Trial Outcomes & Findings for Influence of Medication on Functional Connectivity (NCT NCT03612713)

Last Updated: 2024-03-08

Results Overview

Functional connectivity is measured by functional magnetic resonance imagery (fMRI). Change in functional connectivity (a statistical relationship between two regions in the brain) between placebo and oxycodone fMRI scans will be assessed. Result is a transformed z-score. A score of 0 indicates no change. Higher scores indicate increased connectivity.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

20 participants

Primary outcome timeframe

Change in functional connectivity from initial fMRI scan to follow-up MRI scan, up to 4 weeks.

Results posted on

2024-03-08

Participant Flow

Participant milestones

Participant milestones
Measure	Oxycodone Medication First one hour before fMRI scan participants will be given a single dose 15mg immediate release oxycodone Oxycodone Medication First: Participants will be given 15mg oxycodone one hour before fMRI scan. After at least 1 week wash out participants will be given placebo one hour before fMRI scan.	Placebo First one hour before fMRI scan participants will be given a single dose placebo. Placebo First: Participants will be given placebo one hour before fMRI scan. After at least 1 week wash out participants will be given 15mg oxycodone one hour before fMRI scan.
Overall Study STARTED	10	10
Overall Study COMPLETED	7	8
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Influence of Medication on Functional Connectivity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oxycodone Medication First n=10 Participants one hour before fMRI scan participants will be given a single dose 15mg immediate release oxycodone Oxycodone Medication First: Participants will be given 15mg oxycodone one hour before fMRI scan. After at least 1 week wash out participants will be given placebo one hour before fMRI scan.	Placebo First n=10 Participants one hour before fMRI scan participants will be given a single dose placebo. Placebo First: Participants will be given placebo one hour before fMRI scan. After at least 1 week wash out participants will be given 15mg oxycodone one hour before fMRI scan.	Total n=20 Participants Total of all reporting groups
Age, Continuous	24.20 years STANDARD_DEVIATION 2.82 • n=5 Participants	24.40 years STANDARD_DEVIATION 2.95 • n=7 Participants	24.30 years STANDARD_DEVIATION 2.81 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	5 Participants n=5 Participants	3 Participants n=7 Participants	8 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 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	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Change in functional connectivity from initial fMRI scan to follow-up MRI scan, up to 4 weeks.

Population: Positive and Negative connectivity within the ventral attention network

Outcome measures

Outcome measures
Measure	Oxycodone Run n=12 Participants one hour before fMRI scan participants will be given a single dose 15mg immediate release oxycodone	Placebo Run n=12 Participants one hour before fMRI scan participants will be given a placebo dose
Change in Functional Connectivity Following Oxycodone Administration Positive network strength for connectivity within the ventral attention network	2.66 z-score Standard Deviation 1.37	4.55 z-score Standard Deviation 2.46
Change in Functional Connectivity Following Oxycodone Administration Negative network strength for connectivity within the ventral attention network	.99 z-score Standard Deviation .88	1.60 z-score Standard Deviation .54

Adverse Events

Oxycodone Medication

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Oxycodone Medication n=20 participants at risk one hour before fMRI scan participants will be given a single dose 15mg immediate release oxycodone	Placebo n=20 participants at risk one hour before fMRI scan participants will be given a single dose placebo.
General disorders Nausea and vomiting	10.0% 2/20 • Number of events 3 • up to 4 weeks	10.0% 2/20 • Number of events 2 • up to 4 weeks

Additional Information

Data Manager

Yale University School of Medicine

Phone: 203-737-5430

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place