Trial Outcomes & Findings for The Effect of Glutamatergic Modulation on Cocaine Self-administration (NCT NCT02596022)

NCT ID: NCT02596022

Last Updated: 2018-06-15

Results Overview

Participants provided 5 choices (cocaine 25 mg now vs. $11 later), with choices spaces 15 minutes apart over the course of the session.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 18 participants
• Primary outcome timeframe: 24 hours post-infusion
• Results posted on: 2018-06-15

Participant Flow

Participant milestones

Measure	CI-581a First, Followed by CI-581b Administration of CI-581a followed 2 weeks later by CI-581b CI-581a: a 50 minute infusion 24 hours prior to cocaine self-administration session CI-581b: a 50 minute infusion 24 hours prior to cocaine self-administration session	CI-581b First, Followed by CI-581a Administration of CI-581b followed 2 weeks later by CI-581a CI-581a: a 50 minute infusion 24 hours prior to cocaine self-administration session CI-581b: a 50 minute infusion 24 hours prior to cocaine self-administration session
Overall Study STARTED	10	8
Overall Study COMPLETED	10	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Glutamatergic Modulation on Cocaine Self-administration

Baseline characteristics by cohort

Measure	CI-581a First, Followed by CI-581b n=10 Participants Administration of CI-581a followed 2 weeks later by CI-581b CI-581a: a 50 minute infusion 24 hours prior to cocaine self-administration session CI-581b: a 50 minute infusion 24 hours prior to cocaine self-administration session	CI-581b First, Followed by CI-581a n=8 Participants Administration of CI-581b followed 2 weeks later by CI-581a CI-581a: a 50 minute infusion 24 hours prior to cocaine self-administration session CI-581b: a 50 minute infusion 24 hours prior to cocaine self-administration session	Total n=18 Participants Total of all reporting groups
Age, Continuous	48.6 years STANDARD_DEVIATION 6.1 • n=5 Participants	48.6 years STANDARD_DEVIATION 6.1 • n=7 Participants	48.6 years STANDARD_DEVIATION 6.1 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours post-infusion

Participants provided 5 choices (cocaine 25 mg now vs. $11 later), with choices spaces 15 minutes apart over the course of the session.

Outcome measures

Measure	CI-581a n=18 Participants CI-581a: a 50 minute infusion 24 hours prior to cocaine self-administration session	CI-581b n=18 Participants CI-581a: a 50 minute infusion 24 hours prior to cocaine self-administration session
Number of Choices to Self-administer Cocaine (Out of 5 Choices)	1.61 number of cocaine choices Standard Deviation 1.3	4.33 number of cocaine choices Standard Deviation 1.8

Adverse Events

CI-581a First, Followed by CI-581b

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CI-581b First, Followed by CI-581a

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

Linda Sherman

NYSPI

Phone: 6467747158

Email: lsherma@nyspi.columbia.edu

Results disclosure agreements

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