Study protocol for a randomised controlled trial of electronic cigarettes versus nicotine patch for smoking cessation

BMC Public Health

Natalie Walker³  Varsha Parag³  Hayden McRobbie¹  Murray Laugesen⁴  Colin Howe³  Jonathan Williman²  Chris Bullen³ 

[1] Queen Mary University of London, Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry, Charterhouse Square, London, UK;Department of Public Health and General Practice, University of Otago, Christchurch, New Zealand;National Institute for Health Innovation, School of Population Health, The University of Auckland, Private Bag 92019, Auckland 1142, New Zealand;Health New Zealand Ltd, Lyttelton, Christchurch, New Zealand

关键词: Nicotine;    Randomised controlled trial;    Safety;    Efficacy;    Cessation;    ENDS;    E-cigarettes;    Electronic cigarettes;   

Others  :  1162469
DOI  :  10.1186/1471-2458-13-210

 received in 2013-01-18, accepted in 2013-02-25,  发布年份 2013

【 摘 要 】

Background

Electronic cigarettes (e-cigarettes or electronic nicotine delivery systems [ENDS]) are electrically powered devices generally similar in appearance to a cigarette that deliver a propylene glycol and/or glycerol mist to the airway of users when drawing on the mouthpiece. Nicotine and other substances such as flavourings may be included in the fluid vaporised by the device. People report using e-cigarettes to help quit smoking and studies of their effects on tobacco withdrawal and craving suggest good potential as smoking cessation aids. However, to date there have been no adequately powered randomised trials investigating their cessation efficacy or safety. This paper outlines the protocol for this study.

Methods/design

Design: Parallel group, 3-arm, randomised controlled trial. Participants: People aged ≥18 years resident in Auckland, New Zealand (NZ) who want to quit smoking. Intervention: Stratified blocked randomisation to allocate participants to either Elusion™ e-cigarettes with nicotine cartridges (16 mg) or with placebo cartridges (i.e. no nicotine), or to nicotine patch (21 mg) alone. Participants randomised to the e-cigarette groups will be told to use them ad libitum for one week before and 12 weeks after quit day, while participants randomised to patches will be told to use them daily for the same period. All participants will be offered behavioural support to quit from the NZ Quitline. Primary outcome: Biochemically verified (exhaled carbon monoxide) continuous abstinence at six months after quit day. Sample size: 657 people (292 in both the nicotine e-cigarette and nicotine patch groups and 73 in the placebo e-cigarettes group) will provide 80% power at p = 0.05 to detect an absolute difference of 10% in abstinence between the nicotine e-cigarette and nicotine patch groups, and 15% between the nicotine and placebo e-cigarette groups.

Discussion

This trial will inform international debate and policy on the regulation and availability of e-cigarettes. If shown to be efficacious and safe, these devices could help many smokers as an alternative smoking cessation aid to standard nicotine products.

Trial registration

Australian NZ Clinical Trials Registry (ACTRN12610000866000).

【 授权许可】

   
2013 Bullen et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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