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ADEPT and PRINCESSSmoking cessation strategies to reduce the
prevalence of cigarette smoking and smoking related harm
8th Addiction Research SymposiumDr Joanna Chu, Professor Chris Bullen, Associate Professor Natalie
Walker
Background
• Smoking is the leading cause of preventable diseases.
• The New Zealand Government has set a goal so that by 2025 fewer than 5% of New Zealanders will be smokers.
• Effective smoking cessation strategies are needed for reducing the prevalence of cigarette smoking and smoking-related harm.
How do we increase cessation?
• Getting rid of tobacco is unlikely, so:• Increase the price of cigarettes• Make safer sources of inhaled nicotine more
accessible and cheaper• Reduce nicotine content to very low levels
PRINCESSPreferences for Reduced Nicotine Cigarettes in
Smokers
Background
• Increasing attention has been given to the concept of very low nicotine content (VLNC) cigarettes as a mean to help individuals quit smoking or reduce the harm from smoking.
• Levels of nicotine so low as to have negligible or no central effects, provide behavioural and sensory replacement
VLNC - Evidence
• Health Promotion Agency (2016) reported that adults (n=2,594) showed wide support (81% of those surveyed, 63% of smokers, and all age, sex and ethnicity groups) for the concept that "nicotine content of cigarettes should be reduced to very low levels so that they are less addictive”.
VLNC - Evidence
• A pragmatic community-based randomised trial (n=1,410) in NZ showed that the combined use of VLNC cigarettes and NRT increases both short term and long term quit rates over NRT alone, in smokers motivated to quit (Walker et al., 2010)
• A randomised trial within the USA with 780 smokers unmotivated to quit. Those randomised to smoke very low VLNC rather than standard-nicotine cigarettes reduced their nicotine exposure, nicotine dependency, and cigarettes per day (Donny et al., 2015)
VLNC - Evidence
• VLNC cigs have also been shown to: – Be satisfying at least over the initial few days of
abstinence from smoking (Pickworth 1999; Rose 2000; Donny 2007)
– Reduce withdrawal symptoms, including urges to smoke and low mood (Rose 2000; Donny 2009; Barrett 2010; Perkins 2010)
– Lead to minimal compensatory smoking (Benowitz2012)
– Reduce self-reported levels of dependence (Hatsukami 2010)
– Can delay relapse back to smoking (Walker 2012)
Rationale
• The viability of VLNC as a smoking cessation strategy hinges in part on their acceptability and the willingness of smokers to use them.
• Although studies found that users reduced their total number of cigarettes smoked, smoking satisfaction appeared low, with smokers disliking the taste of the VLNC.
PRINCESS
• To assess the acceptability, psychological reward, craving reduction, and physical and sensory effects experienced when smoking a newly reformulated brand of VLNC cigarette, in comparison to smoking a previously developed brand of VLNC cigarette.
• A double-blind randomised cross-over study.• Sample size = 32 participants will be required
to detect a difference in satisfaction scores between the treatments of at least 0.5 points on a 7-point scale.
PRINCESS – Study DesignScreening and eligibility
Phone screening form (Form A)
Randomisation to Group 1 or Group 2Complete baseline evaluation (Form B)
Outcome assessment 1Smoke own cigarette
Complete cigarette evaluation (Form C1)45 minute washout
Outcome assessment 2AComplete cigarette evaluation (Form C2)
45 minute washout
Group 1 (n = 16)Smoke MAGIC 0
VLN cigarette (labelled ‘A’)
Group 2 (n = 16)Smoke MAGIC
VLN cigarette (labelled ‘A’)
Group 1 (n = 16)Smoke MAGIC
VLN cigarette (labelled ‘B’)
Group 2 (n = 16)Smoke MAGIC 0
VLN cigarette (labelled ‘B’)
Outcome assessment 2BComplete cigarette evaluation (Form C3)
Primary Outcome
• Smoking satisfaction domain from the mCEQ– Was smoking satisfying? – Did the cigarettes taste good? – Did you enjoy smoking?
