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

Launched by INSTITUTE OF LIVER AND BILIARY SCIENCES, INDIA · Dec 18, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating two medications, Baclofen and Naltrexone, to see which one is more effective in helping people with alcohol dependence stop drinking and stay sober. The study focuses on patients who have alcohol-related liver disease, a serious condition that can lead to liver damage and even death if alcohol consumption continues. Both Baclofen and Naltrexone have been shown to be safe for individuals with liver issues, and the trial aims to determine which medication can better help patients achieve and maintain abstinence from alcohol.

To participate in this trial, individuals must be between 18 and 65 years old and have been diagnosed with alcohol use disorder. They should also have been drinking alcohol despite receiving counseling in the last month and have experienced recent relapses. However, those with certain health issues, such as severe liver problems, recent bleeding, or those taking specific medications, won't be eligible to join. Participants can expect to receive either Baclofen or Naltrexone during the study and will be monitored for their progress in achieving sobriety. This trial is important because it aims to find effective treatment options for people struggling with alcohol dependence and liver disease.

Gender

ALL

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