Assessing Optimal XRB Initiation Points in Jail

NCT06051890 — Phase 4, Recruiting, 50 participants, NYU Langone Health

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Assessing Optimal Extended-Release Buprenorphine (XRB) Initiation Points in Jail

Registry	NCT06051890
Status	Recruiting
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	50 (Estimated)
Sponsor	NYU Langone Health (Other); collaborators: National Institute on Drug Abuse (NIDA)
Conditions	Opioid Use Disorder
Interventions	Extended-Release Buprenorphine (XRB), Sublingual Buprenorphine (SLB) (Drug)
Dates	start 2025-06-02, primary completion 2026-12-01 (estimated), completion 2027-03-01 (estimated), first posted 2023-09-25, last updated 2026-08-07
Locations	4 sites in United States

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Transition to Extended-Release Buprenorphine (XRB)	Experimental	Drug: Extended-Release Buprenorphine (XRB)	Participants randomized to transition to treatment with XRB.
Sublingual Buprenorphine (SLB) Maintenance	Active comparator	Drug: Sublingual Buprenorphine (SLB)	Participants randomized to remain on-treatment with SLB.

Extended-Release Buprenorphine (XRB) (Drug), also known as Sublocade: 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) (Drug): Maintenance of existing SLB prescription (treatment as usual).

+Outcome measures

Primary outcomes

Percentage of participants released from jail with at least 7 days of buprenorphine in their system [Up to Month 6]: The percentage of participants leaving jail with at least 7 days of buprenorphine protection in their system. Measured using clinical and jail records.

Secondary outcomes

Percentage of participants continuing MOUD treatment in the community [Up to Month 9]: Percentage of participants who continue to access medication for opioid use disorder (MOUD) once released from jail. This will be based on community clinic records indicating admission and retention.

+Eligibility

Sex: Male

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.

+Locations (4)

Facility	City	Country	Status
Tufts University Health Sciences	Boston, Massachusetts	United States	Recruiting
Baystate Health	Springfield, Massachusetts	United States	Recruiting
Middlesex County House of Corrections	New Brunswick, New Jersey	United States	Recruiting
NYU Langone Health - 180 Madison Ave	New York, New York	United States	Recruiting

+Investigators

David Farabee, PhD, Principal investigator, NYU Langone Health