Valproate Efficacy in Cocaine-Bipolar Comorbidity

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.

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.