drugset / Trial / NCT00240110
Valproate Efficacy in Cocaine-Bipolar Comorbidity
Phase 1/2
Completed
152 enrolled
University of Miami
National Institute on Drug Abuse (NIDA) · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2006-03
- Primary completion
- 2014-03
- Completion
- 2014-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Valproate | Small molecule | — | — |
| Background | Lithium Carbonate | Unknown | — | — |