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在一项安非他酮与安慰剂对照的临床试验中,对治疗分配的感知与戒烟。

Perceived treatment assignment and smoking cessation in a clinical trial of bupropion versus placebo.

机构信息

Department of Medicine and Center for Health Equity, University of Minnesota Minneapolis, MN 55414, USA.

出版信息

Nicotine Tob Res. 2013 Feb;15(2):567-71. doi: 10.1093/ntr/nts143. Epub 2012 Sep 4.

Abstract

INTRODUCTION

Psychoactive effects of smoking cessation medi cations such as bupropion may allow participants in smoking cessation clinical trials to correctly guess their treatment assignment at rates greater than chance. Previous research has found an association between perceived treatment assignment and smoking cessation rates among moderate to heavy smokers (≥ 10 cigarettes per day [cpd]) in two bupropion clinical trials.

METHODS

The aim of this study was to determine the impact of perceived treatment assignment on end-of-treatment cotinine-verified smoking abstinence at Week 7 and Week 26 among African American light smokers (≤ 10 cpd) enrolled in a double-blind, placebo-controlled study of bupropion. Participants (n = 390) included in this study reported their perceived treatment assignment on the end-of-treatment (Week 7) survey.

RESULTS

Participants were predominantly female (63.1%), 48.1 years of age (SD = 11.2), and smoked an average of 8 cpd (SD = 2.5). Participants given bupropion were more likely to correctly guess their treatment assignment (69%; 140/203) than those assigned to placebo (51.3%; 96/187) (p < .0001). After adjusting for treatment condition, participants who perceived assignment to bupropion versus placebo were not more likely to be abstinent than those who perceived assignment to placebo at Week 7 or at Week 26. The interaction between treatment and perceived treatment assignment was also nonsignificant.

CONCLUSIONS

Consistent with two previous studies testing bupropion, participants assigned to bupropion were more likely to correctly guess their treatment assignment than those assigned to placebo. However, in contrast to previous studies with heavier smokers, perceived treatment assignment did not significantly impact cotinine-verified abstinence in light smokers.

摘要

简介

戒烟药物(如安非他酮)的精神活性作用可能会使戒烟临床试验的参与者以高于随机的概率正确猜测他们的治疗分配。先前的研究发现,在两项安非他酮临床试验中,中度至重度吸烟者(每天≥10 支香烟[CPD])中,感知的治疗分配与戒烟率之间存在关联。

方法

本研究的目的是确定在接受安非他酮双盲、安慰剂对照研究的 390 名非裔美国轻度吸烟者(≤10CPD)中,感知的治疗分配对治疗结束时(第 7 周)和第 26 周时经可替宁验证的吸烟戒断的影响。参与者在治疗结束(第 7 周)调查中报告了他们对治疗分配的感知。

结果

参与者主要为女性(63.1%),年龄为 48.1 岁(标准差[SD]=11.2),平均吸烟 8 支/天(SD=2.5)。接受安非他酮治疗的参与者更有可能正确猜测自己的治疗分配(69%;140/203),而安慰剂组的参与者为 51.3%(96/187)(p<.0001)。调整治疗条件后,与感知接受安慰剂治疗相比,感知接受安非他酮治疗的参与者在第 7 周或第 26 周时的戒烟率并没有更高。治疗和感知治疗分配之间的相互作用也不显著。

结论

与两项测试安非他酮的先前研究一致,与接受安慰剂治疗的参与者相比,接受安非他酮治疗的参与者更有可能正确猜测自己的治疗分配。然而,与以前对重度吸烟者的研究不同,在轻度吸烟者中,感知的治疗分配并没有显著影响可替宁验证的戒烟率。

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