Methylphenidate-Duloxetine Combinations for Cocaine Dependence
NCT ID: NCT02700711
Last Updated: 2018-06-26
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
13 participants
INTERVENTIONAL
2016-02-29
2018-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
Methylphenidate
The pharmacodynamic effects of methylphenidate maintenance will be determined during maintenance on placebo and duloxetine.
Placebo
The pharmacodynamic effects of placebo will be determined during maintenance on placebo and duloxetine.
Duloxetine
Subjects will be maintained on oral duloxetine. Subjects will be maintained on placebo and methylphenidate during duloxetine maintenance.
Methylphenidate
The pharmacodynamic effects of methylphenidate maintenance will be determined during maintenance on placebo and duloxetine.
Placebo
The pharmacodynamic effects of placebo will be determined during maintenance on placebo and duloxetine.
Duloxetine
The pharmacodynamic effects of duloxetine will be determined during maintenance on placebo and methylphenidate
Interventions
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Methylphenidate
The pharmacodynamic effects of methylphenidate maintenance will be determined during maintenance on placebo and duloxetine.
Placebo
The pharmacodynamic effects of placebo will be determined during maintenance on placebo and duloxetine.
Duloxetine
The pharmacodynamic effects of duloxetine will be determined during maintenance on placebo and methylphenidate
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Seeking treatment for cocaine use
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 or current unstable physical disease (e.g., past myocardial infarction, uncontrolled hypertension, diabetes, head trauma, seizures or CNS tumors) or current or past histories of serious psychiatric disorder or suicidal risk, other than substance abuse or dependence, will be excluded from research participation
* Females not currently using effective birth control
* Contraindications to cocaine, methylphenidate or duloxetine
* Currently using opioids for pain or who are currently maintained on methadone or buprenorphine for opioid use disorder will be excluded from participation
* Body weight less than 50 kg
18 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
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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RCT: 03
Identifier Type: -
Identifier Source: org_study_id
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