The Role of Pharmacotherapy in Prevention of Relapse in Alcohol Dependence
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Time (days) to relapse
研究概览
简要总结
The purpose of this study is to compare the effectiveness of two anti-craving medications, naltrexone versus acamprosate, in the treatment of alcohol dependence.
详细描述
The physical, psychological and social consequences of alcohol abuse remain a critical health problem. Every year in Australia, excessive consumption is responsible for 3,000 - 6,000 deaths and costs the community $6 billion. Approximately 15% of Australians abuse alcohol and 5% of men and 3% of women are alcohol dependent (addicted to alcohol). Better treatment for alcohol dependence is urgently needed. Treatment for alcohol dependence remains unsatisfactory. Most treatments lead to abstinence in only 1 out of 3 cases, and approximately 50% of these will relapse within 3 months of completing treatment. Two drugs (naltrexone and acamprosate) appear to interfere with the effects of alcohol on the brain that promote addiction. There is evidence that both drugs are beneficial in the treatment of alcohol dependence and both are now available in Australia. At present, no data have been reported comparing the effectiveness of these two drugs. The proposed project will compare naltrexone and acamprosate in a large, carefully performed, study. The study will help determine which subjects are likely to benefit from one or the other of these agents.
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
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
- •Alcohol dependence according to the ICD10 criteria, with alcohol as the subject's drug of choice
- •Ages 18-65
- •Adequate cognition and English language skills to give valid consent and complete research interviews (as assessed by MMSE)
- •Willingness to give written informed consent
- •Abstinence from alcohol for between 3 and 21 days, and resolution of any clinically evident alcohol withdrawal
排除标准
- •Opiate abuse within the last one month
- •Sensitivity to study medications or therapy with these drugs within 6 months
- •Active major psychiatric disorder associated with psychosis or significant suicide risk
- •Pregnancy or lactation
- •Advanced decompensated liver disease (hepatocellular failure, variceal bleeding, ascites or encephalopathy)
结局指标
主要结局
Time (days) to relapse
Time (days) to lapse
Days abstinence
Drinks per drinking day
Biochemical measures of liver function
次要结局
- Anxiety
- Depression
- Global physical health
- Craving
- Stress
- Global mental health
