NCT02205879已完成4 期
Double Blind Placebo Controlled Randomized Clinical Trial of Pregabalin for Alcohol Dependence
St. Petersburg Bekhterev Research Psychoneurological Institute1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Retention in treatment
研究概览
简要总结
The study hypothesis is: Pregabalin is superior to placebo in preventing relapse to drinking and reducing drinking severity
详细描述
This is a two cell double blind placebo controlled randomized clinical trial of pregabalin for alcohol dependence
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
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Alcohol Dependence by ICD-X criteria
排除标准
- •Severe co-morbid psychiatric and somatic diseases
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
pregabalin
Experimental
干预措施: Pregabalin (Drug)
结局指标
主要结局
Retention in treatment
时间窗: three months
Number of subjects retianed in treatment (not relapsed)
次要结局
- Weekly alcohol consumption(three months)
研究者
研究点 (1)
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