A Double-Blind Study of N-Acetyl Cysteine Plus Naltrexone in the Treatment of Methamphetamine Dependence
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Penn Craving Scale
研究概览
简要总结
The goal of the proposed study is to evaluate the efficacy and safety of N-Acetyl Cysteine (NAC) in combination with naltrexone in methamphetamine dependence.
详细描述
Forty subjects with DSM-IV methamphetamine dependence will receive 8 weeks of double-blind combination medication (NAC plus naltrexone) or placebo. The hypothesis to be tested is that NAC plus naltrexone will be effective and well tolerated in patients with methamphetamine dependence compared to placebo. The proposed study will provide needed data on the treatment of a public health crisis that currently lacks a clearly effective treatment.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men and women age 18-65
- •current DSM-IV methamphetamine dependence.
排除标准
- •unstable medical illness
- •history of seizures
- •myocardial infarction within 6 months
- •current pregnancy or lactation, or inadequate contraception in women of childbearing potential
- •any thoughts of suicide
- •lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder
- •previous treatment with N-Acetyl Cysteine or naltrexone
- •treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline
- •abnormal liver function tests at screening
- •diagnosis of asthma
- •current use of opiates.
研究组 & 干预措施
Naltrexone plus N-Acetyl Cysteine
Naltrexone tablets
N-Acetyl Cysteine: 600mg tablets, daily
干预措施: Naltrexone plus N-Acetyl Cysteine (Drug)
Placebo
Inactive placebo ("sugar pill")
干预措施: Placebo (Drug)
结局指标
主要结局
Penn Craving Scale
时间窗: beginning and at each visit until the end of their participation in the study
used to measure cravings to use drugs over the past week. Range of TOTAL scores is 0-30. A lower score indicates a better outcome, while a higher score indicates a worse outcome.
次要结局
未报告次要终点