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

Status Not yet recruiting

Clinical Trial 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 DSM-5 diagnosis of OUD (n=30) will be admitted to an inpatient unit to complete study procedures over the course of 5 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.

Clinical Trial Description

The approach is to conduct a single ascending dose trial in a controlled human laboratory setting with individuals with a DSM-5 diagnosis of OUD (n=30) actively using illicit fentanyl. After obtaining informed consent and establishing eligibility, 10 participants will be scheduled for an inpatient visit lasting 5 days-4 nights and receive XR-BUP when not yet experiencing any opioid withdrawal. Participants will receive fentanyl to prevent the emergence of withdrawal, and on the following morning, receive XR-BUP 16mg in single-blind fashion. If at least 90% successfully complete induction (success defined as experiencing no precipitated withdrawal) with the 16mg dose, then we will proceed with 10 more participants to receive the 24mg dose. If at least 90% successfully complete induction the 24mg dose, then we will proceed with 10 more participants to the 32mg dose. Timed blood samples will be collected in heparinized Vacutainer tubes via a catheter in the antecubital vein at baseline, and at 0.5, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours after the XR-BUP injection. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06441604
Study type	Interventional
Source	Brigham and Women's Hospital
Contact	Joji Suzuki
Phone	6177325752
Email	jsuzuki2@bwh.harvard.edu
Status	Not yet recruiting
Phase	Phase 2
Start date	September 2024
Completion date	July 2026

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