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Zonisamide vs. Placebo in the Treatment of Alcohol Dependence
This study is currently recruiting participants.
Verified by University of Connecticut, November 2008
Sponsors and Collaborators: University of Connecticut Health Center
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Center for Research Resources (NCRR)
Information provided by: University of Connecticut
ClinicalTrials.gov Identifier: NCT00595556
  Purpose

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


Condition Intervention Phase
Alcoholism
Alcohol Abuse
Alcohol Dependence
Drug: zonisamide
Drug: Placebo
Phase IV

MedlinePlus related topics: Alcoholism
Drug Information available for: Zonisamide Ethanol
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Zonisamide vs. Placebo in the Treatment of Alcohol Dependence

Further study details as provided by University of Connecticut:

Primary Outcome Measures:
  • percentage of days abstinent [ Time Frame: 12 weeks (adjusted for days in treatment) ] [ Designated as safety issue: No ]
  • percentage of heavy drinking days (i.e., 5 or more drinks per day for men, and 4 or more per day for women) [ Time Frame: 12 weeks (adjusted for days in treatment) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in gamma-glutamyl transferase (GGT) concentration [ Time Frame: 12 weeks (from initiation to end of treatment) ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2006
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
Zonisamide
Drug: zonisamide
flexible dosages of 100-500mg/day
B: Placebo Comparator
placebo
Drug: Placebo
Placebo

Detailed Description:

Zonisamide is an antiepileptic medication which has similar clinical and pharmacologic effects to topiramate, a medication that has demonstrated efficacy in a randomized clinical trial for treatment of alcoholism. Because zonisamide is potentially better tolerated and easier to titrate in the outpatient setting than topiramate, it may offer important clinical advantages in the treatment of alcoholism.

This is a small 12-week placebo-controlled pilot study examining tolerability and potential efficacy in anticipation of a larger, placebo-controlled trial of zonisamide for treatment of alcohol dependence. It is a randomized, double-blind trial of zonisamide vs. placebo at flexible dosages of 100-500mg/day in alcoholics receiving ambulatory psychosocial treatment. Participants will take part in six individual Cognitive-Behavioral based therapy sessions, which are focused on learning coping skills. Participants must endorse a goal of either cutting down their drinking to non-hazardous levels, or abstinence.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00595556

Contacts
Contact: Kristen A Tremblay, MPH 860-679-4755 tremblay@psychiatry.uchc.edu

Locations
United States, Connecticut
University of Connecticut Health Center Recruiting
Farmington, Connecticut, United States, 06030
Contact: Kristen A. Tremblay, MPH     860-679-4755     tremblay@psychiatry.uchc.edu    
Principal Investigator: Albert J. Arias, MD            
Sub-Investigator: Henry R. Kranzler, MD            
Sub-Investigator: Jonathan M. Covault, MD, PhD            
Sub-Investigator: Cheryl Oncken, MD, MPH            
Sub-Investigator: Carolyn Drazinic, MD, PhD            
Sub-Investigator: Richard Feinn, PhD            
Sponsors and Collaborators
University of Connecticut Health Center
Investigators
Principal Investigator: Albert J. Arias, MD University of Connecticut Health Center
  More Information

University of Connecticut Health Center, Dept. of Psychiatry Research Studies  This link exits the ClinicalTrials.gov site

Responsible Party: University of Connecticut Health Center ( Albert J. Arias, MD )
Study ID Numbers: 06-113-1, P60AA03510-7C
Study First Received: January 6, 2008
Last Updated: November 6, 2008
ClinicalTrials.gov Identifier: NCT00595556  
Health Authority: United States: Institutional Review Board

Keywords provided by University of Connecticut:
Zonisamide
Pharmacotherapy
Alcohol dependence
anticonvulsant

Study placed in the following topic categories:
Mental Disorders
Zonisamide
Alcoholism
Substance-Related Disorders
Disorders of Environmental Origin
Alcohol-Related Disorders
Ethanol

Additional relevant MeSH terms:
Antioxidants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Agents
Protective Agents
Anticonvulsants
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009