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Effectiveness and safety of nicotine patches combined with e-cigarettes (with and without nicotine) for smoking cessation: study protocol for a randomised controlled trial.

ABSTRACT: INTRODUCTION:Evidence indicates e-cigarettes can help people quit smoking; however, more confirmatory trials are needed. To date, no trials have evaluated the effectiveness and safety of combining nicotine patches with e-cigarettes (with and without nicotine) for smoking cessation. METHODS AND ANALYSIS:This study is a pragmatic, three-arm, community-based, single-blind, randomised trial undertaken in New Zealand. Eligible participants are daily/non-daily smokers, aged ?18 years, naive e-cigarette users and motivated to quit smoking in the next 2?weeks. Participants (n=1809), recruited using multi-media advertising, are randomised to 14 weeks of (1) 21?mg nicotine patches (n=201); (2) 21?mg nicotine patches+18?mg/mL nicotine e-cigarette (n=804); or (3) 21?mg nicotine patches+nicotine?free e-cigarette (n=804). Participants receive weekly withdrawal-oriented behavioural support calls for 6?weeks post-randomisation. The primary outcome is self-reported biochemically verified continuous abstinence (CA) at 6?months post quit-date. The primary comparison is nicotine patch + nicotine?e-cigarette versus nicotine patch + nicotine?free e-cigarette, and the secondary comparison is nicotine patch versus nicotine patch +nicotine?e-cigarette (90% power, p=0.05, to detect an absolute difference in 6?month CA rates of 8% and 15% respectively). Secondary outcomes, collected by phone interview at quit date, then 1, 3, 6 and 12 months post-quit date, include self-reported CA, 7?day point prevalence abstinence, cigarettes per day (if smoking, or when smoking for non-daily smokers), time to relapse (if returned to smoking), belief in ability to quit, use of other cessation support, side effects/serious adverse events, treatment compliance, seeking additional support around e-cigarette use, daily use of both e-cigarettes and cigarettes, use of treatment past 14 weeks, views on treatment and recommendation to others, weight and cost-per-quitter. ETHICS AND DISSEMINATION:The Northern A Health and Disability Ethics Committee approved the trial. Findings will be disseminated through publication, conference/meeting presentations, and media. TRIAL REGISTRATION NUMBER:NCT02521662; Pre-results.

SUBMITTER: Walker N

PROVIDER: S-EPMC6398670 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Effectiveness and safety of nicotine patches combined with e-cigarettes (with and without nicotine) for smoking cessation: study protocol for a randomised controlled trial.

Walker Natalie N Verbiest Marjolein M Kurdziel Tomasz T Laking George G Laugesen Murray M Parag Varsha V Bullen Chris C

BMJ open 20190225 2

<h4>Introduction</h4>Evidence indicates e-cigarettes can help people quit smoking; however, more confirmatory trials are needed. To date, no trials have evaluated the effectiveness and safety of combining nicotine patches with e-cigarettes (with and without nicotine) for smoking cessation.<h4>Methods and analysis</h4>This study is a pragmatic, three-arm, community-based, single-blind, randomised trial undertaken in New Zealand. Eligible participants are daily/non-daily smokers, aged ≥18 years, n ...[more]

PMID: 30808668

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Project description:BackgroundSmoking rates are higher in New Zealand (NZ) adults with mental illnesses and alcohol and other drug (AOD) addictions, compared to the overall population. Quit attempts using "gold standard" smoking cessation treatments often fail in people with these conditions, so more flexible treatment regimens that adapt to a person's responsiveness to treatment are worth investigating. The STATUS trial aims to evaluate the effectiveness and safety of combining varenicline with nicotine e-cigarettes for smoking cessation among varenicline non-responders in treatment for mental health illnesses and/or AOD addictions.MethodsThis is a pragmatic two-arm, open-label, randomised trial. Participants will be daily smokers using mental health and/or addiction services in Auckland, aged ≥18 years, motivated to quit smoking, and eligible to access varenicline through the NZ special authority process. After 2 weeks of using varenicline plus behavioural support, participants who have not reduced their daily smoking by ≥50% will be randomised (1:1) to either 10 weeks of continued varenicline use or 10 weeks of varenicline plus an 18 mg/mL nicotine e-cigarette. All participants will receive weekly withdrawal-orientated behavioural support calls for 6 weeks post-randomisation. The primary outcome is self-reported biochemically-verified (exhaled carbon monoxide) continuous abstinence at 24 weeks post-randomisation. Secondary outcomes, measured at six, 12 and 24 weeks post-randomisation include: self-reported continuous abstinence, 7-day point prevalence abstinence, smoking reduction, time to relapse, cross-over, use of other smoking cessation support, serious adverse events, treatment adherence, compliance, acceptability, dual use, continuation of treatment use, mental illness symptoms and AOD use, health-related quality of life, and cost-analysis. A sample size of 338 will confer 80% power (p = 0.05) to detect a 15% absolute difference between the varenicline alone and varenicline plus e-cigarette groups.DiscussionPeople with mental illness and/or AOD addictions are just as motivated as others to quit smoking, but are less likely to succeed. Adapting smoking cessation medication after a lack of responsiveness in the first 2 weeks of initial treatment in this priority population by adding a nicotine e-cigarette may be one way to increase long-term quit rates.Trial registrationAustralian NZ Clinical Trial Registry: ACTRN12616001355460 (29 September 2016).

