Gabapentin for Relapse Prevention: Alcohol Withdrawal Effects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Percent of Subjects With no Heavy Drinking Days (PSNHDD)
研究概览
简要总结
This treatment study is a 16-weeks outpatient clinical trial where subjects with alcohol dependence will get medication, which might help them to reduce or stop their drinking, or a placebo ( placebo is a capsule that looks the same as the investigational drug, but has no real medication. It is a "sugar pill").
详细描述
This treatment study is a 16-weeks outpatient clinical trial where subjects will get medication, which might help them to reduce or stop their drinking or a placebo ( placebo is a capsule that looks the same as the investigational drug, but has no real medication. It is a "sugar pill"). This study will recruit and randomize subjects who have expressed an interest in receiving treatment for alcohol dependence. Upon enrollment into this study there will be 11 outpatient visits. Each visit will last about 1-1.5 hours.
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
- 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
- 否
入选标准
- •Meets criteria for alcohol use disorder based on DSM-5 criteria
- •Meets criteria for history of alcohol withdrawal based on DSM-5 criteria
- •Able to maintain abstinence for a minimum of 3 days prior to randomization as verified by self report, urine ETG, and breathalyzer.
排除标准
- •Significant psychiatric or medical illness
- •No other substance abuse
- •Taking other medications known to treat alcohol use disorder
- •Unstable living arrangements
- •Significant legal problems pending
研究组 & 干预措施
Gabapentin
Gabapentin up to 1200 mg per day in 3 divided doses
干预措施: Gabapentin (Drug)
placebo
matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percent of Subjects With no Heavy Drinking Days (PSNHDD)
时间窗: 4 months
The primary dependent variable will be the percent of subjects with no heavy drinking days (4 or more standard drinks for women and 5 or more standard drinks for men). Participants will report their daily alcohol use with using a daily calendar. No heavy drinking days is corrected for %dCDT.
次要结局
- Percent of Subjects With no Drinking Days (PSNDD)(4 months)