Efficacy of Baclofen in the Treatment of Alcohol Addiction
Primary Purpose
Liver Cirrhosis, Alcoholic
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Baclofen
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cirrhosis, Alcoholic focused on measuring Liver cirrhosis, Alcoholism, Craving
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
2
1
Arm Description
A total of 42 alcoholic patients with liver cirrhosis treated with placebo
a total of 42 alcoholic patients with liver cirrhosis treated by baclofen
Outcomes
Primary Outcome Measures
Total alcohol abstinence; cumulative abstinence duration
Secondary Outcome Measures
Obsessive and Compulsive craving
Full Information
NCT ID
NCT00525252
First Posted
September 4, 2007
Last Updated
September 4, 2007
Sponsor
Catholic University of the Sacred Heart
1. Study Identification
Unique Protocol Identification Number
NCT00525252
Brief Title
Efficacy of Baclofen in the Treatment of Alcohol Addiction
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 Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Catholic University of the Sacred Heart
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis, Alcoholic
Keywords
Liver cirrhosis, Alcoholism, Craving
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
86 (false)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
A total of 42 alcoholic patients with liver cirrhosis treated with placebo
Arm Title
1
Arm Type
Active Comparator
Arm Description
a total of 42 alcoholic patients with liver cirrhosis treated by baclofen
Intervention Type
Drug
Intervention Name(s)
Baclofen
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo will be orally administered for 12 consecutive weeks
Primary Outcome Measure Information:
Title
Total alcohol abstinence; cumulative abstinence duration
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Obsessive and Compulsive craving
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanni Addolorato, M.D.
Organizational Affiliation
Catholic University of Rome
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
12217947
Citation
Addolorato G, Caputo F, Capristo E, Domenicali M, Bernardi M, Janiri L, Agabio R, Colombo G, Gessa GL, Gasbarrini G. Baclofen efficacy in reducing alcohol craving and intake: a preliminary double-blind randomized controlled study. Alcohol Alcohol. 2002 Sep-Oct;37(5):504-8. doi: 10.1093/alcalc/37.5.504.
Results Reference
background
PubMed Identifier
18068515
Citation
Addolorato G, Leggio L, Ferrulli A, Cardone S, Vonghia L, Mirijello A, Abenavoli L, D'Angelo C, Caputo F, Zambon A, Haber PS, Gasbarrini G. Effectiveness and safety of baclofen for maintenance of alcohol abstinence in alcohol-dependent patients with liver cirrhosis: randomised, double-blind controlled study. Lancet. 2007 Dec 8;370(9603):1915-22. doi: 10.1016/S0140-6736(07)61814-5.
Results Reference
derived
Learn more about this trial
Efficacy of Baclofen in the Treatment of Alcohol Addiction
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