NCT00086255已完成2 期
Tiagabine for the Treatment of Cocaine Dependence
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 8
- 主要终点
- Drug use
研究概览
简要总结
The purpose of this study is to assess tiagabine for the treatment of cocaine dependence.
详细描述
To assess the efficacy and safety of tiagabine in reducing cocaine use in subjects with cocaine dependence. It is hypothesized that tiagabine treatment, compared to placebo, will be associated with fewer days of cocaine use as assessed by self-report confirmed with urine assays for benzoylecgonine (BE). This is a double-blind, placebo-controlled, parallel-group design study, in which, after screening and a 2-week baseline assessment period, subjects will be equally randomly assigned to 1 of 2 treatment groups, tiagabine or matched placebo.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be at least 18 years of age and be seeking treatment for cocaine dependence. Have the ability to understand, and having understood, provide written informed consent. If female, agree to use a method of birth control as indicated by the clinician. Please contact the participating site in your area for more information.
排除标准
- •Please contact the participating site in your area for more information.
结局指标
主要结局
Drug use
Cocaine use
Addiction severity
Clinical improvement
次要结局
未报告次要终点
研究者
研究点 (8)
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