Exploring the Efficacy and Biobehavioural Basis of Baclofen in the Treatment of Alcoholic Liver Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- alcohol consumption
研究概览
简要总结
To explore the effectiveness and biobehavioural basis of baclofen in improving treatment outcomes for alcohol dependence in people with or without alcoholic cirrhosis in a double-blind randomised placebo-controlled trial.
详细描述
This is a double-blind randomised placebo-controlled study investigating the efficacy of baclofen for the treatment of alcohol dependence in patients with alcoholic liver disease. Medications will be given for 12 weeks, with a further 6 months follow-up. Both male and female participants will be recruited to this study. Trial patients will be randomised to one of three treatment groups: (1) baclofen 30mg/day (10 mg t.i.d), (2) baclofen 75mg/day (25 mg t.i.d) or (3) Placebo (3 matched tabs/day).
This study will also include a second, parallel group of patients with alcohol dependence (non alcoholic-liver disease patients) that will undergo the trial protocol as described above. These patients will be randomised according to a separate list into one of three treatment groups: (1) baclofen 30mg/day (10 mg t.i.d), (2) baclofen 75mg/day (25 mg t.i.d) or (3) Placebo (3 matched tabs/day).
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
- •ALD (for trial group 1), defined as the presence of symptoms and/or signs referable to liver disease with or without cirrhosis, in which alcohol use is considered to play a major aetiological role. Alcohol use will have exceeded an average of 60g/day in women and 80g/day in men for >10 years.
- •Alcohol dependence according to the ICD-10 criteria (for both trial 1 and 2)
- •Adequate cognition and English language skills to give valid consent and complete research interviews
- •Willingness to give written informed consent
- •Abstinence from alcohol for between 3 and 21 days
- •Resolution of any clinically evident alcohol withdrawal (CIWA-AR)
排除标准
- •Active major psychological disorder associated with psychosis or significant suicide risk
- •Pregnancy or lactation
- •Concurrent use of any psychotropic medication other than antidepressants
- •Substance use other than nicotine if unstable
- •Clinical evidence of persisting hepatic encephalopathy
- •Pending incarceration
- •Lack of stable housing
- •Active peptic ulcers
- •Unstable diabetes mellitus
研究组 & 干预措施
Arm 2
Baclofen high dose
干预措施: Baclofen 75mg/day (Drug)
Arm 1
Baclofen low dose
干预措施: Baclofen 30mg/day (Drug)
Arm 3
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
alcohol consumption
时间窗: 12 weeks
as measured by the number of days abstinent, number of heavy drinking days, time to relapse, time to lapse and number of drinks per drinking day
次要结局
- clinical markers of liver injury(12 weeks)
- incidence of hepatic side effects(12 weeks)
- craving for alcohol(12 weeks)
- early termination due to side effects(12 weeks)
研究者
Professor Paul Haber
Clinica Director
South West Sydney Local Health District