Bupropion Treatment for Smokers in Recovery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- Smoking Abstinence
研究概览
简要总结
Smoking is often a problem for alcohol dependent individuals. Many people who seek treatment for alcohol dependence are unable to quit smoking. The purpose of this study is to evaluate the effectiveness of bupropion, an antidepressant medication, in treating smokers receiving treatment for alcohol dependence.
详细描述
Past research suggests that over 75% of alcohol dependent individuals in early alcohol recovery smoke cigarettes; smoking-related mortality exceeds alcohol-related mortality in this population. Many alcohol dependent individuals in early recovery are interested in smoking cessation treatment; however, studies indicate that these smokers find it very difficult to quit smoking. More effective treatment methods are needed for smokers in early alcohol recovery. Bupropion is a dopaminergic antidepressant that may be effective in treating nicotine dependent individuals. The purpose of this study is to evaluate the effectiveness of bupropion in nicotine dependent individuals receiving treatment for alcohol dependence. In addition, this study will investigate the psychological mechanisms that may mediate the efficacy of bupropion in smoking cessation. We will also collect DNA from subjects in order to explore whether response to bupropion is mediated by particular genetic variants in the dopaminergic, metabolic and nicotinic receptor systems of smokers.
Participants will be randomly assigned to receive either 300 mg of bupropion or placebo, daily for 8 weeks. In addition, all participants will receive a nicotine patch for 7 weeks. This will consist of a 21-mg nicotine patch for 4 weeks, a 14-mg nicotine patch for 2 weeks, and a 7-mg nicotine patch for 1 week. All participants will undergo seven counseling sessions. Follow-up visits will occur at Weeks 7, 12, and 24. Pre-quit variables (e.g., smoking satisfaction) and three post-quit variables (craving, nicotine withdrawal, and negative effects) will be evaluated at all study visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Smokes a minimum of 10 cigarettes daily for at least 1 year prior to study entry
- •Abstinence from alcohol and other non-nicotine drugs for between 1 and 12 months at time of study entry
- •Meets criteria for alcohol dependence or abuse in the 12 months prior to study entry
排除标准
- •History of seizures, head trauma and/or severe hepatic cirrhosis
- •Current use of medications known to affect smoking behavior and/or cessation
- •Use of tricyclic antidepressant medication and monoamine oxidase inhibitors
- •Major depressive disorder within the month prior to study entry
- •Eating disorder within the year prior to study entry
- •History of bipolar or psychotic disorder
- •Pregnant or breastfeeding
- •Unstable serious medical disorder
- •History of migraines
- •Currently using smokeless tobacco, pipes, or cigars
研究组 & 干预措施
2
participants in this arm receive bupropion
干预措施: Bupropion (Drug)
1
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Smoking Abstinence
时间窗: week 7, week 11 and week 24 after scheduled quit day
The number of subjects in each treatment group who were smoking abstinent (7-day point prevalence) at week 7 (end of treatment), week 11 and week 24.
次要结局
未报告次要终点
研究者
David Kalman
Principal Investigatgor
National Institute on Drug Abuse (NIDA)
