Trial Outcomes & Findings for Re-entry XR-NTX for Rural Individuals With Opioid Use Disorder (NCT NCT03447743)

NCT ID: NCT03447743

Last Updated: 2023-03-27

Results Overview

Study enrollment is defined as the number of participants who initiate XR-NTX.

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 9 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2023-03-27

Participant Flow

Participant milestones

Measure	Extended Release Naltrexone (XR-NTX) Services as Usual Participants will receive on-going XR-NTX injections in a local community clinic XR-NTX community location: XR-NTX will be administered at the local health care clinic
Overall Study STARTED	9
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	Extended Release Naltrexone (XR-NTX) Services as Usual Participants will receive on-going XR-NTX injections in a local community clinic XR-NTX community location: XR-NTX will be administered at the local health care clinic
Overall Study Withdrawal by Subject	2
Overall Study Lost to Follow-up	3
Overall Study Adverse Event	1
Overall Study Did not meet criteria to continue	1

Baseline Characteristics

Re-entry XR-NTX for Rural Individuals With Opioid Use Disorder

Baseline characteristics by cohort

Measure	Extended Release Naltrexone (XR-NTX) Services as Usual n=9 Participants Participants will receive on-going XR-NTX injections in a local community clinic XR-NTX community location: XR-NTX will be administered at the local health care clinic
Ever Overdosed	6 Participants n=5 Participants
Age, Continuous	36.1 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	9 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	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants
Ever Been in a Substance Use Treatment Program	5 Participants n=5 Participants
Ever Prescribed Medication for Opioid Use Disorder	4 Participants n=5 Participants
Ever Injected any Drug	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Study enrollment is defined as the number of participants who initiate XR-NTX.

Outcome measures

Measure	XR-NTX Services as Usual n=9 Participants Participants will receive on-going XR-NTX injections in a local community clinic XR-NTX community location: XR-NTX will be administered at the local health care clinic
Study Enrollment	7 Participants

SECONDARY outcome

Timeframe: 3 months

The short-term outcome of interest includes any relapse to opioid use (any use of opioids by self-report and urine drug screen; continuous measure of number of days of use).

Outcome measures

Measure	XR-NTX Services as Usual n=9 Participants Participants will receive on-going XR-NTX injections in a local community clinic XR-NTX community location: XR-NTX will be administered at the local health care clinic
Number of Participants With Opioid Relapse	3 Participants

Adverse Events

XR-NTX Services as Usual

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	XR-NTX Services as Usual n=9 participants at risk Participants will receive on-going XR-NTX injections in a local community clinic XR-NTX community location: XR-NTX will be administered at the local health care clinic
Hepatobiliary disorders Hospitalization	11.1% 1/9 • Number of events 1 • 3 months AEs were assessed by medical staff and at follow-up based on participant self-report.
Injury, poisoning and procedural complications Hospitalization	11.1% 1/9 • Number of events 1 • 3 months AEs were assessed by medical staff and at follow-up based on participant self-report.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michele Staton

University of Kentucky

Phone: 859-312-8245

Email: mstaton@uky.edu

Results disclosure agreements

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