Maintaining Alcohol Abstinence in Alcoholic Patients With Liver Cirrhosis: Efficacy and Safety of Baclofen Administration in a Randomized Double Blind Controlled Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 86
- 主要终点
- Total alcohol abstinence; cumulative abstinence duration
研究概览
简要总结
Intervention to achieve alcohol abstinence represents the most effective treatment for alcoholic patients with liver cirrhosis. However no trials have evaluated the efficacy of anti-craving drugs in these patients because of the concern that these medications might worsen liver disease. Baclofen is effective to reduce alcohol craving improving abstinence in alcohol-dependent patients. It is mainly eliminated by kidney. No hepatic side-effects have been reported in treated patients. The present study investigates the efficacy and safety of baclofen in achieving and maintaining abstinence in alcoholic cirrhotic patients.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ranging from 18 to 75 years
- •diagnosis of alcohol dependence according to DSM IV criteria
- •diagnosis of liver cirrhosis
- •alcohol intake of at least 2 heavy drinking days (men > 5 drinks/days; women > 4 drinks/day) per week, on average and an average overall consumption of 21 drinks/week or more for men and 14 drinks/week or more for women during the 4 weeks prior to enrolment
- •presence of a referred family member
排除标准
- •severe heart or lung disease
- •kidney alterations and/or hepato-renal syndrome
- •tumours, including hepatocellular carcinoma
- •metabolic diseases, including diabetes
- •clinical signs of hepatic encephalopathy
- •patients treated with interferon or corticosteroids within the last 60 days
- •psychopathological illness undergoing treatment with psychoactive drugs
- •epilepsy or epileptiform convulsions
- •addiction to drugs other than nicotine
研究组 & 干预措施
2
A total of 42 alcoholic patients with liver cirrhosis treated with placebo
干预措施: placebo (Drug)
1
a total of 42 alcoholic patients with liver cirrhosis treated by baclofen
干预措施: Baclofen (Drug)
结局指标
主要结局
Total alcohol abstinence; cumulative abstinence duration
时间窗: 12 weeks
次要结局
- Obsessive and Compulsive craving(12 weeks)