Fyn Kinase Inhibitors and Alcohol Drinking
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in the Number of Drinks Consumed From Baseline to Day 8 (Minus Baseline)
研究概览
简要总结
The purpose of this study is to evaluate the effects of the study medication, saracatinib/AZD0530 (placebo or 125 mg/day) on alcohol drinking behavior in a laboratory setting in which participants are given an initial drink of alcohol followed by the choice to drink up to 12 more drinks over a three-hour period. The investigators hypothesize that saracatinib will reduce craving and number of drinks consumed prior to and after exposure to the initial drink of alcohol and during the three hour drinking period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 21-50
- •Able to read English at 6th grade level or higher and to complete study evaluations
- •Regular alcohol drinker
排除标准
- •Individuals who are seeking alcohol treatment
- •Medical conditions that would contraindicate the use of saracatinib
- •Regular use of other substances
研究组 & 干预措施
125 mg saracatinib
Participants will take 125 mg of saracatinib daily for 8 days.
干预措施: Saracatinib (Drug)
Placebo
Participants will take placebo daily for 8 days.
干预措施: Placebos (Drug)
结局指标
主要结局
Change in the Number of Drinks Consumed From Baseline to Day 8 (Minus Baseline)
时间窗: Baseline and Day 8
Change in the number of standard drinks consumed at the drinking session (ADP 2) after taking study medication minus the number of standard drinks consumed at baseline (ADP 1).
Craving-Baseline Adjusted Total Area Under the Curve (AUC) During the Drinking Session Using the YCS
时间窗: Baseline and Day 7
Craving for alcohol based on Yale Craving Scale (YCS), scores ranging from 0-112 mm on a visual analog scale, with higher measurements indicating higher craving. The baseline-adjusted craving is change score from baseline at Day 7.
次要结局
- Area Under the Curve (AUC) During the Drinking Session Using the Sedation Responses to Alcohol (BAES)(Day 8 Adlib)
- Area Under the Curve (AUC) During the Drinking Session Using the Stimulation Responses to Alcohol (BAES)(Day 8 Adlib)
研究者
Suchitra Krishnan-Sarin
Professor of Psychiatry
Yale University