Duloxetine Versus Pregabalin for 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
- Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Week at Week 12
研究概览
简要总结
A 12-week, double-blind, placebo-controlled parallel group study will be conducted with 150 outpatients with alcohol dependence, with random assignment to pregabalin 300 mg/d, duloxetine 40 mg/d, or placebo in conjunction with manual-guided behavioral counseling and follow-up visits 1 week and 3 months post-treatment.
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
- Double (Participant, Investigator)
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
- •Males or females 18 years of age
- •Meets DSM-IV criteria for current alcohol dependence and drinking an average of ≥21 drinks weekly for males, ≥14 females,
- •Seeking research-based outpatient treatment for alcohol problems
- •Willing to attend 12 weekly study visits and 2 follow-up visits
- •Have normal bilirubin, and ALT, AST, and GGT values no more than 3x the ULN, and no evidence of hepatic insufficiency
排除标准
- •Active suicidal ideation
- •Medical disorders that will increase potential risk or interfere with study participation
- •Sexually active female subjects with childbearing potential who are pregnant, nursing or refuse to use a reliable method of birth control
- •Males who refuse to use a reliable method of birth control
- •Meets DSM-IV criteria for any other current major AXIS I disorder other than alcohol or nicotine dependence.
- •Inability to understand and/or comply with the provisions of the protocol and consent form
- •Treatment with an antidepressant medication during the two weeks, or fluoxetine during the month, prior to randomization
- •Ongoing treatment with disulfiram (Antabuse), naltrexone (ReVia), acamprosate (Campral) or other medications that may affect study outcomes, e.g., anticonvulsants or other drugs that act on serotonin in the brain
- •Ongoing treatment with drugs that may increase potential risk (Actos),
研究组 & 干预措施
Duloxetine
干预措施: Duloxetine (Drug)
Duloxetine
干预措施: Standardized behavioral therapy (Behavioral)
Pregabalin
干预措施: Pregabalin (Drug)
Pregabalin
干预措施: Standardized behavioral therapy (Behavioral)
Placebo
干预措施: Placebo (Drug)
Placebo
干预措施: Standardized behavioral therapy (Behavioral)
结局指标
主要结局
Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Week at Week 12
时间窗: Baseline and Week 12
Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol.
Change From Baseline in Drinking Quantity and Frequency Using Drinking Days Per Week at Week 12
时间窗: Baseline and Week 12
Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. A drinking day is a day where any alcohol is consumed. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol.
Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Drinking Day at Week 12
时间窗: Baseline and Week 12
Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. A drinking day is a day where any alcohol is consumed. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol.
次要结局
未报告次要终点
研究者
Barbara J. Mason
PI
The Scripps Research Institute