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Sponsored by: |
Catholic University of the Sacred Heart |
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Information provided by: | Catholic University of the Sacred Heart |
ClinicalTrials.gov Identifier: | NCT00525252 |
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.
Condition | Intervention | Phase |
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Liver Cirrhosis, Alcoholic |
Drug: Baclofen Drug: placebo |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Maintaining Alcohol Abstinence in Alcoholic Patients With Liver Cirrhosis: Efficacy and Safety of Baclofen Administration in a Randomized Double Blind Controlled Study |
Estimated Enrollment: | 86 |
Study Start Date: | February 2003 |
Study Completion Date: | November 2006 |
Arms | Assigned Interventions |
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2: Placebo Comparator
A total of 42 alcoholic patients with liver cirrhosis treated with placebo
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Drug: placebo
Placebo will be orally administered for 12 consecutive weeks
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1: Active Comparator
a total of 42 alcoholic patients with liver cirrhosis treated by baclofen
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Drug: Baclofen
Baclofen orally administered for 12 consecutive weeks. For the first 3 days, baclofen administered at a dose of 5 milligrams 3 times per day; subsequently, the daily dose of baclofen will be increased to 10 milligrams 3 times per day.
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | Bacl001 |
Study First Received: | September 4, 2007 |
Last Updated: | September 4, 2007 |
ClinicalTrials.gov Identifier: | NCT00525252 |
Health Authority: | Italy: Ethics Committee |
Liver cirrhosis Alcoholism Craving |
Alcohol-Induced Disorders Behavior, Addictive Liver Diseases Fibrosis Baclofen Disorders of Environmental Origin Liver Cirrhosis |
Liver Diseases, Alcoholic Digestive System Diseases Alcoholism Substance-Related Disorders Alcohol-Related Disorders Liver Cirrhosis, Alcoholic Ethanol |
Neurotransmitter Agents Pathologic Processes Molecular Mechanisms of Pharmacological Action GABA Agonists Therapeutic Uses Muscle Relaxants, Central |
Physiological Effects of Drugs GABA Agents Neuromuscular Agents Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions |