Status:
COMPLETED
Baclofen as Add-On to Standard Treatment of Alcohol- Dependent Patients
Lead Sponsor:
Sha'ar Menashe Mental Health Center
Collaborating Sponsors:
Ministry of Health, Israel
Conditions:
Alcohol Dependence
Eligibility:
All Genders
18-64 years
Phase:
PHASE4
Brief Summary
This is a study of Baclofen as an add-on to standard treatment for alcohol-dependent patients.
Detailed Description
Double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week ...
Eligibility Criteria
Inclusion
- ICD-10 diagnosis of alcohol dependence (World Health Organization, 1993);
- Seeking treatment with the aim to stop alcohol consumption;
- Age ranging from 18 to 60 years;
- Last alcohol intake reported in the 24 h preceding observation;
- Presence of a referred family member;
- Written informed consent provision.
Exclusion
- .
- Serious hepatic, kidney, lung, neurological and cardiovascular, diseases);
- Suicide risk, acute psychosis, severe depression, organic brain syndromes;
- Dependence on psychoactive substances other than nicotine.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT01002105
Start Date
January 1 2010
End Date
December 1 2012
Last Update
January 27 2017
Active Locations (1)
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1
Alexander Grinshpoon
Hadera, Israel, Mobil Post Hefer 37806