• Chris Bullen, Jonathan Williman, Colin Howe, Murray Laugesen, Hayden McRobbie, Varsha Parag, and Natalie Walker.
• National Institute for Health Innovation, School of Population Health, The University of Auckland, Private Bag 92019, Auckland 1142, New Zealand. c.bullen@nihi.auckland.ac.nz
• Bmc Public Health. 2013 Jan 1;13:210.

BackgroundElectronic 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/DesignDesignParallel group, 3-arm, randomised controlled trial.ParticipantsPeople aged ≥18 years resident in Auckland, New Zealand (NZ) who want to quit smoking.InterventionStratified 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 OutcomeBiochemically verified (exhaled carbon monoxide) continuous abstinence at six months after quit day.Sample Size657 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.DiscussionThis 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 RegistrationAustralian NZ Clinical Trials Registry (ACTRN12610000866000).

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