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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?

Alcohol Dependence

Study Interventions

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

Study Arms

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

Study Status

Completed

Start Date: January 2010

Completed Date: December 2012

Phase: Phase 4

Type: Interventional

Design:

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

More information:https://clinicaltrials.gov/show/NCT01002105

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