Zonisamide vs. Placebo in the Treatment of Alcohol Dependence

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UConn Health
• Collaborators: National Center for Research Resources (NCRR); National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Ethanol; Zonisamide

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