Valproate Efficacy in Cocaine-Bipolar Comorbidity

Phase 1

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Schizophrenia, schizoaffective, and any non-bipolar psychotic disorder, unipolar major depression, primary anxiety disorder, mental retardation, and signs of impaired cognitive functioning.
Current DSM-IV criteria for dependence on substances other than cocaine, alcohol, cannabis, nicotine, or caffeine
Neurological conditions including epilepsy, history of brain injury, encephalitis, or any organic brain syndrome or documented focally abnormal EEG
Medical conditions including severe cardiac, liver, kidney, or liver disease.
Pregnancy
Inability or unwillingness to use contraceptive methods
Any medical condition or other reason that in the opinion of the investigator would prevent the subject from completing the protocol.

Arm && Interventions

Group	Intervention	Description
Lithium carbonate add on Placebo	Placebo	Lithium carbonate started and stabilized then participants randomized to placebo
Lithium carbonate add on Placebo	Lithium Carbonate	Lithium carbonate started and stabilized then participants randomized to placebo
Lithium carbonate add on Valproate	Valproate	Lithium carbonate started and stabilized then participants randomized to Valproate
Lithium carbonate add on Valproate	Lithium Carbonate	Lithium carbonate started and stabilized then participants randomized to Valproate

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Percentage of Cocaine-abstinent Days	Week 12	Change from baseline in percentage of self-report cocaine-abstinent (non-use) days (difference in base percent values)

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Percentage of Money Spent on Cocaine	week 12	Change from baseline in percentage of the amount of money spent on cocaine

Locations (2): University of Miami Miller School of Medicine
🇺🇸
Miami, Florida, United States
University of Miami Miller School of Medicine, Department of Psychiatry
🇺🇸
Miami, Florida, United States