Project description:Background The success of pharmacotherapies for smoking cessation in real-life remains limited, with a significant number of long-term relapses. Despite first promising results, the duration of the effectiveness of electronic cigarettes is still unknown. Our objective was to assess the duration of the effectiveness of electronic cigarettes on smoking cessation and reduction in daily smokers. Methods The databases EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), ClinicalTrials.gov and PUBMED were consulted until March 23, 2022. We selected only randomized controlled trials with daily adult smokers. The intervention was the nicotinic electronic cigarette vs. non-nicotine electronic cigarette or other validated pharmacotherapies (varenicline, bupropion and nicotine replacement therapy). The minimum duration of the intervention was 3 months, with a follow-up of at least 6 months. Two independent reviewers used the PRISMA guidelines. The primary endpoint was smoking cessation at the end of the intervention and follow-up periods confirmed by a reduction in expired CO < 10 ppm. The reduction was defined as at least 50% of the initial consumption or by a decrease of daily mean cigarette consumption at the end of the intervention and follow-up periods. Results Abstinence at the end of the intervention and follow-up periods was significantly higher in the nicotine electronic cigarette group, compared to nicotine replacement therapy (NRT) [respectively: RR: 1.37 (CI 95%: 1.32–2.93) and RR: 1.49 (CI 95%: 1.14–1.95)] and to the non-nicotine electronic cigarette condition [respectively: RR: 1.97 (CI 95%: 1.18–2.68) and RR: 1.66 (CI 95%: 1.01–2.73)]. With regard to smoking reduction, the electronic cigarette with nicotine is significantly more effective than NRT at the end of the intervention and follow-up periods [respectively RR: 1.48 (CI 95%: 1.04–2.10) and RR: 1.47 (CI 95%: 1.18–1.82)] and non-nicotine electronic cigarette in the long term [RR: 1.31 (CI 95%: 1.02–1.68)]. Conclusions This meta-analysis shows the duration of the effectiveness of the nicotine electronic cigarette vs. non-nicotine electronic cigarette and NRT on smoking cessation and reduction. There are still uncertainties about the risks of its long-term use and its potential role as a gateway into smoking, particularly among young people.

Project description:Some smokers may benefit from a therapy that combines different nicotine replacement therapies (NRT) or drugs with different mechanisms of action.The aim of this study was to determine the efficacy of the combined therapy of varenicline and nicotine patches versus varenicline monotherapy.Three hundred forty-one smokers who smoked 20 or more cigarettes per day were recruited from a smoking cessation clinic between February 2012 and June 2013. The participants were randomized to receive a varenicline plus nicotine patch of 21 mg every 24 hours (170) or varenicline plus a placebo patch (171). All of the smokers received a standard 12-week course of varenicline and an 11-week course of either the placebo patch or the active patch after the target quit day. Both groups received behavioral support. The primary outcome was continuous abstinence for weeks 2 through 12 confirmed by exhaled levels of carbon monoxide. Post hoc subgroup analyses were performed to evaluate the treatment effects for a specific endpoint in subgroups of smokers.The combination of the nicotine patch with varenicline was not associated with higher rates of continuous abstinence at 12 weeks (39.1% versus 31.8%; odds ratio (OR) 1.24; 95% confidence interval (CI) 0.8 to 2.6) and 24 weeks (32.8% versus 28.2%; OR 1.17; 95% CI 0.4 to 1.9). When participants were analyzed by subgroups according to cigarette consumption, the abstinence rates among smokers who smoked more than 29 cigarettes per day at 12 weeks (OR 1.39; 95% CI 1.2 to 2.5) and 24 weeks (OR 1.46; 95% CI 1.2 to 2.8) were significantly higher in the combination group. Other post hoc analyses based on level of dependence and previous quit attempts did not show subgroup differences. No differences between the groups for the reported adverse events were observed (?2 value 0.07; P 0.79).The combination of varenicline with the nicotine patch does not improve abstinence rates at 12 and 24 weeks compared with varenicline used as monotherapy when all smokers were analyzed as a whole, independent of consumption level.This study is registered at clinicaltrial.gov (NCT01538394).

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Effectiveness and safety of nicotine patches combined with e-cigarettes (with and without nicotine) for smoking cessation: study protocol for a randomised controlled trial.

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Effectiveness and safety of nicotine patches combined with e-cigarettes (with and without nicotine) for smoking cessation: study protocol for a randomised controlled trial.

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