Status:
COMPLETED
Phendimetrazine and Cocaine
Lead Sponsor:
William Stoops
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cocaine Use Disorder
Eligibility:
All Genders
18-55 years
Phase:
EARLY_PHASE1
Brief Summary
This study will determine the safety and tolerability of phendimetrazine (Bontril®) as a pharmacotherapy for cocaine use disorder. A rigorous, inpatient human laboratory study will be conducted in whi...
Eligibility Criteria
Inclusion
- Recent cocaine use
Exclusion
- Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT02233647
Start Date
September 1 2014
End Date
December 1 2015
Last Update
September 27 2017
Active Locations (1)
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1
University of Kentucky Laboratory of Human Behavioral Pharmacology
Lexington, Kentucky, United States, 40507