Assessing Optimal XRB Initiation Points in Jail
Assessing Optimal Extended-Release Buprenorphine (XRB) Initiation Points in Jail
1 other identifier
interventional
200
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2025
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2023
CompletedFirst Posted
Study publicly available on registry
September 25, 2023
CompletedStudy Start
First participant enrolled
June 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
September 10, 2025
September 1, 2025
1.5 years
September 18, 2023
September 8, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of participants released from jail with at least 7 days of buprenorphine in their system
The percentage of participants leaving jail with at least 7 days of buprenorphine protection in their system. Measured using clinical and jail records.
Up to Month 6
Secondary Outcomes (1)
Percentage of participants continuing MOUD treatment in the community
Up to Month 9
Study Arms (2)
Transition to Extended-Release Buprenorphine (XRB)
EXPERIMENTALParticipants randomized to transition to treatment with XRB.
Sublingual Buprenorphine (SLB) Maintenance
ACTIVE COMPARATORParticipants randomized to remain on-treatment with SLB.
Interventions
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.
Maintenance of existing SLB prescription (treatment as usual).
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Sentenced.
- Allergy, hypersensitivity or medical contraindication to either medication.
- Chronic pain requiring opioid pain management or other contraindicated medications.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NYU Langone Healthlead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (4)
Tufts University Health Sciences
Boston, Massachusetts, 02111, United States
Baystate Health
Springfield, Massachusetts, 01199, United States
Middlesex County House of Corrections
New Brunswick, New Jersey, 08902, United States
NYU Langone Health - 180 Madison Ave
New York, New York, 10016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Farabee, PhD
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2023
First Posted
September 25, 2023
Study Start
June 2, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
March 1, 2027
Last Updated
September 10, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to david.farabee@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
All of the de-identified individual participant data collected during the trial will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: david.farabee@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.