NCT02522325

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
7 months until next milestone

Results Posted

Study results publicly available

July 2, 2019

Completed
Last Updated

July 2, 2019

Status Verified

June 1, 2019

Enrollment Period

3.3 years

First QC Date

August 10, 2015

Results QC Date

April 29, 2019

Last Update Submit

June 10, 2019

Conditions

Cocaine Use Disorder

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Subjects will be maintained on oral placebo, administered twice daily for approximately two weeks. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.

Drug: CocaineDrug: Placebo

Phendimetrazine

EXPERIMENTAL

Subjects will be maintained on oral phendimetrazine (up to 210 mg/day) administered twice daily for approximately two weeks. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.

Drug: PhendimetrazineDrug: Cocaine

Interventions

PhendimetrazineDRUG

Phendimetrazine will be administered in divided doses twice daily.

Also known as: Bontril
Phendimetrazine
CocaineDRUG

Intranasal cocaine will be administered during experimental sessions.

PhendimetrazinePlacebo
PlaceboDRUG

Placebo capsules will contain only cornstarch.

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Recent cocaine use

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky Department of Behavioral Science

Lexington, Kentucky, 40536-0086, United States

Location

MeSH Terms

Interventions

phendimetrazineCocaine

Intervention Hierarchy (Ancestors)

TropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Results Point of Contact

Title
William W. Stoops
Organization
University of Kentucky
william.stoops@uky.edu
859-257-5388

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 10, 2015

First Posted

August 13, 2015

Study Start

August 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

July 2, 2019

Results First Posted

July 2, 2019

Record last verified: 2019-06

Locations

US(1)