Phendimetrazine and Cocaine
Information source: University of Kentucky
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cocaine Use Disorder
Intervention: Cocaine (Drug); Placebo (Drug)
Phase: Phase 0
Status: Recruiting
Sponsored by: University of Kentucky Official(s) and/or principal investigator(s): William W Stoops, Ph.D., Principal Investigator, Affiliation: University of Kentucky
Overall contact: William W Stoops, Ph.D., Phone: 859-257-5388, Email: william.stoops@uky.edu
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 which the subjective and physiological effects of cocaine are evaluated
during maintenance on placebo and phendimetrazine.
Clinical Details
Official title: Safety and Tolerability of Cocaine During Phendimetrazine Maintenance
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Basic Science
Primary outcome: Physiological Effects
Secondary outcome: Subjective EffectsSide Effects
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Recent cocaine use
Exclusion Criteria:
- 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
Locations and Contacts
William W Stoops, Ph.D., Phone: 859-257-5388, Email: william.stoops@uky.edu
University of Kentucky Laboratory of Human Behavioral Pharmacology, Lexington, Kentucky 40507, United States; Recruiting William W Stoops, Ph.D., Phone: 859-257-5388, Email: william.stoops@uky.edu William W Stoops, Ph.D., Principal Investigator
Additional Information
Starting date: September 2014
Last updated: May 11, 2015
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