NCT00240110

Valproate Efficacy in Cocaine-Bipolar Comorbidity

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This proposal will test the efficacy of a promising pharmacological approach for the treatment of comorbid cocaine dependence and bipolar disorder. We propose a randomized, double blind, placebo controlled 12-week trial to test the efficacy of Divalproex sodium (Valproate) plus treatment as usual compared to placebo plus treatment as usual in decreasing cocaine use and stabilizing mood symptoms among patients with comorbid cocaine dependence and bipolar disorder. Treatment as usual includes the use of lithium carbonate for mood stabilization plus supportive psychosocial treatment.

Detailed description

Bipolar disorder has the highest rate of association with cocaine and other substance use disorders than any other major severe psychiatric syndrome. This comorbidity represents a major treatment challenge and is associated with severe disability, morbidity, and heightened risk for suicide. The aims of this study are: 1. Examine the efficacy of valproate plus treatment as usual compared to placebo plus treatment as usual in decreasing cocaine use in patients with cocaine dependence and comorbid bipolar disorder. 2. Determine whether primary vs. secondary cocaine dependence, bipolar subtype (depressed vs. manic/mixed) and the presence of additional substance use disorders moderate the association between treatment and cocaine use outcome. 3. Assess the effects of medication compliance and mood symptoms as mediators of cocaine use outcome.

Conditions

• Bipolar Disorder
• Cocaine Dependence

Interventions

Type	Name	Description
DRUG	Valproate	Valproate with dose titration to achieve blood levels within the therapeutic range
DRUG	Placebo	Control arm
DRUG	Lithium Carbonate	All participants were started and stabilized on lithium carbonate as a standard treatment for bipolar disorder

Timeline

• Start date: 2006-03-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2005-10-17
• Last updated: 2016-10-17
• Results posted: 2016-10-17

Locations

2 sites across 1 country: United States