Efficacy of Baclofen Vs Naltrexon in Achieving & Maintaining Abstinence in Alcohol Dependence.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- The comparison in the proportion of patients achieving and maintaining alcohol abstinence between Naltrexone and Baclofen in alcohol associated liver cirrhosis patients with continued alcohol intake at 12 weeks
研究概览
简要总结
ALD is the most common cause of liver cirrhosis in western world. In patients with ALD persistent alcohol intake is associated with increased mortality while cessation of alcohol consumption improve survival. Baclofen is GABA-B receptor agonist and it is safe in cirrhotic patient for alcohol abstinence i.e. already proven and naltrexone is Delta and k-opioid receptor antagonist and it is safe in cirrhotic for alcohol abstinence i.e, proven in ILBS.
详细描述
Aim and Objective:
• To compare the efficacy of Naltrexone Vs Baclofen in achieving and maintaining 12-week abstinence in patients with alcohol associated liver cirrhosis with continued alcohol use
Primary objective:
-
The comparison in the proportion of patients achieving and maintaining alcohol abstinence between Naltrexone and Baclofen in alcohol associated liver cirrhosis patients with continued alcohol intake at 12 weeks
-
Secondary objectives:
-
To evaluate drinking pattern before and after 4 week on Naltrexone without liver related adverse effects compared to baclofen
-
To evaluate proportion of patients maintaining abstinence from alcohol in both the group at 24 weeks
-
To evaluate difference in craving measures between groups at 4, 8,12 and 24 weeks
-
To evaluate difference in alcohol free days between groups at 4, 8,12 and 24 weeks
-
To evaluate proportion of patients developing lapse and relapse in both the group at 4,8,12 and 24 weeks
-
To evaluate the progression of liver disease in both group
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
- None
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
- •All consecutive alcohol related compensated cirrhotic patients with continued alcohol consumption despite counselling in last 4 weeks aged between 18 - 65yrs
- •Fulfilling DSM - 5 criteria for alcohol use disorder (Association, 2013)
- •History of recent recidivism / relapse
排除标准
- •Total Bilirubin > 5 mg/dl
- •Recent bleed
- •Treatment with corticosteroids within the past 60 days
- •Unwilling to participate
- •Dependence on any other substance (except Nicotine)
- •Psychotic disorder requiring treatment
研究组 & 干预措施
Naltrexone
Naltrexone 50mg orally once daily will give for 12 weeks
干预措施: Naltrexon (Drug)
Baclofen
Baclofen 10mg orally thrice daily will give for 12 weeks
干预措施: Baclofen (Drug)
结局指标
主要结局
The comparison in the proportion of patients achieving and maintaining alcohol abstinence between Naltrexone and Baclofen in alcohol associated liver cirrhosis patients with continued alcohol intake at 12 weeks
时间窗: 12 weeks
次要结局
- To evaluate proportion of patients maintaining abstinence from alcohol in both the group at 24 weeks(24 weeks)
- To evaluate the progression of liver disease in both group at 24weeks by measuring Child pugh score.(24 weeks)
- To evaluate abstinence rate by OCDS score in both the group (OCDS- Obsessive compulsive drinking scale 0-40, Higher total score indicate more obsessive thoughts or compulsive behaviour regarding alcohol use)(4 weeks)
- To evaluate difference in alcohol free days between groups at 4, 8,12 and 24 weeks(4, 8,12 and 24 weeks)
- To evaluate proportion of patients developing lapse and relapse in both the group at 4,8,12 and 24 weeks(4,8,12 and 24 weeks)
- To evaluate difference in craving measures between groups at 4,8,12 and 24 weeks.(4, 8,12 and 24 weeks)