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Topiramate-Phentermine Combinations for Cocaine Dependence

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); Phentermine (Drug); Topiramate (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: University of Kentucky

Official(s) and/or principal investigator(s):
Craig R Rush, Ph.D., Principal Investigator, Affiliation: University of Kentucky

Overall contact:
Craig R Rush, Ph.D., Phone: 859-257-5388, Email: crush2@email.uky.edu


This study will determine the influence of topiramate (Topamax®) and phentermine (Adipex®), alone and in combination, on the reinforcing, subjective and physiological effects of cocaine.

Clinical Details

Official title: Topiramate-Phentermine Combinations for Cocaine Dependence

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

Primary outcome: Reinforcing Effects

Secondary outcome:

Subjective effects

Physiological Effects

Side effects


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


Inclusion Criteria:

- Recent cocaine use by the intranasal or intravenous route

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, topiramate or phentermine

Locations and Contacts

Craig R Rush, Ph.D., Phone: 859-257-5388, Email: crush2@email.uky.edu

University of Kentucky Medical Center, Lexington, Kentucky 40536, United States; Recruiting
William W Stoops, Ph.D., Phone: 859-257-5388, Email: william.stoops@uky.edu
Craig R Rush, 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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