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Assessing Optimal XRB Initiation Points in Jail

StatusRecruiting
PhasePhase 4
Started2025-06-02
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 75% 200 → 50 participants
See other at-risk trials from NYU Langone Health

Amendment history

2026-08-05
Study Status, Study Design v8
Enrollment reduced: 200 → 50 participants
2025-09-08
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v7
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-05-31→confirmed 2025-06-02
Study sitesdetails revised at 4 of 4 sites
2025-04-21
Study Status v6
Primary completion date2026-06-01→2026-12-01
Completion date2026-10-01→2027-03-01
Start date2024-11-29→2025-05-31
2024-09-12
Study Status v5
Primary completion date2026-02-01→2026-06-01
Completion date2026-06-01→2026-10-01
Start date2024-07-29→2024-11-29
2024-06-27
Study Status v4
Primary completion date2025-10-01→2026-02-01
Completion date2026-01-01→2026-06-01
Start date2024-03-29→2024-07-29
Show 3 earlier versions
2024-04-04
Study Status, Contacts/Locations v3
Study sites2→4
2024-03-28
Study Status, Contacts/Locations v2
Study sites1→2
2024-02-21
Study Status v1
Start date2024-01-05→2024-03-29
2023-09-18
Original filing
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 Details
NCT Number NCT06051890
Lead Sponsor NYU Langone Health
Collaborators: National Institute on Drug Abuse (NIDA)
Conditions Opioid Use Disorder
Enrollment 50 participants
Start Date 2025-06-02
Primary Completion 2026-12-01 (estimated)
Study Completion 2027-03-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-07