NCT01266655已完成2 期
Baclofen for the Treatment of Alcohol Dependence - BACLAD
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Total abstinence from alcohol and cumulative abstinence duration
研究概览
简要总结
There is first evidence from preclinical and clinical studies for the efficacy of the selective GABA-B receptor agonist baclofen in the treatment of alcohol dependence. The aim of this trial is to evaluate the efficacy and safety of individually titrated high-dose baclofen for relapse prevention in alcohol-dependent patients.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of alcohol dependence according to ICD-10 (International Classification of Mental and Behavioural Disorders, 10th revision) and DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th revision) criteria
- •An alcohol intake of at least two heavy drinking days per week on average (men ≥ 5 drinks per day; women ≥ 4 drinks per day) and an average overall consumption of 21 drinks per week or more for men and 14 drinks per week or more for women during the 4 weeks before detoxification (one standard drink is equal to 12 g absolute alcohol)
- •Last alcohol consumption within 7-21 days before randomisation
- •Sufficient German language capabilities
排除标准
- •Pregnancy and/or currently breastfeeding
- •Clinical significant medical conditions or observed abnormalities
- •Psychiatric illness undergoing treatment with psychoactive drugs
- •Epilepsy or epileptiform convulsions
- •Addiction to drugs other than nicotine
研究组 & 干预措施
Baclofen
Experimental
干预措施: Baclofen (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Total abstinence from alcohol and cumulative abstinence duration
时间窗: 13-16 weeks (depending on the individually tolerated baclofen dose)
次要结局
- Number of adverse events(24 weeks)
研究者
研究点 (1)
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