Clinical trial NCT01566370 (phase 2, status: terminated)
Conditions: alcohol use disorders, bipolar disorder
ICD codes: F10.94, F10.980, F10.982, F10.988, F10.99, F10.959, F10.96, F31.81, F31.89, F31.9, F25.0, F31.0, F31.31, F31.32
Drugs: zonisamide, placebo
SMILES: NS(=O)(=O)CC1=NOC2=CC=CC=C12, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Reason stopped: 
    recruitment infeasible
  
Eligibility criteria:

        Inclusion Criteria:

          -  Female/male aged 18-65 years

          -  Ability to provide informed consent to participate

          -  Presence of Axis I diagnosis of BD (either type I, Type II, or NOS), in manic,
             hypomanic, depressive, mixed, or euthymic states plus presence of Axis I diagnosis of
             a current AUD and/or "at risk" regular heavy drinking (must average >2 heavy drinking
             days per week) with the goal of reducing or stopping drinking

          -  treatment with a standard mood stabilizer medication and or other medications with
             known psychotropic effects on mood state but not alcohol use; Lithium, and/or atypical
             antipsychotic medications will be the preferred medications,

          -  Subjects not on any primary acceptable mood stabilizer as described above must be
             willing to begin treatment with Lithium in open label fashion,

          -  English speaking, Able to read at the eighth grade or higher level and show no
             evidence of significant cognitive impairment;

          -  Women of child-bearing potential (i.e., no hysterectomy, bilateral oophorectomy, or
             tubal ligation or <2 years postmenopausal), must be non-lactating, practicing a
             reliable method of birth control, and have a negative serum pregnancy test prior to
             initiation of treatment;

          -  Must continue to have at least 2 heavy drinking days per week (averaged per month,
             with heavy drinking defined as having >4 standard drinks per day for males, and >3
             standard drinks per day for females) up to the screening appointment

        Exclusion Criteria:

          -  Presence of another major Axis I disorder such as Schizophrenia or Schizoaffective
             disorder, Delusional disorder, or other severe psychiatric disorder. A history of
             suicidal or violent behavior which, in the opinion of the study physician, puts the
             patient at significant risk of suicide or homicide during the study.

          -  Past history of drug abuse or dependence will be allowed, but active drug dependence
             (with the exception of nicotine dependence) in the last 30 days will be disqualifying.

          -  Serious neurological, or endocrine disorder,

          -  Evidence of potentially serious or as yet undiagnosed medical problems,

          -  Neurocognitive cognitive or language limitations, or other incapacity with providing
             informed consent;

          -  Known adverse reaction to zonisamide, sulfa-drug allergy, penicillin allergy, other
             severe adverse drug reaction or allergy, or any serious systemic autoimmune illness,

          -  Patients currently undergoing ECT treatment.

          -  Also patients with a history of seizures (other than febrile seizures), renal calculi,
             or currently taking medications that could either significantly increase the risk of
             seizures (e.g., tricyclic antidepressant agents, Bupropion, clozaril), or that could
             potentially theoretically significantly influence drinking behavior such as
             benzodiazepines, stimulants, opioid painkillers, sedative-hypnotics, etc.).

          -  Subjects on the following anticonvulsant medications will also be excluded as they may
             increase the risk of similar side-effects (similar to zonisamide) such as rash,
             cognitive impairment, or potentially could confound the study of drinking behavior;
             topiramate, tiagabine, oxcarbazepine, carbamezapine, valproic acid, lamotrigine

          -  Patients who, on clinical examination by a physician, are deemed to be too severely
             alcohol dependent to permit them to participate in an outpatient level of care
             medication trial. We have, over the years, developed methods for reliably and safely
             assessing patients for alcohol treatment and dual diagnosis studies.