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Valproate Efficacy in Cocaine-Bipolar Comorbidity

Information source: University of Miami
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bipolar Disorder; Cocaine Dependence

Intervention: Valproate vs. Placebo (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: University of Miami

Official(s) and/or principal investigator(s):
Ihsan M Salloum, MD, MPH, Principal Investigator, Affiliation: University of Miami


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.

Clinical Details

Official title: Valproate Efficacy in Cocaine-Bipolar Comorbidity

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: This will be operationalized as an increase in the weekly mean proportion of self-report cocaine-abstinent (non-use) days confirmed by urine screen

Secondary outcome: Percentage of cocaine-abstinent days, proportion of participants with total abstinence, time to relapse to cocaine use, severity of cocaine use, cocaine craving scales, severity of HIV risk behavior

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.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


Inclusion Criteria:

- Meet DSM-IV criteria for cocaine dependence and a concurrent bipolar disorder

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.

Locations and Contacts

University of Miami Miller School of Medicine, Miami, Florida 33136, United States

University of Miami Miller School of Medicine, Department of Psychiatry, Miami, Florida 33136, United States

Additional Information

Related publications:

Salloum IM, Douaihy A, Cornelius JR, Kirisci L, Kelly TM, Hayes J. Divalproex utility in bipolar disorder with co-occurring cocaine dependence: a pilot study. Addict Behav. 2007 Feb;32(2):410-5. Epub 2006 Jun 30.

Starting date: March 2006
Last updated: November 19, 2014

Page last updated: August 20, 2015

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