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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified August 2010 by Sha’ar Menashe Mental Health Center.
Recruitment status was Recruiting

Sponsor:

Collaborator:

Ministry of Health, Israel

Information provided by:

Sha’ar Menashe Mental Health Center

ClinicalTrials.gov Identifier:

NCT01002105

First received: October 19, 2009

Last updated: August 5, 2010

Last verified: August 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

October 19, 2009

Last Updated Date

August 5, 2010

Start Date ^ICMJE

January 2010

Estimated Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

clinical efficacy and safe side-effect profile of baclofen in patients suffering from alcohol dependence [ Time Frame: one year ] [ Designated as safety issue: No ]
an improvement of the quality of life and associated psychosocial variables such as self-perceptions [ Time Frame: one year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01002105 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Alcohol Dependence

Intervention ^ICMJE

Drug: Baclofen (as add-on to standard treatment of alcohol dependence)

Baclofen 30 mg per day for 12 weeks

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

120

Estimated Completion Date

December 2011

Estimated Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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 Criteria:.

Serious hepatic, kidney, lung, neurological and cardiovascular, diseases);
Suicide risk, acute psychosis, severe depression, organic brain syndromes;
Dependence on psychoactive substances other than nicotine.

Gender

Both

Ages

18 Years to 64 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

Israel

Administrative Information

NCT Number ^ICMJE

NCT01002105

Other Study ID Numbers ^ICMJE

AGRIN4CTIL

Has Data Monitoring Committee

Yes

Responsible Party

director sha'ar menashe mhc, sha'ar menashe mhc

Study Sponsor ^ICMJE

Sha’ar Menashe Mental Health Center

Collaborators ^ICMJE

Ministry of Health, Israel

Investigators ^ICMJE

Study Director:

Alexander M Ponizovsky, MD, PhD

Ministry of health, State of Israel

Information Provided By

Sha’ar Menashe Mental Health Center

Verification Date

August 2010

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

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