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Sponsors and Collaborators: |
University of Connecticut Health Center National Institute on Alcohol Abuse and Alcoholism (NIAAA) National Center for Research Resources (NCRR) |
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Information provided by: | University of Connecticut |
ClinicalTrials.gov Identifier: | NCT00595556 |
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 |
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Alcoholism Alcohol Abuse Alcohol Dependence |
Drug: zonisamide Drug: Placebo |
Phase IV |
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 |
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 |
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A: Experimental
Zonisamide
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Drug: zonisamide
flexible dosages of 100-500mg/day
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B: Placebo Comparator
placebo
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Drug: Placebo
Placebo
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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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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:
Contact: Kristen A Tremblay, MPH | 860-679-4755 | tremblay@psychiatry.uchc.edu |
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 |
Principal Investigator: | Albert J. Arias, MD | University of Connecticut Health Center |
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 |
Zonisamide Pharmacotherapy Alcohol dependence anticonvulsant |
Mental Disorders Zonisamide Alcoholism Substance-Related Disorders |
Disorders of Environmental Origin Alcohol-Related Disorders Ethanol |
Antioxidants Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Central Nervous System Agents Protective Agents Anticonvulsants Pharmacologic Actions |