Overview

Efficacy of Baclofen Vs Naltrexon in Achieving & Maintaining Abstinence in Alcohol Dependence.

Status:
Not yet recruiting
Trial end date:
2025-03-31
Target enrollment:
0
Participant gender:
All
Summary
ALD is the most common cause of liver cirrhosis in western world. In patients with ALD persistent alcohol intake is associated with increased mortality while cessation of alcohol consumption improve survival. Baclofen is GABA-B receptor agonist and it is safe in cirrhotic patient for alcohol abstinence i.e. already proven and naltrexone is Delta and k-opioid receptor antagonist and it is safe in cirrhotic for alcohol abstinence i.e, proven in ILBS.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Treatments:
Baclofen
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:

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