Recruiting

XRB vs. SLB

Sponsor:

NYU Langone Health

Code:

NCT06051890

Conditions

Opioid Use Disorder

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Extended-Release Buprenorphine (XRB)

Sublingual Buprenorphine (SLB)

Study Details

Brief summary:

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

Opioid Use Disorder

Study ID

NCT06051890

Start date

Jun 2, 2025

Status verified date

Aug, 2026

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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).

Exclusion Criteria:

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Transition to Extended-Release Buprenorphine (XRB)

Participants randomized to transition to treatment with XRB.

active comparator: Sublingual Buprenorphine (SLB) Maintenance

Participants randomized to remain on-treatment with SLB.

Interventions

Extended-Release Buprenorphine (XRB)

XRB (Sublocade) will be delivered as a pre-filled 2cc subcutaneous monthly injection, using a 300mg starting dose in most cases (100mg starting doses are available per the study team's clinical judgement). XRB consists of a depot injectable formulation in polymeric solution to the abdomen and releases buprenorphine over 28-days (4-weeks) by diffusion as the polymer biodegrades. Prior to an initial injection, the participant must be stable for several days or longer on sublingual buprenorphine (SLB) at doses of 8mg/day or higher. Participants will receive at least one XRB monthly injection prior to release, which investigators anticipate to usually be the 300mg dose. Some participants will be recruited earlier during the incarceration (or experience delayed release dates and then longer than anticipated incarcerations); XRB will be continued monthly from the time of induction to the day of release.

Sublingual Buprenorphine (SLB)

Maintenance of existing SLB prescription (treatment as usual).

Primary outcome measure

  • Percentage of participants released from jail with at least 7 days of buprenorphine in their system [ Time Frame: Up to Month 6 ]

Central Contacts and Locations

Central contacts

David Farabee

310-963-0009David.farabee@nyulagone.org

Locations

Tufts University Health Sciences

Recruiting

Boston, Massachusetts, United States, 02111

Principal Investigator:

Thomas Stopka, Ph.D.

Baystate Health

Recruiting

Springfield, Massachusetts, United States, 01199

Principal Investigator:

Peter Friedmann, MD

Middlesex County House of Corrections

Recruiting

New Brunswick, New Jersey, United States, 08902

Contacts

732-297-3636

Principal Investigator:

Kashif Siddiqi

NYU Langone Health - 180 Madison Ave

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-08-07.