Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
EARLY_PHASE1
11 participants
INTERVENTIONAL
2014-09-30
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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Placebo
Subjects will be maintained on oral placebo. 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 phendimetrazine.
Placebo
The pharmacodynamic effects of placebo will be determined during maintenance on placebo and phendimetrazine.
Phendimetrazine Dose 1
Subjects will be maintained on the low phendimetrazine dose. Cocaine will be administered acutely during low dose phendimetrazine maintenance.
Placebo will be administered acutely during low dose phendimetrazine maintenance.
Cocaine
The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and phendimetrazine.
Placebo
The pharmacodynamic effects of placebo will be determined during maintenance on placebo and phendimetrazine.
Phendimetrazine Dose 2
Subjects will be maintained on the intermediate phendimetrazine dose. Cocaine will be administered acutely during intermediate dose phendimetrazine maintenance.
Placebo will be administered acutely during intermediate dose phendimetrazine maintenance.
Cocaine
The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and phendimetrazine.
Placebo
The pharmacodynamic effects of placebo will be determined during maintenance on placebo and phendimetrazine.
Phendimetrazine Dose 3
Subjects will be maintained on the high phendimetrazine dose. Cocaine will be administered acutely during high dose phendimetrazine maintenance.
Placebo will be administered acutely during high dose phendimetrazine maintenance.
Cocaine
The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and phendimetrazine.
Placebo
The pharmacodynamic effects of placebo will be determined during maintenance on placebo and phendimetrazine.
Interventions
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Cocaine
The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and phendimetrazine.
Placebo
The pharmacodynamic effects of placebo will be determined during maintenance on placebo and phendimetrazine.
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 or phendimetrazine
18 Years
55 Years
ALL
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
William Stoops
OTHER
Responsible Party
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William Stoops
Associate Professor
Principal Investigators
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William W Stoops, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Kentucky
Locations
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University of Kentucky Laboratory of Human Behavioral Pharmacology
Lexington, Kentucky, United States
Countries
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Other Identifiers
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BED (IN) 29
Identifier Type: -
Identifier Source: org_study_id