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Effect of Naltrexone (Drug) in Patients With Cirrhosis with alcohol problem.

Effect of Naltrexone in Achieving and Maintaining Abstinence From Alcohol in Patients With Cirrhosis- A Double Blind Randomized Controlled Trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/05/025417
Enrollment
100
Registered
2020-05-28
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K703- Alcoholic cirrhosis of liver

Interventions

Intervention1: Naltrexone: Naltrexone orally will be given at a dose of 50 mg per day for 12 weeks Control Intervention1: Placebo: Placebo tablets 1 OD , orally for 12 weeks (It will be identical in s

Sponsors

Institute of Liver and Biliary Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All consecutive alcohol dependent cirrhotic aged between 18-60 yrs. 2. Fulfilling DSM - 5 criteria for alcohol use disorder (Association, 2013).

Exclusion criteria

Exclusion criteria: 1. Current Hepatic Encephalopathy 2. Total Bilirubin > 3 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/Suicidal tendency.

Design outcomes

Primary

MeasureTime frame
Proportion of patients achieving and maintaining alcohol abstinence at 12 weeksTimepoint: 12 weeks—

Secondary

MeasureTime frame
difference in craving measures between groupsTimepoint: 4,8,12 weeks,6 months & 12 months;Proportion of patients maintaining abstinence from alcohol in both groupsTimepoint: 6 & 12 months;Proportion of patients on Naltrexone without liver related adverse effects as compared to placeboTimepoint: 12 weeks—

Countries

India

Contacts

Public ContactDr Shasthry SM

Institute of Liver and Biliary Sciences

shasthry@gmail.com01146300000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026