Secondary Outcome
• Psychological Reward• Craving reduction• Respiratory tract sensations• Negative effects• Characteristics of the cigarette smoke• Intention to use
Participants wanted:
We are inviting people who are regular smokers of tobacco cigarettes to find out their views towards cigarettes that have been made with a very low nicotine content. Are you:
• a daily smoker of non-menthol tobacco cigarettes for more than 12 months?
• willing to attend the study site for the duration of the study?
• at least 18 years of age?
• have your first cigarette within 30 minutes of waking each morning?
• in good health?
• able to read and write English?
If so, you may be eligible to take part – so we are keen to hear from you. In appreciation of your time, cost of transport and effort, you will be reimbursed $50 petrol voucher after completing the study.
To join the study or find out more please Call/ txt on 021 148 5013, or email [email protected] by the University of Auckland Human Participants Ethics Committee on 03/04/2017 for three years. Reference Number 018902
Food for thought …
• Should NZ consider a nicotine reduction strategy?
ADEPTSupporting smokers to remain abstinent after hospital discharge using an automated digital
support package
ADEPT - Background
• Hospital admission provides a unique opportunity to offer support to smokers to quit.
• In the 3rd quarter of 2015/2016, 93% hospitalised smokers were identified and received brief advice.
• However, New Zealand hospitals provide limited follow-up support after discharge that research shows to be essential to sustained abstinence.
ADEPT - Background
• A Cochrane review and meta-analysis of 50 randomised controlled trials (RCTs) of cessation support for hospitalised smokers found sustained smoking cessation rates at six months following hospital discharge are higher only if the support provided during the hospital stay is followed up by contact for at least one month post-discharge, compared with those not given follow-up (risk ratio [RR] 1.37, 95% confidence interval (CI) 1.27-1.48).
ADEPT - Background
• Sustaining smoking cessation support after hospital discharge is a challenge for healthcare systems (i.e., limited resources and time consuming).
• A need to design innovative tools and/or resources that can be easily implemented and sustained.
ADEPT - Background
• Text messaging, or short message service (SMS), has been the most widely used mobile phone intervention.
• Two systematic reviews support the effectiveness of SMS interventions across a range of risk behaviours (such as smoking) and chronic conditions (such as diabetes and asthma).
• A large RCT (n=5800) published in the Lancet, showed a doubling of smoking quit rates at 6 months for those who received a SMS smoking cessation intervention (10·7% txt2stop vs 4·9% control, p<0·0001).
ADEPT
• We assess the effectiveness of a mHealthintervention (ADEPT – an automated package of digital therapies) for hospital discharged patients on smoking cessation rates compared with usual care.
• Sample size, n=268 (134 participants in each group).
• Hypotheses:– Patients offered support using ADEPT, delivered daily
over 4 weeks post-discharge as well as access to usual care (inpatient counselling and NRT prescription) will lead to increased quitting rates at one and three months compared with usual care.
ADEPT – Study Design
OUTCOME ASSESSMENTOutcomes measured at one, and three months
7-day point prevalence abstinence rates Continuous abstinence rates (self-reported)Current smoking details, if still smokingTime to relapse back to smoking tobaccoUse of other cessation therapies Perceptions of acceptability of the intervention through exit interviews with
intervention participants. Engagement of the intervention (number of messages read, and number of
participant contacts to study team) through exit interviews.
ADEPT INTERVENTION GROUP (4 Weeks Duration)
- Care-as usual PLUS- text registration sheet
- Receipt of intervention digital package
CONTROL GROUPReceive Care-as-usual services
Research Nurse/Assistant identify and invite potential participants into study. Explains
study, obtains informed consent, and conducts baseline assessments. Forms B, E, Z
RANDOMISATION
Control – Care-as-usual
• Participants in the control arm will receive usual care.
