Effect of Naltrexone in Achieving and Maintaining Abstinence From Alcohol in Patients With Cirrhosis- A Double Blind Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Proportion of patients achieving and maintaining alcohol abstinence at 12 weeks in both groups
研究概览
简要总结
The aim of the study is to study the safety and tolerability of Naltrexone in patients with Alcohol liver disease over a 12 week duration without liver related side effects. The project will be conducted at ILBS from March 2020 to February 2021. The concept is to estimate the usage of naltrexone and establish its safety in cirrhotics and study its effect on achieving and maintaining abstinence and in reducing lapses and relapses. Thereby reducing the progression of alcoholic liver disease as continued ethanol consumption is an important predictor in increasing overall morbidity and mortality.
All ALD patients will be included as per inclusion and exclusion criteria, after taking informed consent from the patient or their relatives. In case of any reactions, the drug will be stopped as per the study stopping rule.
After following the inclusion and exclusion criteria, ALD patients will be recruited into the study. It's a double blind RCT, hence both the patient and the investigator will be blinded and the drug will be issued by the trial co-ordinator after taking informed written consent and explaining the side effects. Naltrexone at a dose of 50 mg per day and placebo are included in the tablets. Placebo tablets will be identical in size, colour, shape, and taste. Naltrexone tablets will be entrusted to a family member to administer every dose and monitor for side effects.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All consecutive alcohol dependent cirrhotic aged between 18-60 yrs.
- •Fulfilling DSM - 5 criteria for alcohol use disorder (Association, 2013).
排除标准
- •Current Hepatic Encephalopathy
- •Total Bilirubin > 3 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/Suicidal tendency.
研究组 & 干预措施
Naltrexone
Naltrexone at a dose of 50 mg per day.
干预措施: Naltrexone (Drug)
Placebo
Placebo tablets will be identical in size, colour, shape, and taste and will be given in a similar manner.
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Proportion of patients achieving and maintaining alcohol abstinence at 12 weeks in both groups
时间窗: 12 weeks
次要结局
- Proportion of patients on Naltrexone without liver related adverse effects as compared to placebo(12 weeks)
- difference in craving measures between groups at 4 weeks in both groups(4 weeks)
- Proportion of patients maintaining abstinence from alcohol at 12 months in both groups(12 months)
- difference in craving measures between both groups at 8 weeks.(8 weeks)
- difference in craving measures between both groups at 12 weeks.(12 weeks)
- difference in craving measures between both groups at 12 months.(12 months)
- Proportion of patients maintaining abstinence from alcohol at 6 months in both groups(6 months)
- difference in craving measures between both groups at 6 months.(6 months)