NCT01266655

Baclofen for the Treatment of Alcohol Dependence

Baclofen for the Treatment of Alcohol Dependence - BACLAD

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

There is first evidence from preclinical and clinical studies for the efficacy of the selective GABA-B receptor agonist baclofen in the treatment of alcohol dependence. The aim of this trial is to evaluate the efficacy and safety of individually titrated high-dose baclofen for relapse prevention in alcohol-dependent patients.

Conditions

• Alcohol Dependence

Interventions

Type	Name	Description
DRUG	Baclofen	Baclofen will be administered orally for a maximum of 20 consecutive weeks. For the first 3 days, patients will receive baclofen in a dose of 5 milligrams t.i.d.; subsequently, the daily dose of baclofen will be increased to a maximum of 90 milligrams t.i.d. within 4 weeks. In case of intolerance, dosage can be decreased to a minimum of 10 mg t.i.d.. Patients will receive maximum tolerated dosage of baclofen for 12 weeks. Medication will then gradually be tapered over a maximum of 4 weeks.
DRUG	Placebo	Placebo

Timeline

• Start date: 2011-02-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2010-12-24
• Last updated: 2014-09-05

Locations

1 site across 1 country: Germany