NCT00302133

Optimizing Pharmacotherapy for Bipolar Alcoholics

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to test the efficacy of naltrexone and valproate in the treatment of comorbid bipolar disorder and alcohol dependence.

Detailed description

Bipolar disorder has the highest rate of association with alcohol and other substance use disorders. This complex clinical presentation is asociated with severe disabilities,morbidity and heightened risk for suicide. There is a significant gap in our knowledge regarding effective treatment interventions for this high risk clinical population. This proposal will test the efficacy of a promising pharmacological approach for the treatment of comorbid alcohol dependence and bipolar disorder. We propose a randomized, double blind, placebo controlled 12-week trial to test the efficacy of valproate plus naltrexone vs. valproate alone in decreasing alcohol use and stabilizing mood symptoms among patients with comorbid alcohol dependence and bipolar disorder. All participants receive supportive psychosocial treatment.

Conditions

• Bipolar Disorder
• Alcohol Dependence

Interventions

Type	Name	Description
DRUG	Naltrexone hydrochloride	Naltrexone hydrochloride 50 mg capsule daily for 12 weeks
OTHER	Placebo	Placebo arm

Timeline

• Start date: 2006-05-01
• Primary completion: 2013-04-01
• Completion: 2013-07-01
• First posted: 2006-03-13
• Last updated: 2016-05-17
• Results posted: 2014-11-05

Locations

1 site across 1 country: United States