drugset / Trial / NCT06441604
Extended-release Buprenorphine as a Novel Low-dose Induction Strategy
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Buprenorphine | Other / unclassified | 16 mg | Other |
| Subject | Buprenorphine | Other / unclassified | 24 mg | Other |
| Subject | Buprenorphine | Other / unclassified | 32 mg | Other |