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临床试验/NCT00086255
NCT00086255已完成2 期

Tiagabine for the Treatment of Cocaine Dependence

National Institute on Drug Abuse (NIDA)8 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2002年10月最近更新:
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

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

申办方类型
Nih

研究点 (8)

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