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| Sponsor: | University of Pennsylvania |
|---|---|
| Collaborator: |
National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
| Information provided by: | University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00167245 |
Purpose
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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
topiramate
|
Drug: Topiramate
300mg/day for 13 weeks
Other Name: topamax
|
| Placebo Comparator: Group 2 |
Drug: placebo
placebo pills
|
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 (3 months after completing medications).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Pennsylvania | |
| University of Pennsylvania, Treatment Research Center | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: | Kyle M Kampman, MD | University of Pennsylvania |
More Information
| Responsible Party: | Kyle Kampman, M.D., University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00167245 History of Changes |
| Other Study ID Numbers: | 801385, R01AA014657 |
| Study First Received: | September 9, 2005 |
| Last Updated: | August 3, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Topiramate alcoholism cocaine dependence |
|
Alcoholism Cocaine-Related Disorders Alcohol-Related Disorders Substance-Related Disorders Mental Disorders Cocaine Topiramate Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Anesthetics, Local Anesthetics Central Nervous System Depressants Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants Neuroprotective Agents Protective Agents Anti-Obesity Agents |