Do Treatments for Smoking Cessation Affect Alcohol Drinking?
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of Drinks Consumed
研究概览
简要总结
The purpose of this study is to examine the effect of smoking cessation medications on alcohol drinking. Effect of 2mg/day, 1mg/day, placebo varenicline was evaluated.
Following 7 days of medication pre-treatment to achieve steady state levels, participants complete a laboratory session assessing alcohol self-administration behavior.
Study enrolls heavy drinking smokers (not tested under nicotine deprivation), non-daily smokers, and nonsmokers. Volunteers are administered either varenicline (Chantix) or placebo.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •21 years old or older
- •Able to read and write in English
- •Smokers, non-daily smokers, and non-smokers
- •Heavy Drinkers and/or meet criteria for alcohol use disorders
排除标准
- •Any significant current medical or psychiatric conditions that would contraindicate the consumption of alcohol
- •Significant hepatocellular injury
- •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 severe mental illness
- •Prescription of any psychotropic drug in the 30 days prior to study enrollment
- •Blood donation within the past 8 weeks
- •Individuals who are seeking treatment for drinking or smoking or who have attempted to quit drinking or smoking within the past 3 months
- •Specific exclusions for administration of bupropion not specified above including: having taken monoamine inhibitors in the past six 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
- •Subjects likely to exhibit clinically significant alcohol withdrawal during the study
研究组 & 干预措施
Placebo
Placebo Controlled
干预措施: placebo (Drug)
varenicline
varenicline 1mg/day or 2mg/day
干预措施: varenicline (Drug)
结局指标
主要结局
Number of Drinks Consumed
时间窗: 2 hour ad-lib drinking period, during the laboratory session (Day 8)
number of drinks consumed during hour 1 and hour 2 of the 120 minute alcohol self-administration session
次要结局
- Alcohol Craving(during laboratory session (Day 8) at baseline)
研究者
Sherry McKee
Associate Professor of Psychiatry
Yale University