New Approaches to Cocaine Abuse Medications (A)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Cocaine Use
研究概览
简要总结
The purpose of this study is to measure the effect of desipramine in cocaine abusers selected for major depression or dysthymia.
详细描述
This is a randomized, 12-week, double-blind, 'placebo-controlled trial of outpatients meeting DSM-III-R criteria for cocaine dependence and major depression or dysthymia (by SCID interview). Participants were treated with desipramine, up to 300 mg per day, or matching placebo. All patients received weekly individual manual-guided relapse prevention therapy. Weekly outcome measures included the Clinical Global Impression Scale, self-reported cocaine use and craving, urine toxicology, and the Hamilton Depression Scale.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Desipramine
Participants were treated with desipramine, up to 300 mg per day. All patients received weekly individual manual-guided relapse prevention therapy.
干预措施: Desipramine (Drug)
Placebo
Participants were treated with matching placebo. All patients received weekly individual manual-guided relapse prevention therapy.
干预措施: Placebo (Drug)
结局指标
主要结局
Cocaine Use
时间窗: Weekly over a 12 week period.
Clinical Global Impression Scale, self-reported cocaine use and craving, urine toxicology.
Depression
时间窗: Bi-weekly over a 12 week period.
Hamilton Depression Scale
次要结局
未报告次要终点