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临床试验/NCT00571922
NCT00571922已完成1 期

A Placebo-controlled, Double Blind, Randomized Trial of Acamprosate for the Treatment of Methamphetamine Dependence

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2007年7月最近更新:
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

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

申办方类型
Other
责任方
Sponsor

研究点 (1)

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