Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2019 Feb 25;9(2):e023659.
doi: 10.1136/bmjopen-2018-023659.

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

Natalie Walker  1 , Marjolein Verbiest  1   2 , Tomasz Kurdziel  1 , George Laking  3 , Murray Laugesen  4 , Varsha Parag  1 , Chris Bullen  1
Affiliations

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

Natalie Walker et al. BMJ Open. .

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.

Keywords: cessation; e-cigarettes; effectiveness; electronic cigarettes; nicotine patch; randomised controlled trial; safety.

PubMed Disclaimer

Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Estimated effect sizes for planned comparisons.
Figure 2
Figure 2
Design of the trial along the ‘pragmatic to explanatory’ continuum.
See this image and copyright information in PMC

References

    1. Ferguson SG, Shiffman S. The relevance and treatment of cue-induced cravings in tobacco dependence. J Subst Abuse Treat 2009;36:235–43. 10.1016/j.jsat.2008.06.005 - DOI - PubMed
    1. Przulj D, McRobbie H. The effect of sensorimotor replacement on smoking cessation and craving. Open Addict J 2012;5:41–50. 10.2174/1874941001205010041 - DOI
    1. Dawkins L, Turner J, Roberts A, et al. ‘Vaping’ profiles and preferences: an online survey of electronic cigarette users. Addiction 2013;108:1115–25. 10.1111/add.12150 - DOI - PubMed
    1. Bullen C, McRobbie H, Thornley S, et al. Effect of an electronic nicotine delivery device (e cigarette) on desire to smoke and withdrawal, user preferences and nicotine delivery: randomised cross-over trial. Tob Control 2010;19:98–103. 10.1136/tc.2009.031567 - DOI - PubMed
    1. Glasser AM, Collins L, Pearson JL, et al. Overview of electronic nicotine delivery systems: a systematic review. Am J Prev Med 2017;52:e33–e66. 10.1016/j.amepre.2016.10.036 - DOI - PMC - PubMed

Publication types

MeSH terms

Associated data