Alcohol Dependence | Baclofen as Add-On to Standard Treatment of Alcohol- Dependent Patients
Alcohol Dependence research study
What is the primary objective of this study?
This is a study of Baclofen as an add-on to standard treatment for alcohol-dependent patients.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:BaclofenBaclofen 50mg per day for 12 weeks and psychosocial intervention
Other:Control grouppsychosocial intervention and placebo for 12 weeks
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
BaclofenThe study was a 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 follow-up observations.
Psychosocial interventionIntervention of the addition of placebo to low-intensity psychosocial intervention program. This was the control group
Start Date: January 2010
Completed Date: December 2012
Phase: Phase 4
Primary Outcome: Percent Abstinent Days
Secondary Outcome: Obsessive-Compulsive Drinking Scale Scores
Study sponsors, principal investigator, and references
Principal Investigator: Alexander M Ponizovsky, MD, PhD
Lead Sponsor: Sha’ar Menashe Mental Health Center
Collaborator: Ministry of Health, Israel