Intervention: Lamotrigine
Trial phase: Phase 4
ATC code: N03AX09
SMILES: Nc1nnc(-c2cccc(Cl)c2Cl)c(N)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: Add-on lamotrigine plus pre-existing mood stabilizing medication regimen. Active fixed-dose drug titration from 25-200 mg/day over first six weeks, 200 mg/day fixed-dose maintenance for second six weeks

Lamotrigine: Six week titration from 25 mg/day to 200 mg/day, then 200 mg/day maintenance for additional six weeks
Eligibility criteria:
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