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

Abstract

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/designDesign: 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.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).

Effects of Electronic Nicotine Delivery System on Larynx: Experimental Study

“…Vapor is generated electronically. 3 Although ENDS vapor contains 9-to 450-fold lower levels of toxic and carcinogenic compounds (carbonyls, volatile organic compounds, nitrosamines, and heavy metals) than do tobacco cigarettes, 4 the particles therein are comparable with those of nicotine-containing cigarettes. 5 In addition, one report found metal and silica nanoparticles 6 that may damage mucosal surfaces.…”

The Chemical Components of Electronic Cigarette Cartridges and Refill Fluids: Review of Analytical Methods

“…11 First tests 14 on chemical composition of EC cartridge liquids and aerosol were performed in 2008 by Health New Zealand Ltd to asses safety of Ruyan EC cartridges, the first patented and launched cartridges. 1 One year later, the Food and Drug Administration (FDA) was asked to quantitate the amount of nicotine and impurities in two brands of EC cartridges. The study highlighted the presence of low amounts of nicotine in some bottles of liquid labeled "no nicotine."…”

Forensic analysis of online marketing for electronic nicotine delivery systems

“…Unambiguous claims concerning smoking cessation and health benefits related to ENDS were present in both ENDS advertisements and affiliate websites but not their linked seller websites, despite FDA limits on cessation claims and the limited empirical evidence for efficacy 15–17. To date, no large-scale clinical trials of ENDS effectiveness for smoking cessation or toxicant exposure reduction have been published, although results from one such study for smoking cessation appear to be forthcoming 18. Correspondingly, information on the FDA website states the following: ‘As the safety and efficacy of e-cigarettes have not been fully studied, consumers of e-cigarette products currently have no way of knowing … if there are any benefits associated with using these products.’19 Manufacturers of some dietary supplements have used ‘third party’ sources (eg, fake news websites) to distance themselves from unsubstantiated claims about their products,10 12 and a similar strategy may be in use here to make misleading health claims about ENDS.…”