Conditions: Alcohol Dependence
Keywords: Baclofen Alcohol Baclofen as add-on to standard treatment of alcohol
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 75
Healthy volunteers: no

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.

Arms:
arm 1: 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. arm 2: Intervention of the addition of placebo to low-intensity psychosocial intervention program. This was the control group

Interventions: intervention 1: Baclofen intervention 2: Control group
Intervention descriptions: intervention 1: Baclofen 50mg per day for 12 weeks and psychosocial intervention intervention 2: psychosocial intervention and placebo for 12 weeks

Protocol document: