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Efficacy of Baclofen in the Treatment of Alcohol Addiction

This study has been completed.
Information provided by:
Catholic University of the Sacred Heart Identifier:
First received: September 4, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted
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
Liver Cirrhosis, Alcoholic Drug: Baclofen Drug: placebo Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by Catholic University of the Sacred Heart:

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

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

Estimated Enrollment: 86
Study Start Date: February 2003
Study Completion Date: November 2006
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00525252

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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00525252     History of Changes
Other Study ID Numbers: Bacl001
Study First Received: September 4, 2007
Last Updated: September 4, 2007

Keywords provided by Catholic University of the Sacred Heart:
Liver cirrhosis

Additional relevant MeSH terms:
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 processed this record on August 16, 2017