Zonisamide vs. Placebo in the Treatment of Alcohol Dependence
Condition: Alcoholism; Alcohol Abuse; Alcohol Dependence
MeSH terms: Alcoholism
Intervention: zonisamide; Placebo
Intervention description: flexible dosages of 100-500mg/day; Placebo
Intervention MeSH terms: Zonisamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Zonisamide; Pharmacotherapy; Alcohol dependence; anticonvulsant

Summary:

      This is a pilot study designed to examine the potential efficacy and tolerability of
      zonisamide compared to placebo for the treatment of alcohol dependence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 18 to 65 years, inclusive

          -  current Diagnostic & Statistical Manual of Mental Disorders 4th ed (DSM-IV) alcohol
             dependence (within the past month)

          -  have 2 heavy drinking days per week during the period between screening and baseline
             (defined as >4 standard drinks per day for males, and >3 standard drinks per day for
             females)

          -  able to read at the eighth grade or higher level and show no evidence of significant
             cognitive impairment

          -  if a woman of child-bearing potential (i.e., who has not had a hysterectomy, bilateral
             oophorectomy, tubal ligation or who is less than two years postmenopausal), must be
             non-lactating, practicing a reliable method of birth control including barrier method;
             and have a negative serum pregnancy test prior to initiation of treatment

          -  be willing to provide signed, informed consent to participate in the study

        Exclusion Criteria:

          -  have a current, clinically significant physical disease or abnormality (i.e.,
             neurologic, renal, rheumatologic, gastrointestinal, hematologic, pulmonary, endocrine,
             cardiovascular, hepatic, or autoimmune disease that, in the context of the study would
             represent a risk to the subject, or significant laboratory abnormalities such as
             hepatic aminotransferase levels greater than 300% of the uper limit of normal or
             direct bilirubin levels 150% of the upper limit of normal) on the basis of medical
             history, physician examination, or routine laboratory evaluation. Serum creatinine
             level of > 1.2 mg/dl will also be exclusionary. Other specific exclusionary disorders
             include:

               -  patients with a history of renal calculi

               -  patients with a history of hypersensitivity to zonisamide or any sulfonamide,
                  Stevens-Johnson Syndrome, penicillin allergy, or history of any severe drug
                  allergic reaction

               -  patients with a significant history of systemic autoimmune disease such as lupus
                  erythematosis, fibromyalgia, or rheumatoid arthritis

               -  patients with a current blood dyscrasia or a history of such, with the exception
                  of a remote history of iron deficient anemia

          -  have a serious psychiatric illness (i.e., schizophrenia, bipolar disorder, severe or
             psychotic major depression, panic disorder, or substantial suicide or violence risk)
             on the basis of history or psychiatric examination

          -  current dependence on opioids or benzodiazepines or other sedatives will also be
             exclusionary

          -  are considered by investigators to be clinically inappropriate for study participation

          -  because individuals with a history of seizure disorder could potentially be at
             increased risk of experiencing a seizure due to their drinking, such individuals will
             also be excluded

          -  have participated in another pharmacotherapy study in the past thirty days