Trial Outcomes & Findings for Impact of a Non-Drug Choice on Cocaine Reinforcement (NCT NCT01906346)

NCT ID: NCT01906346

Last Updated: 2019-05-17

Results Overview

The reinforcing effects of cocaine were determined using a modified progressive ratio procedure in which subjects made 9 choices between each available cocaine dose and one of three money alternatives.

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 9 participants
• Primary outcome timeframe: 9 choice trials per cocaine dose level with each trial separated by 30 minutes
• Results posted on: 2019-05-17

Participant Flow

Participant milestones

Measure	Randomized Combination of One Drug Dose and One Money Value Low, medium and high value monetary reinforcers are made available as an alternative to cocaine and placebo during experimental sessions. Cocaine: Three active doses of cocaine are made available for self-administration during experimental sessions. Placebo: Placebo cocaine is made available for self-administration during experimental sessions.
Overall Study STARTED	9
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure

Randomized Combination of One Drug Dose and One Money Value Low, medium and high value monetary reinforcers are made available as an alternative to cocaine and placebo during experimental sessions. Cocaine: Three active doses of cocaine are made available for self-administration during experimental sessions. Placebo: Placebo cocaine is made available for self-administration during experimental sessions.

Overall Study AEs

1

Baseline Characteristics

Impact of a Non-Drug Choice on Cocaine Reinforcement

Baseline characteristics by cohort

Measure	Randomized Combination of One Drug Dose and One Money Value n=9 Participants Low, medium and high value monetary reinforcers are made available as an alternative to cocaine and placebo during experimental sessions. Cocaine: Three active doses of cocaine are made available for self-administration during experimental sessions. Placebo: Placebo cocaine is made available for self-administration during experimental sessions.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	3 Participants n=93 Participants
Sex: Female, Male Male	6 Participants n=93 Participants
Region of Enrollment United States	9 participants n=93 Participants

PRIMARY outcome

Timeframe: 9 choice trials per cocaine dose level with each trial separated by 30 minutes

The reinforcing effects of cocaine were determined using a modified progressive ratio procedure in which subjects made 9 choices between each available cocaine dose and one of three money alternatives.

Outcome measures

Measure	Low Value Alternative Reinforcer n=8 Participants A low value reinforcer was made available as an alternative to cocaine and placebo. Cocaine: Three active doses of cocaine will be made available for self-administration during experimental sessions. Placebo: Placebo cocaine will be made available for self-administration during experimental sessions.	Medium Value Reinforcer n=8 Participants A medium value reinforcer was made available as an alternative to cocaine and placebo. Cocaine: Three active doses of cocaine will be made available for self-administration during experimental sessions. Placebo: Placebo cocaine will be made available for self-administration during experimental sessions.	High Value Reinforcer n=8 Participants A high value reinforcer was made available as an alternative to cocaine and placebo. Cocaine: Three active doses of cocaine will be made available for self-administration during experimental sessions. Placebo: Placebo cocaine will be made available for self-administration during experimental sessions.
The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative Placebo Cocaine	2.75 cocaine choices Standard Error 1.39	1.38 cocaine choices Standard Error 0.53	1.38 cocaine choices Standard Error 0.53
The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative 3 mg/70 kg Cocaine	4.75 cocaine choices Standard Error 1.24	5.88 cocaine choices Standard Error 1.17	4.00 cocaine choices Standard Error 1.52
The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative 10 mg/70 kg Cocaine	7.38 cocaine choices Standard Error 1.07	6.13 cocaine choices Standard Error 1.47	6.38 cocaine choices Standard Error 1.41
The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative 30 mg/70kg Cocaine	7.63 cocaine choices Standard Error 1.12	7.13 cocaine choices Standard Error 1.13	6.38 cocaine choices Standard Error 1.22

Adverse Events

Randomized Combination of One Drug Dose and One Money Value

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Randomized Combination of One Drug Dose and One Money Value n=9 participants at risk Low, medium and high value monetary reinforcers are made available as an alternative to cocaine and placebo during experimental sessions. Cocaine: Three active doses of cocaine are made available for self-administration during experimental sessions. Placebo: Placebo cocaine is made available for self-administration during experimental sessions.
Gastrointestinal disorders Nausea and vomiting	11.1% 1/9 • Number of events 3 • 15 days per subject. Adverse event reporting consists of each experimental session in which a single cocaine dose and monetary reinforcer were available as choice alternatives, as well as during the conduct of a medical safety session in which cocaine doses are administered prior to choice sessions.
Investigations Difficulty obtaining IV line	11.1% 1/9 • 15 days per subject. Adverse event reporting consists of each experimental session in which a single cocaine dose and monetary reinforcer were available as choice alternatives, as well as during the conduct of a medical safety session in which cocaine doses are administered prior to choice sessions.

Additional Information

Joshua A. Lile, Ph.D.

University of Kentucky

Phone: 859-420-0503

Email: jalile2@uky.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place