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Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) University of Virginia |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00448825 |
The purpose of this study is to evaluate the effects of Topiramate and Cognitive Behavioral Therapy for the treatment of alcohol and cocaine dependence.
Condition | Intervention | Phase |
---|---|---|
Alcohol Dependence Cocaine Dependence |
Drug: Topiramate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | Novel Pharmacotherapy for Dual Dependence |
Estimated Enrollment: | 180 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | March 2013 |
Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Topiramate: Experimental |
Drug: Topiramate
Topiramate up to 300 mg per day
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Placebo: Placebo Comparator |
Drug: Topiramate
Topiramate up to 300 mg per day
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Our objective is to understand the basic mechanisms that underpin substance dependence, and to develop efficacious treatments for individuals with comorbid cocaine and alcohol dependence.
Participants in this study will be randomly assigned to receive either 300 mg per day of topiramate or placebo.
In addition, participants will receive weekly cognitive behavioral therapy for 12 weeks.Follow-up visits will occur at 2 weeks and 1,2,, and 3 months following completion of treatment.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mindy Borszich, BA | 1-888-882-2345 | uvacare@virginia.edu |
United States, Virginia | |
UVA CARE | Recruiting |
Charlottesville, Virginia, United States, 22911 | |
Principal Investigator: Bankole Johnson, DSc,MD,PhD | |
Sub-Investigator: Nassima Ait-Daoud, MD | |
UVA CARE Richmond | Recruiting |
Richmond, Virginia, United States, 23294 | |
Principal Investigator: Bankole Johnson, DSc,MD,PhD | |
Sub-Investigator: Nassima Ait-Daoud, MD |
Principal Investigator: | Bankole Johnson, DSc, MD, PhD | University of Virginia |
Responsible Party: | University of Virginia ( Bankole Johnson, DSc, M.D., Ph.D. ) |
Study ID Numbers: | 1 R01 DA019804-01A1, R01 DA019804, DPMCDA |
Study First Received: | March 15, 2007 |
Last Updated: | April 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00448825 History of Changes |
Health Authority: | United States: Food and Drug Administration |
alcohol dependence alcoholism cocaine addiction cocaine dependence |
Cocaine-Related Disorders Behavior, Addictive Disorders of Environmental Origin Neuroprotective Agents Anti-Obesity Agents Mental Disorders Alcoholism |
Substance-Related Disorders Topiramate Alcohol-Related Disorders Cocaine Anticonvulsants Ethanol |
Cocaine-Related Disorders Physiological Effects of Drugs Disorders of Environmental Origin Neuroprotective Agents Protective Agents Pharmacologic Actions Anti-Obesity Agents Mental Disorders |
Therapeutic Uses Alcoholism Substance-Related Disorders Topiramate Alcohol-Related Disorders Central Nervous System Agents Anticonvulsants |