Actively Recruiting

Phase 4
MALE
NCT06051890

Assessing Optimal XRB Initiation Points in Jail

Led by NYU Langone Health · Updated on 2025-09-10

200

Participants Needed

4

Research Sites

91 weeks

Total Duration

On this page

Sponsors

N

NYU Langone Health

Lead Sponsor

N

National Institute on Drug Abuse (NIDA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Assessing Optimal XRB Initiation Points in Jail

Who Can Participate

MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Incarcerated men able to provide written informed consent in English
  • Unsentenced (pre-trial detainees)
  • Entering the facility with a prescription for sublingual buprenorphine and receiving it for at least the previous 3 days
  • Minimum anticipated jail stay of 4 days
  • Willing to accept randomization to either continue sublingual buprenorphine or transition to extended-release buprenorphine injection
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 4 locations

1

Tufts University Health Sciences

Boston, Massachusetts, United States, 02111

Actively Recruiting

2

Baystate Health

Springfield, Massachusetts, United States, 01199

Actively Recruiting

3

Middlesex County House of Corrections

New Brunswick, New Jersey, United States, 08902

Actively Recruiting

4

NYU Langone Health - 180 Madison Ave

New York, New York, United States, 10016

Actively Recruiting

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Research Team

D

David Farabee

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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Assessing Optimal XRB Initiation Points in Jail | DecenTrialz