Baclofen as Add-On to Standard Treatment of Alcohol- Dependent Patients

Alcohol Dependence Clinical Trial

Official title:

Baclofen as Add-On to Standard Treatment of Alcohol- Dependent Patients and Its Effect on Quality of Life, Clinical and Psychosocial Features: A 12-Week Double-Blind Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01002105
• Other study ID #: AGRIN4CTIL
• Status: Recruiting
• Phase: Phase 4
• First received: October 19, 2009
• Last updated: August 5, 2010
• Start date: January 2010
• Est. completion date: December 2011

Study information

• Verified date: August 2010
• Source: Sha’ar Menashe Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This is a study of Baclofen as an add-on to standard treatment for alcohol-dependent patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

1. ICD-10 diagnosis of alcohol dependence (World Health Organization, 1993);

2. Seeking treatment with the aim to stop alcohol consumption;

3. Age ranging from 18 to 60 years;

4. Last alcohol intake reported in the 24 h preceding observation;

5. Presence of a referred family member;

6. Written informed consent provision.

Exclusion Criteria:.

1. Serious hepatic, kidney, lung, neurological and cardiovascular, diseases);

2. Suicide risk, acute psychosis, severe depression, organic brain syndromes;

3. Dependence on psychoactive substances other than nicotine.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Drug:
• Baclofen (as add-on to standard treatment of alcohol dependence)
Baclofen 30 mg per day for 12 weeks

Locations

Country	Name	City	State
Israel	Alexander Grinshpoon	Hadera

Sponsors (2)

Lead Sponsor	Collaborator
Sha’ar Menashe Mental Health Center	Ministry of Health, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical efficacy and safe side-effect profile of baclofen in patients suffering from alcohol dependence		one year	No
Primary	an improvement of the quality of life and associated psychosocial variables such as self-perceptions		one year	No