Moderate to Severe Opioid-use Disorder Clinical Trial
Official title:
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
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.
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. ;