NCT00345371已完成2 期
Phase 2, Double-Blind, Placebo-Controlled Trial of Topiramate for the Treatment of Methamphetamine 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
- 140
- 试验地点
- 8
- 主要终点
- Abstinence (Weeks 6 - 12)
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of topiramate as compared to placebo in reducing methamphetamine use in subjects with methamphetamine 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
- 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
- •Treatment seeking individuals as the time of the study
- •Must be able to proved written informed consent
- •Must have a body mass index greater than 18 kg/m(2)
- •Must meet DSM-IV criteria for methamphetamine dependence
- •Must currently be using methamphetamine as confirmed by a positive urine test over the past 14 days
- •If female of child bearing potential, must agree to use birth control
排除标准
- •Please contact the site for more information
研究组 & 干预措施
Topiramate
Active Comparator
Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks.
干预措施: Topiramate (Drug)
Placebo Oral Tablet
Placebo Comparator
After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks.
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Abstinence (Weeks 6 - 12)
时间窗: weeks 6 through 12
The number of participants who abstained from methamphetamine from weeks 6 through 12
次要结局
- Abstinence (Weeks 1 - 12)(Weeks 1 through 12)
研究者
研究点 (8)
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