Phase 2
N=26
Valproate Efficacy in Cocaine-Bipolar Comorbidity
Bipolar Disorder · Cocaine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT00240110 ↗Enrolled (actual)
26
Serious AEs
3.9%
Results posted
Oct 2016
Primary outcome: Primary: Change From Baseline in Percentage of Cocaine-abstinent Days — 16.4; 14.5 percentage of days cocaine abstinent
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Valproate (Drug); Placebo (Drug); Lithium Carbonate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Percentage of Cocaine-abstinent Days |
16.4; 14.5 | — |
| SECONDARY Change From Baseline in Percentage of Money Spent on Cocaine |
-43.6; -34.9 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00240110). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.