Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2025-12-24 @ 11:20 PM
NCT ID:
NCT00595556
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00595556
Study Brief:
Protocol Section:
NCT00595556