Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
180 participants
INTERVENTIONAL
2007-03-31
2013-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Topiramate
Topiramate + Cognitive Behavioral Therapy
Topiramate + Cognitive Behavioral Therapy
Topiramate up to 300 mg per day
Placebo
Placebo + Cognitive Behavioral Therapy
Placebo + Cognitive Behavioral Therapy
Placebo twice a day
Interventions
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Topiramate + Cognitive Behavioral Therapy
Topiramate up to 300 mg per day
Placebo + Cognitive Behavioral Therapy
Placebo twice a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must meet at least three of the seven DSM IV diagnostic criteria for alcohol and cocaine dependence.
* Express a desire for treatment.
* Literacy in English and ability to read, understand, and complete the ratings scales and questionnaires accurately, follow instructions, and make use of the behavioral treatments are required.
* Prospective subjects must report cocaine use of at least once per month and alcohol consumption of ≥21 drinks/week and ≥14 drinks/week for men and women respectively, during the past 30 days
* At least one positive urine drug screen for cocaine at screen or baseline prior to randomization.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Bankole Johnson
OTHER
Responsible Party
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Bankole Johnson
Chair of Psychiatry and Neurobehavioral Sciences
Principal Investigators
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Bankole Johnson, DSc, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Locations
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University of Virginia Center for Addiction Research and Education
Charlottesville, Virginia, United States
University of Virginia Center for Addiction Research and Education
Richmond, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DPMCDA
Identifier Type: OTHER
Identifier Source: secondary_id
11620
Identifier Type: -
Identifier Source: org_study_id
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