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Opioid Agonist

Buprenorphine Formulations 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 men able to provide written informed consent in English
Must not have
Chronic pain requiring opioid pain management or other contraindicated medications
Allergy, hypersensitivity or medical contraindication to either medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to month 9
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial will compare two different treatments for adults in jail with existing buprenorphine prescriptions to see which works better to keep them on treatment and prevent buprenorphine diversion.

Who is the study for?
This trial is for unsentenced men entering Middlesex County House of Corrections with an existing prescription for Sublingual Buprenorphine (SLB), having taken it for at least 3 days, and willing to be randomly assigned to a new treatment. They must understand English, agree to the study's terms, and expect to stay in jail for at least 4 days. Those with chronic pain needing opioids or allergies to the medications cannot join.
What is being tested?
The study compares two treatments for opioid addiction in jailed individuals: one group will switch from SLB to Extended-Release Buprenorphine (XRB) upon admission, while the other remains on SLB. The goal is to see which method is better at ensuring participants have medication when released, continue treatment outside jail, and reduce drug-related infractions.
What are the potential side effects?
Possible side effects include nausea, vomiting, constipation, headaches, sweating, insomnia related to buprenorphine use; however specific side effects related directly from transitioning between SLB and XRB are not detailed.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I need opioids or similar medications to manage my chronic pain.
Select...
I am allergic or have a bad reaction to certain medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to month 9
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to month 9 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of participants released from jail with at least 7 days of buprenorphine in their system
Secondary study objectives
Percentage of participants continuing MOUD treatment in the community

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Transition to Extended-Release Buprenorphine (XRB)Experimental Treatment1 Intervention
Participants randomized to transition to treatment with XRB.
Group II: Sublingual Buprenorphine (SLB) MaintenanceActive Control1 Intervention
Participants randomized to remain on-treatment with SLB.

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,586 Previous Clinical Trials
3,328,330 Total Patients Enrolled
NYU Langone HealthLead Sponsor
1,409 Previous Clinical Trials
855,385 Total Patients Enrolled
David Farabee, PhDPrincipal InvestigatorNYU Langone Health
2 Previous Clinical Trials
151 Total Patients Enrolled
~133 spots leftby Jun 2026
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