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Efficacy of Baclofen in the Treatment of Alcohol Addiction

This study has been completed.
Sponsor:
Information provided by:
Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT00525252
First received: September 4, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00525252

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00525252     History of Changes
Other Study ID Numbers: Bacl001
Study First Received: September 4, 2007
Last Updated: September 4, 2007
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Liver Cirrhosis
Liver Cirrhosis, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Chemically-Induced Disorders
Digestive System Diseases
Liver Diseases
Liver Diseases, Alcoholic
Substance-Related Disorders

ClinicalTrials.gov processed this record on November 23, 2014