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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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
  Purpose
This is a study of Baclofen as an add-on to standard treatment for alcohol-dependent patients.

Condition Intervention Phase
Alcohol Dependence
Drug: Baclofen (as add-on to standard treatment of alcohol dependence)
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Sha’ar Menashe Mental Health Center:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: January 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Baclofen (as add-on to standard treatment of alcohol dependence)
    Baclofen 30 mg per day for 12 weeks
  Eligibility

Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01002105

Locations
Israel
Alexander Grinshpoon
Hadera, Israel, Mobil Post Hefer 37806
Sponsors and Collaborators
Sha’ar Menashe Mental Health Center
Ministry of Health, Israel
Investigators
Study Director: Alexander M Ponizovsky, MD, PhD Ministry of health, State of Israel
  More Information

Responsible Party: director sha'ar menashe mhc, sha'ar menashe mhc
ClinicalTrials.gov Identifier: NCT01002105     History of Changes
Other Study ID Numbers: AGRIN4CTIL 
Study First Received: October 19, 2009
Last Updated: August 5, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Sha’ar Menashe Mental Health Center:
Baclofen
Alcohol
Baclofen as add-on to standard treatment of alcohol

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 02, 2016