Actively Recruiting

Phase 3
Age: 18Years +
All Genders
Healthy Volunteers
NCT06306443

Buprenorphine for Individuals in Jail

Led by Friends Research Institute, Inc. · Updated on 2026-02-03

240

Participants Needed

2

Research Sites

234 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is an open label randomized controlled trial of extended-release buprenorphine (BRIXADI, XR-B) vs. sublingual buprenorphine (SL-B) in a large metropolitan jail. An open-label design will randomly assign 240 adults with moderate-to-severe OUDs who are soon-to-be-released from jail to either XR-B (n=120) or SL-B (n=120) treatment in jail followed by 6-months of post-release buprenorphine treatment, a 7-month safety visit, and a final long-term follow-up at 12-months.

CONDITIONS

Official Title

Buprenorphine for Individuals in Jail

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult male or female inmates at participating jail who are eligible for release within 120 days (sentenced and/or pretrial; individuals who might be sentenced to state/federal prison will be excluded)
  • Individuals completing their sentence in the community under probation, parole, home detention, electronic monitoring, drug or other treatment court (or equivalent) are eligible
  • History of moderate or severe opioid use disorder (DSM-5 criteria) at incarceration, or treated in opioid agonist program during the year before incarceration
  • Medically suitable for extended-release or sublingual buprenorphine treatment
  • Willing to enroll in buprenorphine treatment in jail and continue after release
  • Planning to live in Baltimore City or the Baltimore Region
Not Eligible

You will not qualify if you...

  • Liver function test levels greater than 5 times normal (or as determined by study physician if labs unavailable)
  • Active medical illness that may make participation hazardous (e.g., unstable diabetes, heart disease, moderate to severe renal impairment); adequately treated conditions allowed
  • Conditions or medications that may cause QTc prolongation (e.g., long QT syndrome, hypokalemia, certain antibiotics, antifungals, anti-arrhythmics, antipsychotics, antidepressants)
  • Untreated psychiatric disorders that may make participation hazardous (e.g., untreated psychosis, bipolar disorder with mania); adequately treated disorders and psychotropic medications allowed
  • History of allergic reaction to buprenorphine
  • Suicidal ideation within the past 6 months
  • Inability to pass a study enrollment quiz
  • Currently receiving non-buprenorphine medication for opioid use disorder in jail (e.g., methadone, naltrexone)

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Friends Research Institute

Baltimore, Maryland, United States, 21201

Actively Recruiting

2

Baltimore Central Booking & Intake Center

Baltimore, Maryland, United States, 21202

Actively Recruiting

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Research Team

M

Michael Gordon, DPA

CONTACT

T

Thomas R Blue, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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