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
EARLY_PHASE1
9 participants
INTERVENTIONAL
2018-06-01
2019-05-31
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 methylphenidate 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 duloxetine.
Placebo oral capsule
The pharmacodynamic effects of placebo will be determined during maintenance on placebo and duloxetine.
Methylphenidate
The pharmacodynamic effects of methylphenidate maintenance will be determined during maintenance on placebo and duloxetine.
Duloxetine
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Cocaine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Cocaine
The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and duloxetine.
Placebo oral capsule
The pharmacodynamic effects of placebo will be determined during maintenance on placebo and duloxetine.
Methylphenidate
The pharmacodynamic effects of methylphenidate maintenance will be determined during maintenance on placebo and duloxetine.
Interventions
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Cocaine
The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and duloxetine.
Placebo oral capsule
The pharmacodynamic effects of placebo will be determined during maintenance on placebo and duloxetine.
Methylphenidate
The pharmacodynamic effects of methylphenidate maintenance will be determined during maintenance on placebo and duloxetine.
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, methylphenidate or duloxetine
18 Years
55 Years
ALL
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Craig Rush
OTHER
Responsible Party
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Craig Rush
Professor
Principal Investigators
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Craig R Rush, PhD
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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43500
Identifier Type: -
Identifier Source: org_study_id
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