- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00525252
Efficacy of Baclofen in the Treatment of Alcohol Addiction
September 4, 2007 updated by: Catholic University of the Sacred Heart
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
86
Phase
- Phase 2
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
A total of 42 alcoholic patients with liver cirrhosis treated with 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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total alcohol abstinence; cumulative abstinence duration
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Obsessive and Compulsive craving
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Giovanni Addolorato, M.D., Catholic University of Rome
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2003
Study Completion (Actual)
November 1, 2006
Study Registration Dates
First Submitted
September 4, 2007
First Submitted That Met QC Criteria
September 4, 2007
First Posted (Estimate)
September 5, 2007
Study Record Updates
Last Update Posted (Estimate)
September 5, 2007
Last Update Submitted That Met QC Criteria
September 4, 2007
Last Verified
September 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Digestive System Diseases
- Pathologic Processes
- Alcohol-Related Disorders
- Substance-Related Disorders
- Liver Diseases
- Liver Diseases, Alcoholic
- Alcohol-Induced Disorders
- Fibrosis
- Liver Cirrhosis
- Liver Cirrhosis, Alcoholic
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- GABA Agents
- Neuromuscular Agents
- Muscle Relaxants, Central
- GABA Agonists
- GABA-B Receptor Agonists
- Baclofen
Other Study ID Numbers
- Bacl001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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