NCT01002105

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Sha'ar Menashe Mental Health Center · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alcohol Dependence

Interventions

Type	Name	Description
DRUG	Baclofen	Baclofen 50mg per day for 12 weeks and psychosocial intervention
OTHER	Control group	psychosocial intervention and placebo for 12 weeks

Timeline

• Start date: 2010-01-01
• Primary completion: 2012-05-01
• Completion: 2012-12-01
• First posted: 2009-10-27
• Last updated: 2017-01-27
• Results posted: 2017-01-27

Locations

1 site across 1 country: Israel