Valproate Efficacy in Cocaine-Bipolar Comorbidity

NCT ID: NCT00240110

Last Updated: 2016-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2014-03-31

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.

Conditions

Bipolar Disorder; Cocaine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lithium carbonate add on Placebo

Lithium carbonate started and stabilized then participants randomized to placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Control arm

Lithium Carbonate

Intervention Type: DRUG

All participants were started and stabilized on lithium carbonate as a standard treatment for bipolar disorder

Lithium carbonate add on Valproate

Lithium carbonate started and stabilized then participants randomized to Valproate

Group Type: EXPERIMENTAL

Valproate

Intervention Type: DRUG

Valproate with dose titration to achieve blood levels within the therapeutic range

Lithium Carbonate

Intervention Type: DRUG

All participants were started and stabilized on lithium carbonate as a standard treatment for bipolar disorder

Interventions

Valproate

Valproate with dose titration to achieve blood levels within the therapeutic range

Intervention Type: DRUG

Placebo

Control arm

Intervention Type: DRUG

Lithium Carbonate

All participants were started and stabilized on lithium carbonate as a standard treatment for bipolar disorder

Intervention Type: DRUG

Other Intervention Names

Divalproex sodium; Placebo control; Standard treatment

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Ihsan Salloum

Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ihsan M Salloum, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami Miller School of Medicine, Department of Psychiatry

Miami, Florida, United States

University of Miami Miller School of Medicine

Miami, Florida, United States

Countries

United States

References

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. doi: 10.1016/j.addbeh.2006.05.007. Epub 2006 Jun 30.

Reference Type: BACKGROUND

PMID: 16814474 (View on PubMed)

Other Identifiers

R01DA019992

Identifier Type: NIH

Identifier Source: secondary_id

View Link

05080018

Identifier Type: OTHER

Identifier Source: secondary_id

DPMCDA

Identifier Type: OTHER

Identifier Source: secondary_id

20070289

Identifier Type: -

Identifier Source: org_study_id