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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:

MedlinePlus related topics: Alcoholism Cirrhosis
Drug Information available for: Baclofen
U.S. FDA Resources

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
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
Fibrosis
Liver Cirrhosis, Alcoholic
Liver Diseases
Digestive System Diseases
Pathologic Processes
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Baclofen
GABA-B Receptor Agonists
 GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Muscle Relaxants, Central
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013