Study protocol for a randomised controlled trial of electronic cigarettes versus nicotine patch for smoking cessation.
Study protocol for a randomised controlled trial of electronic cigarettes versus nicotine patch for smoking cessation.
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电子卷烟与尼古丁贴片的随机对照试验的研究方案，用于戒烟。
DOI：
10.1186/1471-2458-13-210
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发表时间：
2013-03-08
影响因子：
4.5
通讯作者：
Walker N
中科院分区：
文献类型：
--
作者：
Bullen C;Williman J;Howe C;Laugesen M;McRobbie H;Parag V;Walker N
电子香烟（电子香烟或电子尼古丁输送系统[ENDS]）是一种外观与香烟大致相似的电动装置，在吸嘴上抽吸时将丙二醇和/或甘油雾输送到使用者的气道。尼古丁和其他物质（例如调味剂）可包含在由装置蒸发的流体中。人们报告使用电子烟来帮助戒烟，研究它们对烟草戒断和渴望的影响表明，电子烟作为戒烟辅助手段具有良好的潜力。然而，迄今为止，还没有足够的把握度随机试验研究其戒烟疗效或安全性。本文概述了这项研究的协议。设计：平行组、3组、随机对照试验。受试者：居住在新西兰（NZ）奥克兰、年龄≥18岁、想要戒烟的人群。干预措施：分层区组随机化，将参与者分配到带有尼古丁盒（16 mg）或安慰剂盒（即无尼古丁）的Elusion™电子烟，或单独使用尼古丁贴片（21 mg）。随机分配到电子烟组的参与者将被告知在戒烟日之前一周和之后12周随意使用它们，而随机分配到贴片的参与者将被告知在同一时期每天使用它们。所有参与者都将获得行为支持，以退出新西兰戒烟热线。主要结局：戒烟日后6个月，经生化证实（呼出一氧化碳）持续戒烟。样本量：657人（尼古丁电子烟和尼古丁贴片组292人，安慰剂电子烟组73人）将在p = 0.05时提供80%的把握度，以检测尼古丁电子烟和尼古丁贴片组之间10%的绝对戒烟差异，以及尼古丁和安慰剂电子烟组之间15%的绝对戒烟差异。这项试验将为关于电子烟监管和可用性的国际辩论和政策提供信息。如果证明是有效和安全的，这些设备可以帮助许多吸烟者作为替代戒烟援助标准尼古丁产品。澳大利亚新西兰临床试验注册中心（ACTRN 12610000866000）。
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. 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. 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. Australian NZ Clinical Trials Registry (ACTRN12610000866000).
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影响因子：
5.2
作者：
Bullen, C.;McRobbie, H.;Laugesen, M.
通讯作者：
Laugesen, M.
影响因子：
5.2
作者：
Trtchounian, Anna;Talbot, Prue
通讯作者：
Talbot, Prue
影响因子：
24.3
作者：
Caponnetto, P.;Cibella, F.;Polosa, R.
通讯作者：
Polosa, R.
影响因子：
5.2
作者：
Etter JF;Bullen C;Flouris AD;Laugesen M;Eissenberg T
通讯作者：
Eissenberg T
影响因子：
5.2
作者：
Rodgers, A;Corbett, T;Jones, M
通讯作者：
Jones, M