Conditions: Bipolar Disorder Cocaine Dependence
Keywords: Bipolar Cocaine Comorbidity
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 152
Healthy volunteers: yes

Brief 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.

Arms:
arm 1: Lithium carbonate started and stabilized then participants randomized to placebo arm 2: Lithium carbonate started and stabilized then participants randomized to Valproate

Interventions: intervention 1: Valproate intervention 2: Placebo intervention 3: Lithium Carbonate
Intervention descriptions: intervention 1: Valproate with dose titration to achieve blood levels within the therapeutic range intervention 2: Control arm intervention 3: All participants were started and stabilized on lithium carbonate as a standard treatment for bipolar disorder

Protocol document: