A Pilot Trial of Dextroamphetamine for Methamphetamine Dependence
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Subjects treated with dextroamphetamine will have better outcomes than subjects treated with placebo, as indicated by the number of urine samples that do not indicate new use of MA (the primary outcome measure)
研究概览
简要总结
The purpose of this study is to assess the safety and effectiveness dextroamphetamine to help methamphetamine users quit or cut down on their use. The study lasts for 9 weeks. Eligible participants will attend research visits twice per week, and will receive individual counseling sessions once per week for all 9 weeks. 50% of the participants will receive the active medication while the other 50% will receive the placebo (sugar pill). Neither the participant or the study team will know if the participant is receiving the placebo or active drug.
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, 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
- •18-50 yrs. old
排除标准
- •pregnant or lactating females
- •Contact site for additional information
研究组 & 干预措施
Dextroamphetamine
Active drug
干预措施: Dextroamphetamine (Drug)
Placebo
Placebo of drug
干预措施: Placebo (Drug)
结局指标
主要结局
Subjects treated with dextroamphetamine will have better outcomes than subjects treated with placebo, as indicated by the number of urine samples that do not indicate new use of MA (the primary outcome measure)
时间窗: Twice per week for 8 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