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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to month 9

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to month 9

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of participants released from jail with at least 7 days of buprenorphine in their system

Secondary outcome measures

Percentage of participants continuing MOUD treatment in the community

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,367 Previous Clinical Trials

839,521 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,465 Previous Clinical Trials

2,618,433 Total Patients Enrolled

David Farabee, PhDPrincipal InvestigatorNYU Langone Health

2 Previous Clinical Trials

151 Total Patients Enrolled

Frequently Asked Questions

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

Is this experiment presently accepting new participants?

"Based on the information available through clinicaltrials.gov, this medical study is not currently accepting patients into its trials. Initially posted on May 1st 2024 and most recently updated on September 18th 2023, there are however 288 other studies actively seeking volunteers for their research right now."

Answered by AI

What are the potential harm-reduction benefits of Transition to Extended-Release Buprenorphine (XRB)?

"Due to its approval status, XRB is deemed safe enough to score a 3 on our team's 1-3 scale. This safety rating is especially true since this is a Phase 4 trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Assessing Optimal XRB Initiation Points in Jail

2024. "Assessing Optimal XRB Initiation Points in Jail". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06051890.

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