Health Condition 1: K703- Alcoholic cirrhosis of liver
Conditions
Interventions
Intervention1: Naltrexone: Naltrexone 50mg orally once daily will give for 12 weeks
Control Intervention1: Baclofen: Baclofen 10mg orally thrice daily will give for 12 weeks
Sponsors
Institute of Liver and Biliary Sciences
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr Shasthry S M
Institute of Liver and Biliary Sciences
Outcome results
None listed