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Reinforcing Effects of Cocaine During Phendimetrazine Maintenance

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: Phendimetrazine (Drug); Cocaine (Drug); Placebo (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: University of Kentucky

Overall contact:
William W Stoops, Ph.D., Phone: 859-257-5388, Email: william.stoops@uky.edu


This study will determine the initial efficacy of phendimetrazine as a pharmacotherapy for cocaine dependence. A rigorous, inpatient human laboratory study will be conducted in which the subjective, physiological and reinforcing effects of cocaine are evaluated during maintenance on placebo and phendimetrazine.

Clinical Details

Official title: Behavioral Effects of Drugs (Inpatient): 31 (Cocaine and Phendimetrazine)

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Basic Science

Primary outcome: Reinforcing Effects

Secondary outcome:

Visual Analog Scale of Drug Effects

Likert-type scale of mood

Blood Pressure

Heart rate

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 Department of Behavioral Science, Lexington, Kentucky 40536-0086, 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: August 2015
Last updated: August 11, 2015

Page last updated: August 23, 2015

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