A Randomized, Placebo-Controlled Trial of Modafinil for Methamphetamine Dependence
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Urine Samples Negative for Methamphetamine
研究概览
简要总结
The proposed study will establish the safety and efficacy of modafinil in the treatment of methamphetamine dependence, as well as assess the affects of modafinil on cognitive function in methamphetamine users and on methamphetamine withdrawal symptoms. In this outpatient trial, methamphetamine- dependent, treatment-seeking subjects will receive modafinil or placebo daily for four weeks, along with weekly Motivational Enhancement Therapy sessions. This study will be conducted at the Addiction & Pharmacology Laboratory in San Francisco, CA, and at the New Leaf Treatment Center in Lafayette, CA, and is expected to last one year.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 50 years
- •Patient is agreeable to conditions of study and signs consent form
排除标准
- 未提供
研究组 & 干预措施
Modafinil
干预措施: Modafinil (Drug)
结局指标
主要结局
Urine Samples Negative for Methamphetamine
时间窗: Twice weekly for 4 weeks
次要结局
未报告次要终点
研究者
Gantt Galloway, PharmD
Scientist
California Pacific Medical Center Research Institute