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Opioid Agonist

XR-Buprenorphine Initiation Strategies for Opioid Use Disorder in Jail

Phase 4
Waitlist Available
Led By David Farabee, PhD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Incarcerated adults able to provide written informed consent in English
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months post-release (up to month 10)
Awards & highlights

Study Summary

This trial will compare two approaches for starting buprenorphine treatment for opioid use disorder among jail inmates. Inmates will either start treatment at the time of admission or shortly before release. Researchers will compare how likely inmates are to participate in treatment, levels of in-jail opioid use, continuation of pharmacotherapy and other OUD treatment in the community, and levels of opioid use 4 and 12 weeks following discharge.

Who is the study for?
This trial is for incarcerated adults with moderate-to-severe opioid use disorder who can consent in English and have a release date within 3-7 months. They should be likely to continue treatment after release, not planning to transfer facilities, and not on methadone or buprenorphine maintenance. Those with severe health issues, pregnant women, or individuals requiring opioid pain management are excluded.Check my eligibility
What is being tested?
The study tests when it's best to start extended-release buprenorphine (XR-B) for opioid addiction in jail: at admission or just before release. It will compare the willingness to begin treatment, levels of opioid use while jailed and post-release, continuation of therapy outside jail, and drug use up to 12 weeks after discharge.See study design
What are the potential side effects?
Extended-release buprenorphine may cause side effects like nausea, headache, sweating, constipation, insomnia and possibly liver problems. Some people might also experience injection site reactions such as pain or itching.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am incarcerated but can sign a consent form in English.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months post-release (up to month 10)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months post-release (up to month 10) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of Participants who Receive XR-B within 28 Days Prior to Jail Release
Secondary outcome measures
Mean K-6 Distress Scale Score during Incarceration Period
Mean Opioid Craving Visual Analogue Scale (OC-VAS) Score during Incarceration Period
Number of Days of Opioid Use at 1 Month Post-Release
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: XR-B Induction at Pre-ReleaseExperimental Treatment1 Intervention
Participants will initiate extended-release buprenorphine (XR-B) treatment within 30 days of release. Participants will receive at least one XR-B monthly injection prior to release, and XR-B will be continued monthly from the time of induction to the day of release. Up to 3 monthly injections will be offered in the community following release. Dosing: XR-B is available in two doses, 300mg and 100mg. Study clinicians will generally adhere to FDA-labeling on XR-B dosing, which recommends two months of 300-mg doses followed by maintenance doses of 100-mg monthly.
Group II: XR-B Induction at AdmissionExperimental Treatment1 Intervention
Participants will initiate extended-release buprenorphine (XR-B) treatment at the time of admission. XR-B will be continued monthly from the time of induction to the day of release (up to 6 months), and up to 3 monthly injections will be offered in the community following release. Dosing: XR-B is available in two doses, 300mg and 100mg. Study clinicians will generally adhere to FDA-labeling on XR-B dosing, which recommends two months of 300-mg doses followed by maintenance doses of 100-mg monthly.

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,447 Previous Clinical Trials
2,594,066 Total Patients Enrolled
NYU Langone HealthLead Sponsor
1,358 Previous Clinical Trials
816,813 Total Patients Enrolled
David Farabee, PhDPrincipal InvestigatorNYU Langone Medical Center
2 Previous Clinical Trials
351 Total Patients Enrolled

Media Library

Extended-Release Buprenorphine Injection (Opioid Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05481112 — Phase 4
Opioid Use Disorder Research Study Groups: XR-B Induction at Pre-Release, XR-B Induction at Admission
Opioid Use Disorder Clinical Trial 2023: Extended-Release Buprenorphine Injection Highlights & Side Effects. Trial Name: NCT05481112 — Phase 4
Extended-Release Buprenorphine Injection (Opioid Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05481112 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an opportunity for me to take part in this clinical investigation?

"This study seeks 180 subjects with a diagnosis of opioid abuse disorder between the ages 18 and 65. In order to qualify, they must be incarcerated, able to sign informed consent in English, have an expected release date within 3-7 months, exhibit reasonable prospects for completing 3+ months of post-release treatment, agree to randomly assigned timing for XR-B medication intake upon jail entry or shortly after release date, and demonstrate signs of moderate-to-severe OUD (DSM 5)."

Answered by AI

Are any new participants being sought for this clinical trial?

"Per clinicaltrials.gov, enrollment for this trial has been suspended since August 17th, 2022 when the post was last updated after being initially published on November 1st of the same year. Nevertheless, 291 other trials are still scouting for participants currently."

Answered by AI

Does eligibility for this trial encompass participants under the age of 65?

"This medical trial has a limited age range, namely 18-65. However, there are other studies available for those outside this window - 22 trials open to minors and 240 open to seniors."

Answered by AI

What are the goals of this clinical evaluation?

"The primary outcome of this study will be monitored for up to 10 months, and it is the number of participants who receive the first dose of XR-B during incarceration. Secondary metrics include: a percentage breakdown that evaluates opioid use at 3 months post-release based on composite urine toxicology results and self-reported drug use through TLFB; an analogous measure taken 1 month after release; and finally, total days of opioid utilization reported by patients in TLFB surveys 3 months post-release."

Answered by AI

What potential risks can be associated with Extended-Release Buprenorphine Injection?

"Due to its Phase 4 designation, Extended-Release Buprenorphine Injection was assigned a security rating of 3 out of 3. This represents the highest level of safety given that it has been approved for medical use."

Answered by AI
~0 spots leftby Nov 2025