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| Sponsor: | University of Connecticut Health Center |
|---|---|
| Collaborators: |
National Institute on Alcohol Abuse and Alcoholism (NIAAA) National Center for Research Resources (NCRR) |
| Information provided by: | University of Connecticut Health Center |
| 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 |
| 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 |
| Enrollment: | 40 |
| Study Start Date: | July 2006 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 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
|
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 |
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:
Contacts and Locations| United States, Connecticut | |
| University of Connecticut Health Center | |
| Farmington, Connecticut, United States, 06030 | |
| Principal Investigator: | Albert J. Arias, MD | University of Connecticut Health Center |
More Information
| 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 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00595556 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Zonisamide Pharmacotherapy Alcohol dependence anticonvulsant |
|
Antioxidants Molecular Mechanisms of Pharmacological Action Zonisamide Physiological Effects of Drugs Disorders of Environmental Origin Protective Agents Pharmacologic Actions |
Mental Disorders Therapeutic Uses Alcoholism Substance-Related Disorders Alcohol-Related Disorders Central Nervous System Agents Anticonvulsants |