SMOKELESS TOBACCO CESSATION

Dr. Aswini Y Balappanavar Assistant Professor

Department of Public Health Dentistry Maulana Azad Institute of Dental Sciences

New Delhi phdaswini@gmail.com

TOBACCO CESSATION CLINIC MAULANA AZAD INSTITUTE OF DENTAL SCIENCES

NEW DELHI tccmaids@gmail.com

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Contents

■  Back ground ■  Rationale for Smokeless Tobacco Cessation ■  Smokeless Tobacco Cessation ■  Strength of Evidence ■  Research gaps ■  Recommendations ■  Conclusions

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Background

Physical Psychological Economical

Environmental

GATS SURVEY 2017 -http://www.searo.who.int/india/mediacentre/events/2017/gats2_india.pdf?ua=1 11/27/2017 Dr. Aswini Y B 4

Background

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Dependence treatment – Rationale

•  90 % of the SLT users - tried unsuccessfully to quit on their own at least once, •  25 % - > 6 unsuccessful quit attempts,

•  10 % - > 10 times. •  (Hatsukami DK, Severson HH, NTR 1999)

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Dependence treatment – Rationale

■  SMOKING CESSATION POLICIES – unintentional push towards smokeless tobacco use.

■  CHEAPER ALTERNATIVE & EASY AVAILABILITY.

■  HARM REDUCTION – marketed and manufactured by tobacco companies.

■  9 FOLD INCREASE (1991 to 2010) - Rs 181 million to Rs 1,648 million.

■  ONE IN TEN STUDENTS (13–15 years) – SLT usage (GYTS, 2009)

■  70 million WOMEN age 15 and older use SLT.

■  TAXATION FAILS – very low unit prices.

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Dependence treatment – Rationale ■  Smokeless tobacco use GATEWAY for cigarette smoking in young

males. (233%) (Haddock CK, Weg MV, DeBon M, et al. 2001)

SLT - 3.4 mg/gm ((range 2.6-4.1 mg/gm) Cigarettes - 15 mg/gm

Bidis - 26.9 mg/gm (Sujatha S Reddy, Shaik Hyder Ali KH 2008)

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A Global Solution to a Global Epidemic

Image sources: (left) World Health Organization. (2000). Geneva public hearing; (right) World Health Organization. (2011). Image source: World Health Organization. (2008). WHO Report on the Global Tobacco Epidemic, 2008. www.who.int/tobacco/mpower/2008/en/index.html 11/27/2017 Dr. Aswini Y B 9

Tobacco Use Cessation Clinical Interventions for Tobacco Users

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Model for treatment of tobacco use and dependence

Tobacco Dependence Treatment Guidelines. National Tobacco Control Programme, Ministry of Health & Family Welfare Government of India, 2011 11/27/2017 Dr. Aswini Y B 11

BEHAVIORAL INTERVENTIONS Tobacco Dependence Treatment Guidelines. National Tobacco Control Programme, Ministry of Health & Family Welfare Government of India, 2011 11/27/2017 Dr. Aswini Y B 12

Stages of change model & 5 R`S

Tobacco Dependence Treatment Guidelines. National Tobacco Control Programme, Ministry of Health & Family Welfare Government of India, 2011 11/27/2017 Dr. Aswini Y B 13

Dependence scales

Smokeless Tobacco Dependence Scale (STDS).

Fagerström Test for Nicotine Dependence (FTND)

The Nicotine Dependence Syndrome Scale (NDSS).

Fagerström Tolerance Questionnaire for Smokeless Tobacco (FTQ-ST) users

The Severson Smokeless Tobacco Dependency Scale (SSTDS)

The Glover-Nilsson Smokeless Tobacco Behavioral Questionnaire (GN-STBQ).

Mina Rydell et al 2015, Sharma MK, Sharma P. 2016, Jon O. Ebbert et al 2007 & 2013, Amy K. Ferketich et al 2008

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Investigations PE

RSON

ALIZ

ED F

EED

BACK

BIOMARKERS OF TOBACCO USAGE (Cotinine , CO)

DISEASE RISK (Cancer Susceptibility By Genotyping)

TOBACCO RELATED HARM (Atlerosclerotic plaque, Blood sugar levels etc)

Raphaël Bize 2007

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Pharmacotherapy

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QUITLINES

■  1800-11-2356 – 40%

■  Counseling

■  Follow up reminders & Missed appointments

■  Relapse Prevention

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Barriers

■  Clinicians lack knowledge & Limited training .

