A Randomized Placebo-Controlled Clinical Trial of 5 Smoking Cessation Pharmacotherapies
A Randomized Placebo-Controlled Clinical Trial of 5 Smoking Cessation Pharmacotherapies
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DOI：
10.1001/archgenpsychiatry.2009.142
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发表时间：
2009-11-01
影响因子：
--
通讯作者：
Baker, Timothy B.
中科院分区：
文献类型：
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作者：
Piper, Megan E.;Smith, Stevens S.;Baker, Timothy B.
背景：很少有直接证据表明不同戒烟药物疗法的相对疗效，但需要这些证据来做出有关其临床使用的明智决定。目的：通过安慰剂对照，头对头比较，评估5种戒烟药物治疗干预措施的相对疗效。设计：随机、双盲、安慰剂对照临床试验。设置：两个城市研究站点。病人：在过去的6个月里每天至少抽10支烟的一千五百名成年人报告说他们有戒烟的动机。如果参与者报告使用香烟以外的任何形式的烟草，则被排除在外；目前使用安非他酮；目前患有精神病或精神分裂症的；或者有任何研究药物的医学禁忌。干预措施：参与者被随机分配到6种治疗条件中的1种：尼古丁含片、尼古丁贴片、安非他酮缓释片、尼古丁贴片加尼古丁含片、安非他酮加尼古丁含片或安慰剂。此外，所有参与者都接受了6次个人咨询。主要结局指标：在戒烟后1周（戒烟后）、治疗结束（戒烟后8周）和戒烟后6个月进行生化证实的7天点流行性戒断评估。其他结果包括最初的戒烟、消失的天数、复发的天数和第一次消失后的复发潜伏期。结果：在没有多重比较保护的情况下，所有药物治疗均不同于安慰剂（优势比，1.63-2.34）。有这样的保护作用，只有尼古丁贴片加尼古丁含片(优势比，2.34，P
Context: Little direct evidence exists on the relative efficacies of different smoking cessation pharmacotherapies, yet such evidence is needed to make informed decisions about their clinical use.Objective: To assess the relative efficacies of 5 smoking cessation pharmacotherapy interventions using placebo-controlled, head-to-head comparisons.Design: A randomized, double-blind, placebo-controlled clinical trial.Setting: Two urban research sites.Patients: One thousand five hundred four adults who smoked at least 10 cigarettes per day during the past 6 months and reported being motivated to quit smoking. Participants were excluded if they reported using any form of tobacco other than cigarettes; current use of bupropion; having a current psychosis or schizophrenia diagnosis; or having medical contraindications for any of the study medications.Interventions: Participants were randomized to 1 of 6 treatment conditions: nicotine lozenge, nicotine patch, sustained-release bupropion, nicotine patch plus nicotine lozenge, bupropion plus nicotine lozenge, or placebo. In addition, all participants received 6 individual counseling sessions.Main Outcome Measures: Biochemically confirmed 7-day point-prevalence abstinence assessed at 1 week after the quit date (postquit), end of treatment (8 weeks postquit), and 6 months postquit. Other outcomes were initial cessation, number of days to lapse, number of days to relapse, and latency to relapse after the first lapse.Results: All pharmacotherapies differed from placebo when examined without protection for multiple comparisons (odds ratios, 1.63-2.34). With such protection, only the nicotine patch plus nicotine lozenge (odds ratio, 2.34, P