se of Baclofen (drug) in alcohol intake patients.
Phase 3
- Conditions
- Health Condition 1: K703- Alcoholic cirrhosis of liver
- Registration Number
- CTRI/2024/01/061476
- Lead Sponsor
- Institute of Liver and Biliary Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.All consecutive alcohol related compensated cirrhotic patients with continued alcohol consumption despite counselling in last 4 weeks aged between 18 - 65yrs
2.Fulfilling DSM – 5 criteria for alcohol use disorder (Association, 2013)
3.History of recent recidivism / relapse
Exclusion Criteria
1.Current HE
2.Total Bilirubin > 5 mg/dl
3.Recent bleed
4.Treatment with corticosteroids within the past 60 days
5.Unwilling to participate
6.Dependence on any other substance (except Nicotine)
7.Psychotic disorder requiring treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 weeksTimepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method To evaluate difference in alcohol free days between groups at 4, 8,12 and 24 weeksTimepoint: 4, 8,12 and 24 weeks;To evaluate difference in craving measures between groups at 4, 8,12 and 24 weeksTimepoint: 4, 8,12 and 24 weeks;To evaluate drinking pattern before and after 4 week on Naltrexone without liver related adverse effects compared to baclofenTimepoint: 4 weeks;To evaluate proportion of patients developing lapse and relapse in both the group at 4,8,12 and 24 weeksTimepoint: 4,8,12 and 24 weeks;To evaluate proportion of patients maintaining abstinence from alcohol in both the group at 24 weeksTimepoint: 24 weeks;To evaluate the progression of liver disease in both groupTimepoint: 24 weeks