■  Inadequate support for routine assessment and treatment of tobacco use.

■  Time constraints in tobacco cessation interventions.

■  Lack of insurance coverage for tobacco use treatment.

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PROFESSIONAL CONSUMER

■  Low Awareness

■  Never considered as a problem

■  Lack of Awareness and Access to Cessation Clinics

■  Stigma Associated as many clinics in Psychiatry Dept.

■  Lack of Motivation as need quick fix solutions

EVIDENCE – PREVIOUS REVIEWS 1

Hatsukami and Boyle (1997) Evidence base is limited by small sample sizes and lack of control groups

2

Ebbert et al. (2007) A Cochrane review www.thecochranelibrary.com

Behavioral treatments may help people stop using ST

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Evidence – Cochrane review (2015)

■  34 randomized controlled trials enrolling more than 16,000 smokeless tobacco (ST) users

■  16 trials evaluated pharmacotherapy & 17 Trails evaluated Behavioural interventions.

■  Schools, Institutes and Workplace

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Conclusion : •  Varenicline, Nicotine Lozenges and Behavioral Interventions may help ST users to quit.

•  Confidence in the size of effect from behavioral interventions is limited because the components of behavioral interventions that contribute to their impact are not clear.

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TELEPHONE AND ORAL EXAMINATION

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TELEPHONE AND ORAL EXAMINATION

■  TELEPHONE ONLY (RR- 1.66)

■  ORAL EXAMINATION ONLY

(RR – 1.01)

■  NO TELEPHONE AND NO ORAL

(RR- 1.22)

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Nicotine Replacement Therapy (NRT)

■  12 Trials - suggested a s t a t i s t i c a l l y s i g n i fi c a n t t reatment ef fect , which appears to be driven by the efficacy of the nicot ine lozenge.

■  There is low evidence to support the use of nicotine gum or patch.

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BEHAVIORAL + NRT

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ABRUPT VS GRADUAL REDUCTION

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Bupropion Evidence for the effect of bupropion SR for the treatment of ST use is inconclusive.

■  PREVIOUS REVIEW :

Bupropion SR is effective for:

1.  Decreasing craving

2.  Attenuating weight gain

Bupropion SR is not effective for

1.  Increasing long-term ST abstinence rates ,

2.  Decreasing withdrawal symptoms

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Varenicline

■  Moderate quality evidence

■  Increases long term ST abstinence rates by 34% compared to placebo among ST users..

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INDIAN SCENARIO

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Delhi - smokeless tobacco users (94%) BI group were twice more likely to stop tobacco use as compared to individuals in the SA group (odds ratio = 2.2, 95% confidence interval: 0.962-5.197, P = 0.06). 40.8% Vs 27.7 - 3 month self reported abstinence rate

A Randomized Pilot Study of Brief Intervention versus Simple Advice for Women Tobacco Users in an Urban Community in India – Sonali Jhanjee et al 2017

N=237 there were no differences between placebo and varenicline participants in measures of withdrawal, craving, or affect from baseline to week 3 or at EOT. 42.9% vs. 30.5% - 3 month quit PPR

Evaluating the Effects of Varenicline on Craving, Withdrawal, and Af fect in a Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Varenicline for Smokeless Tobacco Dependence in India. Sonali Jhanjee et al 2015

Varenicline is safe for treating smokeless tobacco dependence in India, and further examination of this medication for this important public health problem is warranted.

A double-blind placebo-controlled randomized trial of varenicline for smokeless tobacco dependence in India. Jain R et al 2014

Biochemical Validation of Self-Reported Smokeless Tobacco Abstinence among Smokeless Tobacco

Users: Results from a Clinical Trial of Varenicline in- India. Jain R et al 2015 =

Poor agreement between self-reported and biochemically confirmed abstinence (κ = -0.191). 

ABSTINENCE and RELAPSE RATE

■  27% at 6 month & 52% among Tuberculosis patients. (Deepak KG et al 2012)

■  27- 80% quit rates in various studies .

