Valproate Efficacy in Cocaine-Bipolar Comorbidity
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Bipolar Disorder, Cocaine Dependence
In brief
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.
Key facts
- Study ID
- NCT00240110
- Run by
- University of Miami
- People needed
- 152
- Starts
- 2006-03-01
- Expected to finish
- 2014-03-01
- Last updated by the study team
- 2016-10-17
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Meet DSM-IV criteria for cocaine dependence and a concurrent bipolar disorder
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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