• When patients are admitted their smoking status is routinely recorded, and if they are a smoker, a health worker will give them brief advice to quit smoking and issue them a ‘quitcard’ (an exchange voucher for subsidised nicotine replacement therapy [NRT]), and refer them for support via Quitline or a hospital cessation counsellor.
Intervention
• In addition to usual care, all intervention participants will receive a tailored programme of text messages (SMS) via their mobile phone.
• Delivered over 4 weeks, participants will be sent regular messages providing smoking cessation advice and support (e.g. symptoms to expect on quitting, tips to cope with craving, advice on avoiding smoking triggers). – Participant will receive 3 messages per day for the first
week after discharge from hospital– 1 message per day for the second week– 2-3 messages per week for the remaining two weeks
Sample Text MessagesLabel Text Message Content
Upon registration Welcome text Hi {name}, welcome to the program! Just to let you know what to expect from us - quit tips, craving tips, inspiration, and encouragement
Day 1 -Upon discharge
Introduction Hi {name}, glad to see you recovering. Stay healthy and smoke free!
Day 1 Craving tips Keeping busy is important when a craving hits. Have things ready to do with your hands, e.g., play with a stress ball
Day 1 Encouragement Don’t look @ quitting as giving something up, what u r really doing is throwing away pure garbage that doesn’t belong in yr life anymore
Day 2 Craving Tips In 2 minutes the crave will pass-keep positive, focus on the pride you’ll feel in 3 minutes for beating the crave
Day 2 Reason Work out why you want to quit. You might be tired of being controlled, tired of the costs, tired of feeling tired & unwell. Write it down
Day 2 Quit tips If you've tried to quit before, think about what helped, what didn't, why did you started again. Write this down as part of your quit plan
Day 3 Inspiration One of the greatest of all principles is that people can do what they think they can do. Believe u can do it.
Day 3 Reason Make a list of reasons why you want to quit + carry it with you. When a craving hits, pull it out to give you a motivation burst
Day 3 Quit tips Don't feel lonely, there are many people going through the same thing. Need support? Call quitline 0800778778
Day 4 Inspiration See yourself as a non smoker. When offered a cig say, no I'm quitting. I bet the other person will say 'Good on you, I wish I could'
Day 4 Quit tips Don't carry cigarettes, tobacco, papers or lighters with you. Sounds basic but if you don't have them you cant smoke them!
Day 4 Inspiration The awful truth: Smokers die about 14 years before their non-smoking friends. Reduce your risk -butt out!
Primary Outcome
• Three months continuous abstinence (Russell Standard) defined as self-report of smoking not more than five cigarettes from the quit date. Sub group analysis by Māori/non-Māori will be undertaken to test for heterogeneity of effect.
Secondary Outcome
• 7-day point prevalence assessed• Continuous abstinence assessed at one and three months• Number of cigarettes smoked per day (or when smoking for
non-daily smokers): If the participant is still smoking, all time points.• Time-to-relapse from quit date, defined as return to daily
smoking (for daily smokers).• The physical signs and symptoms associated with withdrawal:
Measured using the MPSS.
• Use of any other smoking cessation methods• Perceptions of acceptability of the intervention through exit interviews
with intervention participants. • Engagement of the intervention (number of messages read, and
number of participant contacts to study team) through exit interviews.
Participants wanted:
We are inviting people who are regular smokers of tobacco cigarettes to find out their views towards cigarettes that have been made with a very low nicotine content. Are you:
• a daily smoker of non-menthol tobacco cigarettes for more than 12 months?
• willing to attend the study site for the duration of the study?
• at least 18 years of age?
• have your first cigarette within 30 minutes of waking each morning?
• in good health?
• able to read and write English?
If so, you may be eligible to take part – so we are keen to hear from you. In appreciation of your time, cost of transport and effort, you will be reimbursed $50 petrol voucher after completing the study.
To join the study or find out more please Call/ txt on 021 148 5013, or email [email protected] by the University of Auckland Human Participants Ethics Committee on 03/04/2017 for three years. Reference Number 018902
