Extended-Release Buprenorphine Injection for Opioid Use Disorder (OUD)

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
NYU Langone Health, New York, NY
Opioid Use Disorder (OUD)+1 More
Extended-Release Buprenorphine Injection - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The goal of this study is to compare two approaches for commencing pharmacotherapy with injectable buprenorphine for opioid use disorder (OUD) among jail inmates: (1) at the time of admission or (2) shortly before release. A sample of eligible inmates with sentences of less than 180 days will be randomly assigned to (1) initiating extended-release buprenorphine (XR-B) treatment at the time of admission (n=80), or (2) initiating XR-B treatment within 30 prior to their scheduled release date (n=80). The groups will be compared with regard to (1) how likely they were to participate in treatment, (2) levels of in-jail opioid use (via post-release interviews), (3) continuation of pharmacotherapy and other OUD treatment in the community, and (4) levels of opioid use 4 and 12 weeks following discharge (self-report and incentivized voluntary urine tests).

Eligible Conditions

  • Opioid Use Disorder (OUD)

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

4 Primary · 9 Secondary · Reporting Duration: 3 Months Post-Release (Up to Month 10)

Month 7
Number of Days of Opioid Use at 1 Month Post-Release
Percentage of Participants who Test Positive for Opioid Use at 1 Month Post-Release
Proportion of Participants who Receive a Dose of XR-B Within 28 Days after Jail Release
Month 10
Number of Days of Opioid Use at 3 Months Post-Release
Percentage of Participants who Test Positive for Opioid Use at 3 Months Post-Release
Up to Month 10
Number of Doses of XR-B Administered after Release
Number of Participants who Initiate Medication for Opioid Use Disorder (MOUD)
Up to Month 6
Mean K-6 Distress Scale Score during Incarceration Period
Mean Opioid Craving Visual Analogue Scale (OC-VAS) Score during Incarceration Period
Number of Doses of XR-B Administered while Incarcerated
Number of Participants who Receive First Dose of XR-B while Incarcerated
Proportion of Participants who Initiate Medication for Opioid Use Disorder (MOUD) during Incarceration Period
Proportion of Participants who Receive XR-B within 28 Days Prior to Jail Release

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

XR-B Induction at Pre-Release
1 of 2
XR-B Induction at Admission
1 of 2
Experimental Treatment

180 Total Participants · 2 Treatment Groups

Primary Treatment: Extended-Release Buprenorphine Injection · No Placebo Group · Phase 4

XR-B Induction at Pre-Release
Drug
Experimental Group · 1 Intervention: Extended-Release Buprenorphine Injection · Intervention Types: Drug
XR-B Induction at Admission
Drug
Experimental Group · 1 Intervention: Extended-Release Buprenorphine Injection · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months post-release (up to month 10)
Closest Location: NYU Langone Health · New York, NY
Photo of NYU Langone Health 1Photo of NYU Langone Health 2Photo of NYU Langone Health 3
2020First Recorded Clinical Trial
3 TrialsResearching Opioid Use Disorder (OUD)
107 CompletedClinical Trials

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,203 Previous Clinical Trials
5,610,299 Total Patients Enrolled
124 Trials studying Opioid Use Disorder (OUD)
4,679,127 Patients Enrolled for Opioid Use Disorder (OUD)
NYU Langone HealthLead Sponsor
1,235 Previous Clinical Trials
749,666 Total Patients Enrolled
11 Trials studying Opioid Use Disorder (OUD)
14,995 Patients Enrolled for Opioid Use Disorder (OUD)
David Farabee, PhDPrincipal InvestigatorNYU Langone Medical Center
1 Previous Clinical Trials
151 Total Patients Enrolled
1 Trials studying Opioid Use Disorder (OUD)
151 Patients Enrolled for Opioid Use Disorder (OUD)

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are an adult who is incarcerated
You have a current opioid use disorder.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.