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Taking people in United StatesPhase 4

Assessing Optimal XRB Initiation Points in Jail

Key facts

Who runs it
NYU Langone Health
Where
Boston, New Brunswick, New York, and Springfield, United StatesSee the 4 sites
Trial code
Status
Recruiting
Phase
Phase 4
People taking part
50 people, planned
Started
2 Jun 2025
Expected to end
1 Mar 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Extended-Release Buprenorphine (XRB)
  • Sublingual Buprenorphine (SLB)
Record updated
7 August 2026

Who can take part

Sex
Men only
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • Incarcerated men able to provide written informed consent in English.*
  • Unsentenced
  • Entering the facility with a prescription for SLB and receiving SLB for at least the previous 3 days
  • Minimum anticipated jail stay is 4 days
  • Willing to accept being randomized to the experimental condition (i.e., transitioning to XRB while incarcerated)

Who cannot take part

  • Chronic pain requiring opioid pain management or other contraindicated medications
  • Allergy, hypersensitivity or medical contraindication to either medication
  • Sentenced

Where in United States

  • Tufts University Health SciencesBoston, United StatesContact: Thomas Stopka, Ph.D. (principal investigator)Taking people
  • Middlesex County House of CorrectionsNew Brunswick, United StatesContact: Kashif Siddiqi (principal investigator)Taking people
  • NYU Langone Health - 180 Madison AveNew York, United StatesContact: David FarabeeTaking people
  • Baystate HealthSpringfield, United StatesContact: Peter Friedmann, MD (principal investigator)Taking people

About the trial

What the trial wants to find out

This application describes a 3-year, randomized controlled trial. Eligible, consenting adults (N=200) with existing sublingual buprenorphine (SLB) prescriptions who enter Middlesex County House of Corrections (MCHOC) as pre-trial detainees will be randomized at admission on a 1:1 basis to be inducted onto extended-release buprenorphine (XRB) at the time of admission (experimental condition) or remain in SLB (E-TAU; all participants will also receive naloxone). The two approaches will be compared with regard to (1) the percentage of participants released from jail with at least 7 days of buprenorphine in their system, (2) percentage of participants continuing MOUD treatment in the community, and (3) infractions related to buprenorphine diversion.

The 2 groups in the trial

  • Transition to Extended-Release Buprenorphine (XRB)Treatment being tested

    Participants randomized to transition to treatment with XRB.

    Treatment: Extended-Release Buprenorphine (XRB)

  • Sublingual Buprenorphine (SLB) MaintenanceExisting treatment, for comparison

    Participants randomized to remain on-treatment with SLB.

    Treatment: Sublingual Buprenorphine (SLB)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Assessing Optimal Extended-Release Buprenorphine (XRB) Initiation Points in Jail
Record updated
7 August 2026