Phase 2, Double-Blind, Placebo Controlled Trial of Cabergoline for the Treatment of Cocaine Dependence
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- To assess the efficacy of cabergoline in reducing cocaine use in subjects with cocaine dependence
研究概览
简要总结
The purpose of this study is to assess cabergoline for the Treatment of Cocaine Dependence
详细描述
To assess the efficacy and safety of cabergoline in reducing cocaine use in subjects with cocaine dependence. This is a DB, placebo-controlled, parallel group design study where subjects will receive either .5mg cabergoline or placebo for 12 weeks with a 4 week follow-up.
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
- Triple (Participant, Care Provider, Investigator)
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 have a DSM-4 criteria for cocaine dependence; be seeking treatment for cocaine dependence; have the ability to understand and provide written informed consent; females of child-bearing potential using proper method of birth control.
排除标准
- •Additional criteria available during screening at the site.
研究组 & 干预措施
Cabergoline
Subjects received one tablet of 0.5 mg of cabergoline tablet per week for 12 weeks.
干预措施: Cabergoline (Drug)
Placebo
Subjects received one tablet of 0.5 mg of cabergoline matched placebo tablet per week for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
To assess the efficacy of cabergoline in reducing cocaine use in subjects with cocaine dependence
时间窗: Week 12
Success in the reduction of cocaine use was determined by comparing cocaine non-use days (self-report confirmed or disproved by urine BE level at each study visit) expressed as the weekly mean proportion of non-use days to the total number of non-missing study days that week.
次要结局
- Reduction in cocaine use(12 weeks)