N-acetylcysteine in Alcohol Dependence
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Alcohol Consumption (Percentage of Heavy Drinking Days)
研究概览
简要总结
The present study is designed to find out if N-acetylcysteine works in reducing alcohol drinking and craving.
详细描述
The 2 groups (placebo and N-acetylcysteine) will be compared in a double-blind, placebo-controlled trial. The total study duration is 9 weeks which includes a 1-week screening period and an 8-week randomized study drug treatment period.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 - 65
- •alcohol dependence by DSM-IV
- •heavy drinking at least 4 times in the past month
- •able to provide informed consent
排除标准
- •current drug abuse or dependence by DSM-IV criteria (except nicotine or cannabis)
- •current psychotic disorders, bipolar disorders, or cognitive disorders
- •current suicidal or homicidal ideation
- •positive illicit drug screen (except cannabis)
- •Clinical Institute Withdrawal Assessment for Alcohol, Revised >15
- •initiation of individual therapy or counseling in the past 3 months
- •changes in doses of psychiatric medications in the past 3 months
- •clinically unstable cardiac, hepatic, renal, neurologic, or pulmonary disease
- •current use of naltrexone, disulfiram or acamprosate
- •pregnant or nursing women, or inadequate birth control methods in women of childbearing potential
研究组 & 干预措施
N-acetylcysteine
Patients will take oral N-acetylcysteine 900 mg/day for 1 week, 1800 mg/day for 1 week, 2700 mg/day for 1 week, and then 3600 mg/day.
干预措施: N-acetylcysteine (Drug)
Placebo
Patients will take oral placebo (identical matching placebo) during the study period.
干预措施: Placebo (Drug)
结局指标
主要结局
Alcohol Consumption (Percentage of Heavy Drinking Days)
时间窗: The percentage of heavy drinking days (HDD) was measured at each weekly visit during the 8 weeks.
The percentage of heavy drinking days was primary a priori outcome measure. Heavy drinking was defined as ≥ 5 standard drinks per day for men and ≥ 4 standard drinks for women. One standard drink is any drink containing about 0.6 fluid ounces or 14 grams of pure alcohol. The percentage of heavy drinking days (HDD) was measured at each weekly visit during the 8 weeks--from week 1 (before starting intervention) to week 9 (after completing intervention). At each week, the percentage of HDD was calculated during the period (usually 7 days) since the last previous visit.
次要结局
- The Penn Alcohol Craving Scale(The Penn Alcohol Craving Scale was measured at each weekly visit during the 8 weeks.)
- The Obsessive Compulsive Drinking Scale(The Obsessive Compulsive Drinking Scale was measured at each weekly visit during the 8 weeks.)
- Liver Function Tests(8 weeks)
研究者
Gihyun Yoon
Psychiatrist
Minneapolis Veterans Affairs Medical Center