N-acetylcysteine Plus Naltrexone for the Treatment of Alcohol Dependence
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 2
- 主要终点
- Percentage of Heavy Drinking Days
研究概览
简要总结
The purpose of this study is to determine whether: (1) the combination of N-acetylcysteine + high-dose naltrexone (150 mg) works better than high-dose naltrexone (150 mg) alone in reducing alcohol drinking; and (2) high-dose naltrexone (150 mg) alone works better than low-dose naltrexone (50 mg) alone in reducing alcohol drinking.
详细描述
The 3 groups (N-acetylcysteine plus naltrexone 150 mg, naltrexone 150 mg, and naltrexone 50 mg) will be compared in a 12-week randomized, double-blind clinical trial.
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 years
- •alcohol dependence by DSM-IV criteria
- •heavy drinking at least 6 times within the past month ('heavy drinking' defined as 5 or more standard drinks per day for men and 4 or more standard drinks for women)
- •able to provide informed consent
- •a score of 6 or more on the Penn Alcohol Craving Scale (PACS)
- •subject agrees not to take over-the-counter analgesics during the study
排除标准
- •current drug abuse or dependence by DSM-IV criteria (except nicotine and marijuana)
- •current psychotic disorders or bipolar disorders
- •current suicidal or homicidal ideation
- •positive illicit drug screen test (except marijuana)
- •ongoing narcotic use or risks for narcotic use during the study
- •increased risk for severe alcohol withdrawal by a score of 10 or more on the Clinical Institute Withdrawal Assessment for Alcohol, Revised (CIWA-Ar)
- •clinically significant cardiac, hepatic, renal, neurologic, or pulmonary disease
- •baseline aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 3 times normal
- •current use of disulfiram, acamprosate or topiramate
- •pregnant or nursing, or inadequate birth control methods in women of childbearing potential
- •alcohol breathalyzer level 0.08 or more at the screening visit
- •severe alcohol withdrawal (delirium tremens or withdrawal seizures) within the past year
- •currently requiring inpatient treatment for treating alcohol dependence
研究组 & 干预措施
Arm 2
High-dose naltrexone (150 mg) alone
干预措施: High-dose naltrexone (150 mg) alone (Drug)
Arm 1
N-acetylcysteine + high-dose naltrexone (150 mg)
干预措施: N-acetylcysteine + high-dose naltrexone (150 mg) (Drug)
Arm 3
Low-dose naltrexone (50 mg) alone
干预措施: Low-dose naltrexone (50 mg) alone (Drug)
结局指标
主要结局
Percentage of Heavy Drinking Days
时间窗: week 1 and week 13
"Percentage of heavy drinking days" was measured by the Time Line Follow Back (TLFB) Method. ('Heavy drinking' was defined as 5 or more standard drinks per day for men and 4 or more standard drinks for women.) The percentage has a total range of 0%-100%. Higher percentages represent a worse outcome (i.e., more heavy drinking).
次要结局
- Liver Function Tests (ALT)(week 0 and week 13)
- Liver Function Tests (AST)(week 0 and week 13)
- Clinical Global Impression (CGI)(week 1 and week 13)
- Percentage of Drinking Days(week 1 and week 13)
- Penn Alcohol Craving Scale (PACS)(week 1 and week 13)
- Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)(week 1 and week 13)
- Drinks Per Drinking Days(week 1 and week 13)
- Obsessive Compulsive Drinking Scale (OCDS)(week 1 and week 13)