NCT01711125

Baclofen in the Treatment of Alcohol Dependence With or Without Alcoholic Liver Disease

Exploring the Efficacy and Biobehavioural Basis of Baclofen in the Treatment of Alcoholic Liver Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: South West Sydney Local Health District · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To explore the effectiveness and biobehavioural basis of baclofen in improving treatment outcomes for alcohol dependence in people with or without alcoholic cirrhosis in a double-blind randomised placebo-controlled trial.

Detailed description

This is a double-blind randomised placebo-controlled study investigating the efficacy of baclofen for the treatment of alcohol dependence in patients with alcoholic liver disease. Medications will be given for 12 weeks, with a further 6 months follow-up. Both male and female participants will be recruited to this study. Trial patients will be randomised to one of three treatment groups: (1) baclofen 30mg/day (10 mg t.i.d), (2) baclofen 75mg/day (25 mg t.i.d) or (3) Placebo (3 matched tabs/day). This study will also include a second, parallel group of patients with alcohol dependence (non alcoholic-liver disease patients) that will undergo the trial protocol as described above. These patients will be randomised according to a separate list into one of three treatment groups: (1) baclofen 30mg/day (10 mg t.i.d), (2) baclofen 75mg/day (25 mg t.i.d) or (3) Placebo (3 matched tabs/day).

Conditions

• Alcoholic Liver Disease
• Alcohol Dependence

Interventions

Type	Name	Description
DRUG	Baclofen 30mg/day	30mg/day 10 mg t.i.d
DRUG	Baclofen 75mg/day	75mg/day 25 mg t.i.d
DRUG	Placebo	Placebo 3 matched tabs/day

Timeline

• Start date: 2013-03-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2012-10-22
• Last updated: 2017-08-08

Locations

1 site across 1 country: Australia