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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.
- electronic cigarettes
- e-cigarettes
- cessation
- nicotine patch
- effectiveness
- safety
- randomised controlled trial
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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Footnotes
Contributors Authorship follows the ICMJE guidelines. NW, VP, GL, ML and CB conceived the original idea for the trial, sought and obtained funding for the trial and wrote the study protocol. TK is the project manager responsible for the day-to-day running of the trial, while MV is the research fellow involved in the trial. VP will undertake all data analyses. This protocol paper was written by MV and NW with input from all co-authors. NW is guarantor for this paper. All authors read and approved the final manuscript.
Funding This trial is funded by a three year project grant from the Health Research Council of New Zealand (15/202). Approximately NZ$600 000 (€350 000 or US$400 000) was available to run the trial. The e-cigarettes for this trial are being purchased directly from a New Zealand e-cigarette retailer - NZVAPOR. NZVAPOR are not involved in the design, conduct or analysis of the trial, but are providing on-line and phone support to participants regarding use of their allocated e-cigarettes. The e-cigarettes to be used in the trial and NZVAPOR (including the Managing Director) have no links with the tobacco industry. The e-juice for the trial is purchased directly from Nicopharm, Australia. The nicotine patches are supplied by the New Zealand Government via their contract with Novartis. Nicopharm and Novartis are not involved in the design, conduct or analysis of the trial and have no known links with the tobacco industry. Independent testing of the nicotine content of the e-juice will be undertaken by the NicoTar group at Roswell Park Cancer Institute, Buffalo, New York, USA.
Competing interests No authors have received financial support for the submitted work from any companies with a financial interest in the products under investigation. CB has received benefits in kind (accommodation expenses) from a manufacturer of smoking cessation medications. NW has provided consultancy to the manufacturers of smoking cessation medications, received honoraria for speaking at a research meeting and received benefits in kind and travel support from a manufacturer of smoking cessation medications (but over five year ago). NW, CB, MV, GL and VP are currently involved in a clinical trial in which varenicline and matching placebo are supplied by Pfizer under their Investigator-Initiated Research Program. MV has previously undertaken research supported by an unrestricted grant from Pfizer. None of the authors’ spouses, partners or children have financial relationships that may be relevant to the submitted work. All authors have no non-financial interests that may be relevant to the submitted work.
Ethics approval Ethics approval was obtained on the 16/09/2015 from the Northern A Health and Disability Ethics Committee (15/NTA/123).
Provenance and peer review Not commissioned; externally peer reviewed.
Patient consent for publication Not required.