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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


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 Effects

Side Effects


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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