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Extended-release Buprenorphine as a Novel Low-dose Induction Strategy
Sponsor: Brigham and Women's Hospital
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-10-27
Completion Date
2026-07-31
Last Updated
2026-03-25
Healthy Volunteers
No
Conditions
Interventions
Extended-release Buprenorphine
The study is a single-blind, fixed-order, dose-escalation designed trial in an inpatient setting with individuals with a DSM-5 diagnosis of OUD (n=30). The first 10 participants will receive XR-BUP 16mg in single-blind fashion. We will then proceed with 10 more participants to the 24mg dose, and finally proceed with 10 more participants to the 32mg dose. All participants will receive fentanyl to prevent withdrawal symptoms. (Figure 2). Symptomatic treatments will be provided at any sign of worsening withdrawal including evidence of precipitated withdrawal.
Locations (1)
Brigham and Women's Hospital
Boston, Massachusetts, United States