Reinforcing Effects of Cocaine During Phendimetrazine Maintenance

Cocaine Use Disorder Clinical Trial

— BED IN 31  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02522325
• Other study ID #: 15-0553
• Secondary ID: R01DA036553
• Status: Completed
• Phase: Phase 1
• Start date: August 2015
• Est. completion date: December 2018

Study information

• Verified date: June 2019
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Cocaine Use Disorder

Intervention

Drug:
• Phendimetrazine
Phendimetrazine will be administered in divided doses twice daily.
• Cocaine
Intranasal cocaine will be administered during experimental sessions.
• Placebo
Placebo capsules will contain only cornstarch.

Locations

Country	Name	City	State
United States	University of Kentucky Department of Behavioral Science	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
William Stoops	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative	The reinforcing effects of cocaine were determined using a modified progressive ratio procedure in which subjects made 10 choices between a portion of each available cocaine dose and money (US$0.25). Reinforcing effects are measured for each cocaine dose during both phendimetrazine and placebo maintenance.	After at least seven days of maintenance placebo or target phendimetrazine dose