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Sponsors and Collaborators: |
University of Pennsylvania National Institutes of Health (NIH) |
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Information provided by: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT00167245 |
The primary purpose of this study is to test the effectiveness of topiramate for the treatment of combined alcohol and cocaine dependence. Topiramate is approved for the treatment of seizures. It has not been proven to be effective for the treatment of alcohol or cocaine dependence.
Condition | Intervention | Phase |
---|---|---|
Alcoholism Cocaine Dependence |
Drug: Topiramate Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Randomized, Double-Blind, Placebo-Controlled, Pilot Trial of Topiramate for Alcohol and Comorbid Cocaine Dependence |
Estimated Enrollment: | 200 |
Study Start Date: | September 2004 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Group 1: Experimental
topiramate
|
Drug: Topiramate
300mg/day for 13 weeks
|
Group 2: Placebo Comparator |
Drug: placebo
placebo pills
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The purpose of this study is to evaluate the efficacy of 300 mg/day of topiramate for the treatment of 200 treatment-seeking alcohol dependent outpatients with comorbid cocaine dependence in a double-blind, placebo-controlled 14-week trial, with a 6-month follow-up (3months after completing medications).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kyle M Kampman, MD | 215-222-3200 | kampman_k@mail.trc.upenn.edu |
United States, Pennsylvania | |
University of Pennsylvania, Treatment Research Center | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Donna Simpson 215-222-3200 ext 158 Simpson_D@mail.trc.upenn.edu |
Principal Investigator: | Kyle M Kampman, MD | University of Pennsylvania |
Responsible Party: | University of Pennsylvania ( Kyle Kampman, M.D. ) |
Study ID Numbers: | 801385 |
Study First Received: | September 9, 2005 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00167245 |
Health Authority: | United States: Food and Drug Administration |
Topiramate alcoholism cocaine dependence |
Cocaine-Related Disorders Dopamine Mental Disorders Alcoholism Substance-Related Disorders |
Topiramate Disorders of Environmental Origin Alcohol-Related Disorders Cocaine Ethanol |
Dopamine Uptake Inhibitors Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Cardiovascular Agents Protective Agents Neuroprotective Agents |
Pharmacologic Actions Anesthetics, Local Anti-Obesity Agents Sensory System Agents Therapeutic Uses Vasoconstrictor Agents Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |