Drug Treatment for Alcoholics With Bipolar Disorder

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.

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.