■  50-60% relapse rates

Thomas M.D et al (2001), Boyle (1992, 2004, 2008), Cigrang (2002), Cummings (1995), Dale (2002, 2007), Sonali et al (2016), Danaher (2013, 2015), Ebbert (2007, 2009, 2011, 2013), Fagerstrom (2010), Schiller (2012), Severson (2007,2008, 2009, 2015)

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TCC MAIDS - Experience TOBACCO RELATED FACTORS

SMOKE TOBACCO (n=245)

SMOKELESS TOBACCO (n=385)

DUAL TOBACCO USERS (n=70)

NICOTINE DEPENDANCE (Mean +SD)

4.6+2.4 (FTND SCORE) 6.2+1.6 (Modified FTQ) 3.8+2.6 (S); 5.4+2.4 (SLT)

r=-0.325** p<0.01

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  No. of years of SLT use Expense No. of Pouch

FTQ score 0.123* 0.137* 0.299**

Results of Correlational analysis for SLT users

**=p<0.001, *=p<0.05

Tobacco Types Nicotine Dependence n (mean+ SD)

 

Smoke Less Tobacco

Gutkha 112 (6.2+1.5)

Khaini 188 (6.3+1.5)

Pan/Gul 77 (6.08+1.9)

Multiple user 8 (5.8+1.1)

  P=0.50

Smoke Form Beedi 153 (5.0+2.2)

Cigarette 92 (4.1+2.5)

  P=0.006**

Tobacco Dependence as a chronic disease?????

Clinicians and health care systems often fail to treat tobacco use consistently

and effectively.

Use of medication is low

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Research Gaps /Knowledge Gaps ■  Lack of high-quality RCTs - short and long-term benefits

■  More research is needed to identify the characteristics of the most effective interventions, including factors such as the:

–  Type of advice provided –  Duration of the intervention –  Type of provider –  Contact time needed –  Follow up & Adherence

■  Assess the benefits and harms of interventions in at risk populations

■  Questionnaires for assessing nicotine dependence – not validated in India.

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Research Gaps /Knowledge Gaps ■  Psychosocial, Cultural and Genetic Variables.

■  Biomedical Risk Assessment.

■  Special groups or Risk Groups.

■  Training and Curriculum Development Modules – Validation

■  Indigenous systems – Acupuncture, Yoga, Spirituality etc

■  Substitutes for Smokeless Tobacco -(Mint snuff substitute • Chewing gum • Hard

candy • Sunflower seeds • Beef jerky • Herbal chews • Toothpicks • Cinnamon sticks

• Coconut snuff substitute)

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(Hatsukami et al 2003, McChargue et al 2002, Zavela et al 1995, Hatsukami et al 2008)

Research Gaps /Knowledge Gaps

■  New legislative and regulatory mandates which can be used to increase the rates of delivery of tobacco use treatment in healthcare settings (e.g., both via incentives and penalties).

■  Cost-effectiveness and cost-per-quit of tobacco use treatment have not been extensively examined in real world settings.

■  Mobile and emerging technology (eHealth, mHealth, social media, short message service (SMS), interactive voice recording [IVR], virtual social networks) strategies and resources be used to increase the demand and reach of evidence-based treatments

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Tobacco Control Research Priorities for the Next Decade: Working Group Recommendations for 2016 – 2025. Report of the Tobacco Control Research Priorities Working Group of the NCI Board of Scientific Advisors , 2016

Recommendations ■  Extending or offering evidence-based tobacco use treatments to broader, higher prevalence

populations.

■  Increasing SLT user demand for evidence-based treatments.

■  Expanding the reach of effective treatments.

■  Improving treatment delivery, implementation, and sustainability.

■  "Institutionalizing" or creating system-wide integration of evidence-based treatments into healthcare.

■  Leveraging technological advances to expanding the population-wide reach of evidence-based treatments.

■  Improving the successful translation of evidence-based treatment (i.e., its reach, demand, and quality).

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Implementation Considerations

Health in all policy (NTCP, NOHP NCCP etc)

Manpower (Health &Allied Health Professionals)

Infrastructure (Medical and Dental Institutes )

Tobacco Cessation Clinics

Population Based/ Community/Risk based Strategies

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Conclusions: Key Points

■  Behavioural interventions, Telephone, Oral Examination.

■  Varenicline , NRT Lozenges.

■  Behavioural interventions + NRT Gums.

■  For adult ST users, dental office interventions and clinic interventions involving multiple sessions and counselor support have been shown to be effective treatments, although most studies have been conducted in high-income countries.

■  Public awareness and understanding of the detrimental health effects of ST use is incomplete and extremely limited.

■  More research -develop specific ST intervention programs.

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New Challenges - Changing Tobacco

•  Nicotine Candies

•  Nicotine Lollipops

•  Lip Balms

•  Nicotine Water

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Pratima Murthy et al. Asian Jl Psych (Article in press)

Thank you

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