Status:
COMPLETED
Effect of Naltrexone in Achieving and Maintaining Abstinence From Alcohol in Patients With Cirrhosis.
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Liver Cirrhosis
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
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 conduc...
Eligibility Criteria
Inclusion
- All consecutive alcohol dependent cirrhotic aged between 18-60 yrs.
- Fulfilling DSM - 5 criteria for alcohol use disorder (Association, 2013).
Exclusion
- 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.
Key Trial Info
Start Date :
December 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04391764
Start Date
December 6 2020
End Date
October 31 2022
Last Update
March 28 2023
Active Locations (1)
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1
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India, 110070