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Efficacy of Baclofen in the Treatment of Alcohol Addiction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00525252
Recruitment Status : Completed
First Posted : September 5, 2007
Last Update Posted : September 5, 2007
Information provided by:
Catholic University of the Sacred Heart

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.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis, Alcoholic Drug: Baclofen Drug: placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Maintaining Alcohol Abstinence in Alcoholic Patients With Liver Cirrhosis: Efficacy and Safety of Baclofen Administration in a Randomized Double Blind Controlled Study
Study Start Date : February 2003
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis
Drug Information available for: Baclofen

Arm Intervention/treatment
Placebo Comparator: 2
A total of 42 alcoholic patients with liver cirrhosis treated with placebo
Drug: placebo
Placebo will be orally administered for 12 consecutive weeks

Active Comparator: 1
a total of 42 alcoholic patients with liver cirrhosis treated by baclofen
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.

Primary Outcome Measures :
  1. Total alcohol abstinence; cumulative abstinence duration [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Obsessive and Compulsive craving [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • age ranging from 18 to 75 years
  • diagnosis of alcohol dependence according to DSM IV criteria
  • diagnosis of liver cirrhosis
  • alcohol intake of at least 2 heavy drinking days (men > 5 drinks/days; women > 4 drinks/day) per week, on average and an average overall consumption of 21 drinks/week or more for men and 14 drinks/week or more for women during the 4 weeks prior to enrolment
  • presence of a referred family member

Exclusion Criteria:

  • severe heart or lung disease
  • kidney alterations and/or hepato-renal syndrome
  • tumours, including hepatocellular carcinoma
  • metabolic diseases, including diabetes
  • clinical signs of hepatic encephalopathy
  • patients treated with interferon or corticosteroids within the last 60 days
  • psychopathological illness undergoing treatment with psychoactive drugs
  • epilepsy or epileptiform convulsions
  • addiction to drugs other than nicotine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00525252

Sponsors and Collaborators
Catholic University of the Sacred Heart
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Principal Investigator: Giovanni Addolorato, M.D. Catholic University of Rome

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00525252    
Other Study ID Numbers: Bacl001
First Posted: September 5, 2007    Key Record Dates
Last Update Posted: September 5, 2007
Last Verified: September 2007
Keywords provided by Catholic University of the Sacred Heart:
Liver cirrhosis
Additional relevant MeSH terms:
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Liver Cirrhosis
Liver Cirrhosis, Alcoholic
Pathologic Processes
Liver Diseases
Digestive System Diseases
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders