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Clinical trial

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

ID
Name
ILBS-ALD-02
Description
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.
Trial arms
Trial start
2023-12-25
Estimated PCD
2025-03-31
Trial end
2025-03-31
Status
Not yet recruiting
Treatment
Naltrexon
Naltrexone 50mg orally once daily will give for 12 weeks
Arms:
Naltrexone
Baclofen
Baclofen 10mg orally thrice daily will give for 12 weeks
Arms:
Baclofen
Size
110
Primary endpoint
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 weeks
12 weeks
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 110, 'type': 'ESTIMATED'}}
Updated at
2023-12-19

1 organization

2 products

1 indication

Organization
Institute of Liver and Biliary Sciences
Product
Naltrexon
Indication
Alcoholic Liver Disease
Product
Baclofen