Topiramate-Phentermine Combinations for Cocaine Dependence
NCT ID: NCT02239913
Last Updated: 2019-11-27
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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COMPLETED
PHASE1
38 participants
INTERVENTIONAL
2014-09-30
2019-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
BASIC_SCIENCE
TRIPLE
Study Groups
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Placebo
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and phentermine during placebo maintenance. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Cocaine
The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and topiramate.
Placebo
The pharmacodynamic effects of placebo will be determined during maintenance on placebo and topiramate.
Phentermine
The pharmacodynamic effects of phentermine maintenance will be determined during maintenance on placebo and topiramate.
Topiramate Dose 1
Subjects will be maintained on the low topiramate dose. Subjects will be maintained on placebo and phentermine during maintenance on the low dose of topiramate. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Cocaine
The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and topiramate.
Placebo
The pharmacodynamic effects of placebo will be determined during maintenance on placebo and topiramate.
Phentermine
The pharmacodynamic effects of phentermine maintenance will be determined during maintenance on placebo and topiramate.
Topiramate
The pharmacodynamic effects of chronic topiramate will be determined.
Topiramate Dose 2
Subjects will be maintained on the high topiramate dose. Subjects will be maintained on placebo and phentermine during maintenance on the high dose of topiramate. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Cocaine
The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and topiramate.
Placebo
The pharmacodynamic effects of placebo will be determined during maintenance on placebo and topiramate.
Phentermine
The pharmacodynamic effects of phentermine maintenance will be determined during maintenance on placebo and topiramate.
Topiramate
The pharmacodynamic effects of chronic topiramate will be determined.
Interventions
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Cocaine
The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and topiramate.
Placebo
The pharmacodynamic effects of placebo will be determined during maintenance on placebo and topiramate.
Phentermine
The pharmacodynamic effects of phentermine maintenance will be determined during maintenance on placebo and topiramate.
Topiramate
The pharmacodynamic effects of chronic topiramate will be determined.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Current or past histories of substance abuse or dependence that are deemed by the study physicians to interfere with study completion
* History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation
* Females not currently using effective birth control
* Contraindications to cocaine, topiramate or phentermine
18 Years
55 Years
ALL
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
University of Kentucky
OTHER
Responsible Party
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Craig Rush
Professor
Principal Investigators
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Craig R Rush, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Kentucky
Locations
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University of Kentucky Medical Center
Lexington, Kentucky, United States
Countries
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Other Identifiers
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BED IN 27
Identifier Type: -
Identifier Source: org_study_id
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