Perceived treatment assignment and smoking cessation in a clinical trial of bupropion versus placebo.
Perceived treatment assignment and smoking cessation in a clinical trial of bupropion versus placebo.
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安非他酮与安慰剂临床试验中感知的治疗分配和戒烟。
DOI：
10.1093/ntr/nts143
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发表时间：
2013
期刊：
影响因子：
--
通讯作者：
Ahluwalia,JasjitS
中科院分区：
文献类型：
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作者：
Buchanan,TaneishaS;SandersonCox,Lisa;Thomas,JanetL;Nollen,NicoleL;Berg,CarlaJ;Mayo,MatthewS;Ahluwalia,JasjitS
简介安非他酮等戒烟药物的心理作用可能使戒烟临床试验的参与者以高于偶然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]）的感知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参加一项双盲、安慰剂对照研究的非洲裔美国轻度吸烟者（≤10 cpd）在第7周和第26周时感知治疗分配对治疗结束时可替宁验证的戒烟率的影响安非他酮。本研究中的参与者 (n= 390) 报告了他们在治疗结束（第 7 周）调查时所感知的治疗分配。结果参与者主要为女性 (63.1%)，年龄为 48.1 岁 (SD= 11.2)，平均吸烟量为 8 cpd (SD= 2.5)。接受安非他酮的参与者比接受安慰剂的参与者 (51.3%; 96/187) 更有可能正确猜测他们的治疗分配 (69%; 140/203) (p< .0001)。调整治疗条件后，在第 7 周或第 26 周，感知到分配到安非他酮与安慰剂的参与者并不比感知到分配到安慰剂的参与者更有可能戒烟。治疗和感知到的治疗分配之间的相互作用也不显着。结论与之前测试安非他酮的两项研究一致，分配到安非他酮的参与者比分配到安慰剂的参与者更有可能正确猜测他们的治疗分配。然而，与之前针对重度吸烟者的研究相比，感知到的治疗分配并没有显着影响轻度吸烟者经可替宁验证的戒烟情况。
IntroductionPsychoactive 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.MethodsThe 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.ResultsParticipants 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.ConclusionsConsistent 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.