drugset / Trial / NCT06441604

Extended-release Buprenorphine as a Novel Low-dose Induction Strategy

NCT06441604

Phase 2 Active not recruiting 8 enrolled Brigham and Women's Hospital University of Utah · collab
Non-randomizedSequentialSingle-blindOther

Summary

This is a clinical trial to characterize the safety and pharmacokinetics of using extended-release buprenorphine (XR-BUP) as a novel low-dose buprenorphine induction strategy. Individuals with a diagnosis of Opioid Use Disorder (OUD) (n=30) will be admitted to an inpatient unit to complete study procedures over the course of 3 days. Participants will receive fentanyl to prevent the emergence of withdrawal. Each participant will then receive a single injection of XR-BUP after which study staff will monitor for any precipitated withdrawal.

Timeline

Start
2025-10-27
Primary completion
2026-06-11
Completion
2027-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Buprenorphine Other / unclassified 16 mg Other
Subject Buprenorphine Other / unclassified 24 mg Other
Subject Buprenorphine Other / unclassified 32 mg Other