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
Overview
- Phase
- Phase 4
- Intervention
- Baclofen
- Conditions
- Alcohol Dependence
- Sponsor
- Sha'ar Menashe Mental Health Center
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Percent Abstinent Days
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This is a study of Baclofen as an add-on to standard treatment for alcohol-dependent patients.
Detailed Description
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. The percentages of heavy drinking days and abstinent days were the primary outcome measures, and craving; distress and depression levels; self-efficacy; social support from family, friends and significant others; and health-related quality of life (HRQL) were secondary outcomes. Tolerability was also examined.
Investigators
Alexander Grinshpoon
Dr. Alexander Grinshpoon
Sha'ar Menashe Mental Health Center
Eligibility Criteria
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.
Arms & Interventions
Baclofen
The 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.
Intervention: Baclofen
Psychosocial intervention
Intervention of the addition of placebo to low-intensity psychosocial intervention program. This was the control group
Intervention: Control group
Outcomes
Primary Outcomes
Percent Abstinent Days
Time Frame: one year
Percent abstinent days at 52 weeks. % of abstinent days were assessed by (1) patient's self-evaluation; (2) family member interview; (3) calculation of cumulative abstinence duration (CAD), defined as the total number of days of abstinence, Abstinent days was calculated for each Arm as a whole.
Secondary Outcomes
- Obsessive-Compulsive Drinking Scale Scores(baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks)
- General Health Questionnaire(baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks)
- General Self-Efficacy Scale(baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks)
- Multidimensional Scale of Perceived Social Support(Baseline, 52 weeks)
- Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)(baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks)