Drug Treatment for Alcoholics With Bipolar Disorder

Launched by NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM (NIAAA) · Nov 2, 1999

Keywords

ClinConnect Summary

The aim of this study is to test the mood stabilizer, anticonvulsant, sodium valproate in individuals with alcohol dependence and bipolar disorder, in a double-blind, placebo-controlled, and randomized trial of 6 months duration. All subjects are treated with treatment as usual, which include lithium carbonate and individual dual recovery counseling and are randomized to either sodium valproate or placebo.

Gender

ALL

Eligibility 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.