Gabapentin Treatment of Alcohol Dependence
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Drinking
研究概览
简要总结
Gabapentin treatment for alcohol dependence
详细描述
This is a 12-week, double blind, placebo controlled, dose ranging study to evaluate the efficacy of gabapentin in treating outpatients with alcohol dependence. Subjects receive 900mg or 1800mg gabapentin or placebo daily for 12 weeks accompanied by weekly standardized counseling for alcohol-related behavior, with assessments of alcohol consumption, mood, sleep and alcohol-craving performed each week.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women over age 18 with alcohol dependence
排除标准
- •Currently meets Diagnostic and Statistical Manual 4 Text Revision (DSM-IV-TR) criteria for dependence on illicit substances
- •Significant medical disorders that will increase potential risk or interfere with study participation
- •Women with childbearing potential who are pregnant, nursing, or refuse to use a reliable method of birth control
- •Treatment with an investigational drug in the last month.
研究组 & 干预措施
gabapentin 900mg daily
900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
干预措施: Gabapentin 900mg (Drug)
gabapentin 900mg daily
900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
干预措施: behavioral counseling (Behavioral)
gabapentin 1800mg daily
1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks
干预措施: behavioral counseling (Behavioral)
gabapentin 1800mg daily
1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks
干预措施: gabapentin 1800mg (Drug)
placebo daily
placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
干预措施: behavioral counseling (Behavioral)
placebo daily
placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
干预措施: placebo (Drug)
结局指标
主要结局
Drinking
时间窗: 12-week
Rate of complete abstinence was defined as the number of participants who drank no alcohol during 12 weeks of treatment, where the denominator is the intent to treat population. Rate of heavy drinking abstinence is defined as no heavy drinking days while on study (4 or more for women, 5 or more for men).
次要结局
- Mood(12-week)
- Sleep(12-week)
- Craving(12-week)
研究者
Barbara J. Mason
PI
The Scripps Research Institute