Effect of Varenicline on Fixed-Dose Alcohol Administration in Participants With Alcohol Use Disorders
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Cognitive Function as Measured by Omissions on the CPT
研究概览
简要总结
The purpose of this study is the examine the effect of varenicline on cognition to a high dose (0.08 g/dL) of alcohol (vs. placebo alcohol) over the ascending and descending limb of the blood alcohol curve.
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 and nonsmokers
- •Meet criteria for alcohol use disorders
- •Currently enrolled in NCT00580645
排除标准
- •Any significant current medical or psychiatric conditions that would contraindicate the consumption of alcohol
- •Significant hepatocellular injury
- •Positive test results 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
- •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 protocol
- •Subjects likely to exhibit clinically significant alcohol withdrawal during the study
研究组 & 干预措施
varenicline
varenicline 1mg/day or 2mg/day
干预措施: varenicline (Drug)
placebo
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Cognitive Function as Measured by Omissions on the CPT
时间窗: Following 3 weeks of medication. The CPT task was performed at 60 minutes following alcohol or placebo beverage consumption.
Cognitive function was measured using the Continuous Performance Task (CPT). The CPT assess attention and response inhibition and the main outcome was number of omissions (the number of times the target was present, but the subject did not respond) errors in response to go and stop targets. Participants are presented with "stop" and "go" targets that appear on a computer screen. They are told to press the space bar (respond) to "go" targets and to avoid pressing the space bar when "stop" targets appear. Presented in the data table are the average number of omissions (the number of times the target was present, but the subject did not respond). Higher omission rates indicate a greater level of inattention (range 0-324).
次要结局
未报告次要终点
研究者
Sherry McKee
Associate Professor of Psychiatry
Yale University