Zonisamide vs. Placebo in the Treatment of Alcohol Dependence

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00595556
• Date of registration: 06/01/2008
• Primary sponsor: University of Connecticut Health Center
• Public title: Zonisamide vs. Placebo in the Treatment of Alcohol Dependence
• Scientific title: Zonisamide vs. Placebo in the Treatment of Alcohol Dependence
• Date of first enrolment: July 2006
• Target sample size: 40
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00595556
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Albert J. Arias, MD
• Affiliation: University of Connecticut Health Center

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Alcohol Abuse

Alcohol Dependence

Alcoholism

Intervention(s)

Drug: Placebo

Drug: zonisamide

Primary Outcome(s)

Change in Number of Heavy Drinking Days (i.e., 5 or More Drinks Per Day for Men, and 4 or More Per Day for Women)Per Week, by Week [Time Frame: baseline to the end of 12 weeks in treatment]

Weekly Rate of Change in Abstinent Days [Time Frame: baseline to the end of 12 weeks in treatment]

Secondary Outcome(s)

Change in Gamma-glutamyl Transferase (GGT) Concentration [Time Frame: 12 weeks (from initiation to end of treatment)]

Change in Number of Drinks Per Week by Week [Time Frame: baseline to the end of 12 weeks in treatment]

Change in the Urge to Drink Alcohol as Measured by the Alcohol Urge Questionnaire (AUQ) [Time Frame: baseline to the end of 12 weeks in treatment]

Secondary ID(s)

06-113-1

M01RR006192

P50 AA03510

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Center for Research Resources (NCRR)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)