NCT01813656终止4 期
A Multiple-Center, Randomized, Double-Blind Study of Aripiprazole for Treatment of Methamphetamine Dependence
Wei Hao1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2012年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- abstinent time of Methamphetamine addict
研究概览
简要总结
Methamphetamine substance use is common worldwide. No approved pharmacologic treatments for methamphetamine dependence exist. Aripiprazole are Second generation antipsychotics，but have different pharmacological effects of neurotransmitters.To determine whether mirtazapine would reduce methamphetamine use among mehtamphetamine addicts.
详细描述
Methods:A Multiple-Center, Randomized, Double-Blind.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients,Diagnostic and Statistical Manual of Mental Disorders 4thed. (DSM-IV) criteria for Methamphetamine dependence.
- •Must sign a Information consent form.
- •Required to provide detailed address and phone number
排除标准
- •Serious organic disease.
- •Suicide ideation or hurt others.
- •Taking antipsychotic within two weeks before.
- •drug allergy to Risperidone or Aripiprazole.
- •pregnancy and breastfeeding women.
研究组 & 干预措施
Aripiprazole
Experimental
Aripiprazole arm,5mg/pill,10mg/day.last12weeks.
干预措施: Aripiprazole (Drug)
Sugar pill
Placebo Comparator
placebo arm,5mg/pill,10mg/day,last12weeks
干预措施: placebo (Drug)
结局指标
主要结局
abstinent time of Methamphetamine addict
时间窗: up to 3 months
methamphetamine-positive urine test results,self-reports of substance use
次要结局
- number of Participants with Adverse Events as a Measure of Safety and Tolerability(up to 3 months)
研究者
Wei Hao
The Second Xiangya Hospital of Cental South University
Central South University
研究点 (1)
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