Status:
COMPLETED
Valproate Efficacy in Cocaine-Bipolar Comorbidity
Lead Sponsor:
University of Miami
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Bipolar Disorder
Cocaine Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
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 contr...
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 chal...
Eligibility Criteria
Inclusion
- Meet DSM-IV criteria for cocaine dependence and a concurrent bipolar disorder
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT00240110
Start Date
March 1 2006
End Date
March 1 2014
Last Update
October 17 2016
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Miami Miller School of Medicine, Department of Psychiatry
Miami, Florida, United States, 33136
2
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136