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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]

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