NCT00466661

Acamprosate vs. Placebo in Bipolar Alcoholics

A Double-Blind, Randomized, Placebo-Controlled Trial of Acamprosate in Alcohol-Dependent Individuals With Comorbid Bipolar Disorder

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To conduct a double-blind, randomized, placebo-controlled outpatient clinical trial of acamprosate in individuals with alcohol dependence and bipolar disorder who are also receiving mood stabilizing medication. The study will assess the safety and efficacy of acamprosate in alcohol-dependent bipolar patients as measured by its effects on alcohol use and mood symptoms relative to placebo. The primary hypothesis to be tested is whether individuals with comorbid bipolar disorder and alcohol dependence who receive acamprosate plus mood stabilizer will have greater improvement in alcohol-related outcomes than those who receive mood stabilizer alone. A secondary hypothesis that will be explored is that alcohol-dependent bipolar individuals treated with acamprosate will have greater mood stability as compared to those treated with mood stabilizers alone.

Conditions

• Alcohol Dependence
• Bipolar Disorder

Interventions

Type	Name	Description
DRUG	Acamprosate	666 mg po TID
DRUG	Placebo	2 tabs po TID

Timeline

• Start date: 2007-04-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2007-04-27
• Last updated: 2018-12-14
• Results posted: 2018-12-14

Locations

1 site across 1 country: United States