NCT00571922已完成1 期
A Placebo-controlled, Double Blind, Randomized Trial of Acamprosate for the Treatment of Methamphetamine Dependence
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Methamphetamine Abstinence
研究概览
简要总结
This clinical trial will compare 10 week treatment with acamprosate (2 gr/day) versus placebo, combined with weekly abstinence oriented individual counseling, in methamphetamine dependent patients, 72 subjects will be enrolled, with an interim analysis scheduled after 36 enrolled. Primary outcome is methamphetamine absitience over the 10 week treatment period, and the last 2 weeks of treatment. Abstinence is defined on a weekly basis as no urine positive of methamphetamine (or amphetamine) and self-report of not use for the 7 day period. Secondary measures include treatment retention, drug craving, mood, and safety.
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
- •Methamphetamine dependence
- •Treatment seeking
- •Urine sample (+) for methamphetamine
排除标准
- •Pregnancy
- •Dependence on other drugs (except nicotine)
- •DSM-IV axis I disorder unrelated to drug abuse
- •Serious medical condition in clinicians opinion.
- •Untreated syphilis
- •Allergy to acamprosate
- •Methadone, or other ORP, maintenance
研究组 & 干预措施
Acamprosate
Active Comparator
干预措施: Acamprosate (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Methamphetamine Abstinence
时间窗: 7 day
次要结局
- Craving(7 day)
研究者
研究点 (1)
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