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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

September 4, 2007
September 4, 2007
February 2003
Not Provided
Total alcohol abstinence; cumulative abstinence duration [ Time Frame: 12 weeks ]
Same as current
No Changes Posted
Obsessive and Compulsive craving [ Time Frame: 12 weeks ]
Same as current
Not Provided
Not Provided
 
Efficacy of Baclofen in the Treatment of Alcohol Addiction
Maintaining Alcohol Abstinence in Alcoholic Patients With Liver Cirrhosis: Efficacy and Safety of Baclofen Administration in a Randomized Double Blind Controlled Study

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.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Liver Cirrhosis, Alcoholic
  • 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.
  • Drug: placebo
    Placebo will be orally administered for 12 consecutive weeks
  • Placebo Comparator: 2
    A total of 42 alcoholic patients with liver cirrhosis treated with placebo
    Intervention: Drug: placebo
  • Active Comparator: 1
    a total of 42 alcoholic patients with liver cirrhosis treated by baclofen
    Intervention: Drug: Baclofen

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
86
November 2006
Not Provided

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00525252
Bacl001
Yes
Not Provided
Catholic University of the Sacred Heart
Not Provided
Principal Investigator: Giovanni Addolorato, M.D. Catholic University of Rome
Catholic University of the Sacred Heart
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP