Zonisamide vs. Placebo in the Treatment of Alcohol Dependence

Completed · Phase 4 · Has a placebo group

Conditions studied: Alcoholism, Alcohol Abuse, Alcohol Dependence

In brief

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

Key facts

Study ID

NCT00595556

Run by

UConn Health

People needed

40

Starts

2006-07-01

Expected to finish

2009-05-01

Last updated by the study team

2010-10-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Connecticut Health Center — Farmington, Connecticut, United States

Full record on ClinicalTrials.gov

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