Valproate Efficacy in Cocaine-Bipolar Comorbidity

Bipolar Disorder Clinical Trial

Official title:

Valproate Efficacy in Cocaine-Bipolar Comorbidity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00240110
• Other study ID #: 20070289
• Secondary ID: 5R01DA019992R01D
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 13, 2005
• Last updated: November 19, 2014
• Start date: March 2006
• Est. completion date: March 2014

Study information

• Verified date: November 2014
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Cocaine Dependence

Intervention

Drug:
• Valproate vs. Placebo
Valproate with dose titration to achieve blood levels within the therapeutic range wil be compared to placebo

Locations

Country	Name	City	State
United States	University of Miami Miller School of Medicine	Miami	Florida
United States	University of Miami Miller School of Medicine, Department of Psychiatry	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	This will be operationalized as an increase in the weekly mean proportion of self-report cocaine-abstinent (non-use) days confirmed by urine screen		During the double-blind treatment phase	No
Secondary	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		During the double-blind treatment phase	No