Trial Outcomes & Findings for Reinforcing Effects of Cocaine During Phendimetrazine Maintenance (NCT NCT02522325)

Last Updated: 2019-07-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

30 participants

Primary outcome timeframe

After at least seven days of maintenance placebo or target phendimetrazine dose

Results posted on

2019-07-02

Participant Flow

Thirty subjects were enrolled, but one was removed from the study due to an adverse event, leading to 29 completers.

Participant milestones

Participant milestones
Measure	Placebo First, Then Phendimetrazine Subjects were maintained on placebo for approximately 2 weeks, then they were crossed over to 210 mg phendimetrazine daily for approximately 2 weeks.	Phendimetrazine First, Then Placebo Subjects were maintained on 210 mg phendimetrazine for approximately 2 weeks, then they were crossed over to placebo daily for approximately 2 weeks.
Overall Study STARTED	15	15
Overall Study COMPLETED	15	14
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo First, Then Phendimetrazine Subjects were maintained on placebo for approximately 2 weeks, then they were crossed over to 210 mg phendimetrazine daily for approximately 2 weeks.	Phendimetrazine First, Then Placebo Subjects were maintained on 210 mg phendimetrazine for approximately 2 weeks, then they were crossed over to placebo daily for approximately 2 weeks.
Overall Study Adverse Event	0	1

Baseline Characteristics

Reinforcing Effects of Cocaine During Phendimetrazine Maintenance

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Completers n=29 Participants Baseline demographics for study completers
Age, Continuous	46 years STANDARD_DEVIATION 4 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	21 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants

PRIMARY outcome

Timeframe: After at least seven days of maintenance placebo or target phendimetrazine dose

Outcome measures

Outcome measures
Measure	Placebo n=29 Participants Subjects were maintained on Placebo for at least 7 days.	Phendimetrazine n=29 Participants Subjects were maintained on 210 mg Phendimetrazine for at least 7 days.
Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative 0 mg Cocaine	.34 Cocaine Choices Standard Error .34	.24 Cocaine Choices Standard Error .15
Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative 20 mg Cocaine	4.31 Cocaine Choices Standard Error .81	3.9 Cocaine Choices Standard Error .85
Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative 40 mg Cocaine	4.69 Cocaine Choices Standard Error .89	3.83 Cocaine Choices Standard Error .85
Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative 80 mg Cocaine	5.90 Cocaine Choices Standard Error .8	5.03 Cocaine Choices Standard Error .87

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Phendimetrazine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

William W. Stoops

University of Kentucky

Phone: 859-257-5388

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place