquoGrade Ardquo recommendation for treating tobacco use
Mobile health solutions extend reach and have demonstrated efficacy
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
1
Patient cases - Tobacco Cessation Estela Lajthia PharmDClinical Assistant Professor of Pharmacy Practice Howard University College of Pharmacy
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
2
LETS PRACTICE
bull Objectives ndash Identify possible barriers and solutions using a patient centered
approachndash Apply the main concepts and approaches of tobacco cessation
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
3
CASE 1
bull TA is a 49 year old male with a history of smoking since the age of 22 He presents today to clinic seeking assistance with smoking cessation
bull Past medical history type 2 diabetes x7 years hyperlipidemia x8 years hypertension x8 years and coronary artery disease (sp an MI)
bull Family history father died of prostate cancer mother has heart disease and type 2 diabetes No siblings
bull Social history works as a mailman sedentary lifestyle drinks a six pack of beer 3-4 times a week divorced smokes 10 - 15 cigarettes a day cut down after his MI 5 years ago admits to poor adherence because he is ldquoon too many pillsrdquo
4
CASE 1 ndash CLINICAL PRESENTATIONbull Vital signs BP 13078 mmHg HR 78bpm BMI 342
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
Na 140 mEqL Cl 104 mEqLCO2 21mEqL BUN 13 mgdLK 42 mEqL SCr 102 mgdLAST 36 UL ALT 21 UL
Medication list Lisinopril ndash HCTZ 20-125mg dailyMetoprolol 50mg twice a dayAmlodipine 10mg dailyAspirin 81mg dailyAtorvastatin 40mg daily Metformin 1000mg twice dailySitagliptin 100mg dailyLantus 34 units daily
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
5
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often do you smoke
CVD benefits of quitting smoking
Readiness to quit Nicotine Dependence
OfferBehavioral support amp Treatment
If they accept follow up in 2-
4 weeks
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
6
CASE 1bull Ask TA smokes dailybull Advise CVD risks
ndash Extensive history of CVDndash Motivational interviewing
bull ldquoQuitting now is the best way to avoid another heart attackrdquo
bull AssessReadiness Smoking indexndash How many cigarettes do you
smoke bull 0 lt10bull 1 11-20bull 2 21-30
bull 3 gt30ndash How soon after waking up do you
smoke your first cigarette of the day
bull 0 after 60 minsbull 1 31 ndash 60minsbull 2 6-30 minsbull 3 within 5 mins
ndash Score 0-2 (low) 3-4 (moderate) 5-6 (high)
ndash TA has moderate nicotine dependence
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
7
CASE 1 - PLANAssistbull Behavioral supportbull Pharmacotherapy
ndash NRT vs Bupropion vs Vareniclinebull Medication adherence
ndash Drug - Drug interactionsbull Check
ndash Drug - Disease interactionsndash Side effects
bull Bupropion ndash weight gainndash Education on nicotine withdrawal
1st lineVarenicline or combination
NRT
2nd lineBupropion or
single NRT product
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
8
CASE 1 - PLAN
bull Arrangendash If patient accepts follow up via phone or office visit in 2-4 weeks
bull Monitor treatment response adherence and adverse events ndash If patient declines continue to engage and ask them to quit at
every visitbull Document
ndash E- prescribe
J Am Coll Cardiol 2018 Dec 72 (25) 3332-3365
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
9
CASE 2bull SB is 54 year old AA female with hypertension x11 years
hyperlipidemia x8 years arthritis x5 years presents to your clinic for routine visit
bull Family history father has hypertension and heart disease mother died of breast cancer 5 years ago
bull She started smoking at the age of 25 About 7 years ago she was able to quit ldquocold turkeyrdquo and was smoke free for 2 years Unfortunately she lost her mother in 2015 and relapsed She started smoking again to deal with the stress Currently smokes one pack a day not ready to quit at this time
bull Social history drinks alcohol socially married with two children denies use of illicit drugs recently lost her job
10
CASE 2 ndash CLINICAL PRESENTATION
bull Vitals from the visit BP 14282 mmHg HR 87 bpm BMI 295
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS
Nicotine Replacement Therapies (NRT)approx 1 cig = 1 mgtime to first cigarette upon wakening (lt 30m)combination NRT
Nicotine rdquoGumrdquo
Nicotine ldquoInhalerrdquo
Q What two items inform dosing of nicotine replacement therapy
Q What two items inform dosing of nicotine replacement therapy
Dosing of NRT
Bupropion
Varenicline
EAGLES TrialN=8144
EAGLES Primary NPS Composite Safety Endpoint
Slide Number 60
Evidence-based Pharmacotherapy
Q What are the two most effective medication options for quitting smoking
Q What are the two most effective medication options for quitting smoking
Slide Number 64
Medications in Development
Q True or False
What About E-cigs
Slide Number 68
CHANGE in EHR DOCUMENTED SMOKING STATUS by ECIG USE 2012-2015
CHANGE in SMOKING STATUS at 12-MO by ECIG USE
Hajek et al 2019 NEJM
US Adult Smokersrsquo Quit Methods 2014ndash16 (n=15943)
Less than 4 of smokers in a given year succeed in remaining abstinent
Q True or False
Slide Number 75
Slide Number 76
Slide Number 77
Conclusions
13
CASE 3bull EP is a 31 year old male who used to smoke cigarettes socially on
weekends while in college Later on he switched to e-cigarettes thinking it was a ldquobetter choicerdquo Now five years later he thinks he is addicted to e-cigarettes and wants to quit
bull Past medical history not significantbull Family history mother has Crohnrsquos disease father has hypertension
and vitamin D deficiency bull Social history consumes 4-5 drinks on weekends occasional use of
marijuana single works as an accountant
14
APPROACH
ASK ADVISE ASSESS ASSIST ARRANGE
How often are you smoking
Risks of e-cigarettes
Readiness to quit
OfferBehavioral
support
If they accept follow up in 2-
4 weeks
15
CASE 3 - PLAN
bull Askbull Advise
ndash E- cigarettes contain additional chemicals to nicotine (risk)
ndash E- cigarettes vs combustible cigarettes
ndash No long term databull Assess how often and for how
long
bull Assistndash Behavioral
bull Make a plan to taper down
bull Set goalsndash Pharmacotherapy
bull NRT off label bull Arrange
Tobacco Cessation
A Message from US Surgeon General Jerome Adams
DISCLOSURES
Learning Objectives
Overview
Overview
Tobacco Products
E-cigarette Evolution
FORMS of TOBACCO SUMMARY
US ADULT SMOKING by SEX 1955ndash2018
Cigarette SMOKING PREVALENCE BY CENSUS TRACK
Slide Number 12
Slide Number 13
Q True or False
Youth Tobacco Use Patterns NYTS 2019
Slide Number 16
FDA Ecig Flavor Restriction
Slide Number 18
NEUROCHEMICAL and RELATED EFFECTS of NICOTINE
NICOTINE WITHDRAWAL EFFECTS
What is Addiction
2020 ICD-10-CM Diagnosis Codes
NICOTINE ADDICTION SUMMARY
HEALTH CONSEQUENCES of SMOKING
Slide Number 25
E-cig Aerosol may Contain
E-cigarette or Vaping use-Associated Lung Injury (EVALI)
