Treatment of Alcohol Dependence and Comorbid Bipolar Disorder

Inclusion Criteria:

- Age 18-65

- Meet DSM-IV-TR criteria for current alcohol dependence with active alcohol use in the
past 30 days

- Meet DSM-IV-TR criteria for bipolar I or bipolar II disorder

- Have average alcohol consumption of at least 35 drinks/week for men, 28 drinks/week
for women in the last 4 weeks of active drinking prior to enrollment.

- Able to provide informed consent and function at an intellectual level sufficient to
allow accurate completion of the assessment instruments.

- Must consent to random assignment and be willing to commit to medication treatment and
follow-up assessments.

- Currently under the care of a psychiatrist.

- Must consent to sign a release of information allowing investigators to communicate
with his/her psychiatrist to verify treatment history and facilitate care should
treatment-emergent psychiatric symptoms develop during the trial.

- Currently taking a therapeutic dosage of one or more mood stabilizing medications as
defined by one or more of the following:

- Lithium level of 0.6 - 1.2 mEq/L

- Prescribed daily use of first generation antipsychotic agents including
chlorpromazine, fluphenazine, or haloperidol or their injectible depot
(decanoate) equivalents at a dose adequate to maintain clinical stability as
documented by the subject's outpatient psychiatric provider c) Prescribed daily
use of second generation antipsychotic agents including olanzapine, risperidone,
paliperidone, quetiapine, aripiprazole, or ziprasidone or their injectible depot
equivalent at a dose adequate to maintain clinical stability as documented by the
subject's outpatient psychiatric provider

- Stable psychiatric symptoms as defined by no changes to psychotropic drug regimen for
30 days

- Must agree to identify collateral individuals for contact to facilitate follow-up
appointments

Exclusion Criteria:

- A primary psychiatric diagnosis other than bipolar disorder

- Any uncontrolled neurologic condition (e.g. epilepsy) that could confound the results
of the study

- Any history of Stevens-Johnson syndrome or other severe rash requiring hospitalization

- Any history of head injury with loss of consciousness greater than 30 minutes

- Any history of learning disability, alcoholic dementia, or electroconvulsive therapy
in the past 3 months

- Any uncontrolled medical condition that may adversely affect the conduct of the trial
or jeopardize the safety of the subject

- Plasma levels of liver transaminases (AST, ALT) greater than 3 times the normal range

- Concomitant use of valproic acid

- Concomitant use of carbamazepine, oxcarbazepine, phenytoin, primidone, or
phenobarbital

- Concomitant use of disulfiram, naltrexone, acamprosate, or topiramate

- Concomitant use of benzodiazepines or any other medications not allowed per the
protocol

- Women of childbearing potential who are pregnant, lactating, or refuse adequate forms
of contraception

- Current suicidal or homicidal risk

- Baseline scores of more than 35 on the Montgomery-Asberg Depression Rating Scale or
more than 16 on the Young Mania Rating Scale