NCT00580853已完成2 期
The Effect of Varenicline (Chantix) and Bupropion (Zyban) on Smoking Lapse Behavior
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Latency to Initiate Ad-lib Smoking Session
研究概览
简要总结
The purpose of this study is to examine how smoking cessation medications (varenicline, bupropion) affect the ability to resist smoking and also subsequent ad-lib smoking in non-treatment seeking daily smokers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ages 18-55
- •able to read and write in English
排除标准
- •any significant current medical or psychiatric conditions that would contraindicate smoking
- •current Diagnostic and Statistical Manual IV abuse or dependence of other substances, other than nicotine dependence or alcohol abuse
- •positive test result at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines
- •women who are pregnant or nursing
- •suicidal, homicidal, or evidence of current severe mental illness
- •participants prescribed any psychotropic drug in the 30 days prior to study enrollment
- •blood donation within the past 6 weeks
- •individuals seeking treatment for smoking cessation or have attempted to quit smoking within the past 3 months
- •specific exclusions for bupropion administration not already specified, including: have taken monoamine inhibitors in the past 6 weeks; history of anorexia or bulimia; previous hypersensitivity to bupropion; history of alcohol or drug dependence in the past year; history of seizure disorder of any etiology
- •known allergy to varenicline or taking H2blockers
- •participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current study
研究组 & 干预措施
varenicline
Experimental
varenicline 2mg/day
干预措施: varenicline (Drug)
Bupropion
Experimental
Bupropion 300mg/day
干预措施: bupropion (Drug)
Placebo
Placebo Comparator
Placebo Control
干预措施: Placebo (Drug)
结局指标
主要结局
Latency to Initiate Ad-lib Smoking Session
时间窗: 0 to 50 minutes
minutes to start smoking (range 0 to 50 minutes)
次要结局
- Number of Cigarettes Smoked During the 60 Minute Ad-lib Period(60 minutes)
研究者
研究点 (1)
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