Clinical trial NCT00240110: Valproate Efficacy in Cocaine-Bipolar Comorbidity
Official title: Valproate Efficacy in Cocaine-Bipolar Comorbidity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Bipolar Disorder
Cocaine Dependence
Keywords: Bipolar
Cocaine
Comorbidity
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2005-10-17
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change From Baseline in Percentage of Cocaine-abstinent Days
timeFrame: Week 12
Secondary outcomes:
measure: Change From Baseline in Percentage of Money Spent on Cocaine
timeFrame: week 12
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Miller School of Medicine, Department of Psychiatry
state: Florida
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
Study officials:
affiliation: University of Miami
name: Ihsan M Salloum, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.