Clinical Trial: Efficacy of Baclofen in the Treatment of Alcohol Addiction
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Maintaining Alcohol Abstinence in Alcoholic Patients With Liver Cirrhosis: Efficacy and Safety of Baclofen Administration in a Randomized Double Blind Controlled Study
Brief Summary: Intervention to achieve alcohol abstinence represents the most effective treatment for alcoholic patients with liver cirrhosis. However no trials have evaluated the efficacy of anti-craving drugs in these patients because of the concern that these medications might worsen liver disease. Baclofen is effective to reduce alcohol craving improving abstinence in alcohol-dependent patients. It is mainly eliminated by kidney. No hepatic side-effects have been reported in treated patients. The present study investigates the efficacy and safety of baclofen in achieving and maintaining abstinence in alcoholic cirrhotic patients.
Detailed Summary:
Sponsor: Catholic University of the Sacred Heart
Current Primary Outcome: Total alcohol abstinence; cumulative abstinence duration [ Time Frame: 12 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Obsessive and Compulsive craving [ Time Frame: 12 weeks ]
Original Secondary Outcome: Same as current
Information By: Catholic University of the Sacred Heart
Dates:
Date Received: September 4, 2007
Date Started: February 2003
Date Completion:
Last Updated: September 4, 2007
Last Verified: September 2007