NCT01704196已完成2 期
Phase 2, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Trial of Nepicastat for Cocaine Dependence
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 179
- 试验地点
- 10
- 主要终点
- Abstinence (Weeks 10 - 11)
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of Nepicastat in improving the number of subjects that achieve abstinence from cocaine and reducing cocaine use in subjects with cocaine 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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be at least 18 years of age
- •Is seeking treatment for cocaine dependence
- •Is able to understand and provide written informed consent
- •Has completed all psychological assessments and procedures required during the 7 - 14 day screening period
- •If female, agrees to use an acceptable method of birth control
- •Is, in the opinion of the Investigator, likely to complete the 11-week Treatment Phase of the study
排除标准
- •Please contact the study site for more information
研究组 & 干预措施
Nepicastat
Active Comparator
Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks
干预措施: Nepicastat (Drug)
Placebo
Placebo Comparator
Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Abstinence (Weeks 10 - 11)
时间窗: Weeks 10 - 11
Number of subjects that abstained from cocaine from weeks 10 through 11
次要结局
- Reduction in Use (Weeks 1 - 11)(Baseline through week 11)
研究者
研究点 (10)
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