Drug Treatment for Alcoholics With Bipolar Disorder

• Status: Completed
• Trial end date: 2003-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to test the effectiveness of sodium valproate (Depacon) in treating individuals with alcohol dependence and comorbid bipolar disorder.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Collaborator: University of Pittsburgh
• Treatments: Valproic Acid

Criteria

Inclusion Criteria:

• Meets the criteria for alcohol dependence with comorbid bipolar disorder.

• Agreement to participate in outpatient treatment.

• Ability to tolerate lithium carbonate and be randomized to receive sodium valproate or placebo.

• Stable living situation.

• Ability to provide informed consent.

Exclusion Criteria:

• Psychiatric conditions including schizophrenia, schizoaffective disorder, any non-bipolar psychotic disorder, unipolar major depression, mental retardation, or signs of impaired cognitive functioning.

• Neurological conditions including epilepsy, history of brain injury, encephalitis, or any organic brain syndrome or focally abnormal electroencephalographic examination.

• Medical conditions including severe cardiac, liver, kidney, endocrine, hematologic, other impairing or unstable medical condition or impending surgery.

• Persistent elevation of liver function enzymes indicating active liver disease.

• Pregnancy or not using an acceptable contraceptive method.

• Inability to read or understand study forms; agree to informed consent.

• Impending incarceration or a mandate to attend treatment by the legal system for an alcohol use disorder.

• The presence of either/or cocaine dependence, opioid dependence, and intravenous drug use.