Valproate Efficacy in Cocaine-Bipolar Comorbidity

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ClinicalTrials.gov Identifier: NCT00240110

Recruitment Status : Completed

First Posted : October 17, 2005

Results First Posted : October 17, 2016

Last Update Posted : October 17, 2016

Sponsor:

Collaborator:

National Institute on Drug Abuse (NIDA)

Information provided by (Responsible Party):

Ihsan Salloum, University of Miami

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Bipolar Disorder Cocaine Dependence	Drug: Valproate Drug: Placebo Drug: Lithium Carbonate	Phase 1 Phase 2

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:

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.
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.
Assess the effects of medication compliance and mood symptoms as mediators of cocaine use outcome.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	152 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Valproate Efficacy in Cocaine-Bipolar Comorbidity
Study Start Date :	March 2006
Actual Primary Completion Date :	March 2014
Actual Study Completion Date :	March 2014

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Bipolar disorder

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Valproic acid Lithium carbonate Valproate sodium Lithium citrate Divalproex sodium

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Lithium carbonate add on Placebo Lithium carbonate started and stabilized then participants randomized to placebo	Drug: Placebo Control arm Other Name: Placebo control Drug: Lithium Carbonate All participants were started and stabilized on lithium carbonate as a standard treatment for bipolar disorder Other Name: Standard treatment
Experimental: Lithium carbonate add on Valproate Lithium carbonate started and stabilized then participants randomized to Valproate	Drug: Valproate Valproate with dose titration to achieve blood levels within the therapeutic range Other Name: Divalproex sodium Drug: Lithium Carbonate All participants were started and stabilized on lithium carbonate as a standard treatment for bipolar disorder Other Name: Standard treatment

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

Change From Baseline in Percentage of Money Spent on Cocaine [ Time Frame: week 12 ]
Change from baseline in percentage of the amount of money spent on cocaine

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00240110

Locations

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

Sponsors and Collaborators

University of Miami

National Institute on Drug Abuse (NIDA)

Investigators

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Principal Investigator:	Ihsan M Salloum, MD, MPH	University of Miami

More Information

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.

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Responsible Party:	Ihsan Salloum, Professor of Psychiatry, University of Miami
ClinicalTrials.gov Identifier:	NCT00240110
Other Study ID Numbers:	20070289 R01DA019992 ( U.S. NIH Grant/Contract ) 05080018 ( Other Identifier: NIDA ) DPMCDA ( Other Identifier: NIDA )
First Posted:	October 17, 2005 Key Record Dates
Results First Posted:	October 17, 2016
Last Update Posted:	October 17, 2016
Last Verified:	August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Ihsan Salloum, University of Miami:


Bipolar Cocaine Comorbidity

Additional relevant MeSH terms:

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Cocaine-Related Disorders Bipolar Disorder Bipolar and Related Disorders Mental Disorders Substance-Related Disorders Chemically-Induced Disorders Valproic Acid Lithium Carbonate Antidepressive Agents Psychotropic Drugs	Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Anticonvulsants GABA Agents Neurotransmitter Agents

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