NCT04995029

Buprenorphine Extended-Release Subcutaneous Injection (RBP-6000) in High-risk Users

A Randomised, Double-Blind Study Comparing 2 Maintenance Dosing Regimens of Buprenorphine Extended-Release Subcutaneous Injection (RBP-6000) in Treatment-Seeking Adult Participants With Opioid Use Disorder and High-risk Opioid Use

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 785 (actual)
• Sponsor: Indivior Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the induction phase of the study is to compare treatment retention of participants following rapid induction or standard of care (SoC) induction onto extended-release buprenorphine. The primary objective of the maintenance phase is to compare the efficacy of 100 mg and 300 mg maintenance doses of extended-release buprenorphine administered every 4 weeks.

Detailed description

This study consists of an open-label induction phase followed by a double-blind maintenance phase. Each phase is designed to test separate objectives and endpoints. In the induction phase participants who use opioids via an injection route and/or use high doses of opioids who are in withdrawal will be randomly assigned in a 2:1 ratio to extended-release buprenorphine rapid induction or SoC induction. The rapid induction arm is designed to initiate extended-release buprenorphine treatment following a single dose of transmucosal (TM) buprenorphine, while the SoC induction arm inducts the participant onto extended-release buprenorphine using a TM buprenorphine-containing product for a minimum of 7 days. All participants will receive the first injection of extended-release buprenorphine on Day 1 and the second injection on Day 8. Participants eligible to continue treatment in the maintenance phase will be randomized at Week 6 prior to Injection 3 in a 1:1 ratio to receive maintenance doses of either 300 mg or 100 mg extended-release buprenorphine every 4 weeks for a total of up to 8 maintenance injections.

Conditions

• Moderate to Severe Opioid-use Disorder

Interventions

Type	Name	Description
DRUG	Transmucosal Buprenorphine	Transmucosal (TM) buprenorphine as selected by the Investigator per local prescribing guidelines, administered either under the tongue (sublingual) or between the gum and cheek (buccal)
DRUG	Extended-release Buprenorphine	Administered by subcutaneous injection

Timeline

• Start date: 2021-10-26
• Primary completion: 2024-06-26
• Completion: 2024-06-26
• First posted: 2021-08-06
• Last updated: 2026-02-06
• Results posted: 2025-09-25

Locations

29 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study