Comparing Injectable and Sublingual Buprenorphine Treatments for Adults Using High Potency Synthetic Opioids with Opioid Use Disorder

What this Trial Is About

Researchers are evaluating two forms of buprenorphinesublingual tablets versus a long-acting injectableto treat opioid use disorder in adults who use fentanyl or other strong synthetic opioids. The study aims to compare how often participants use drugs and experience relapse after starting either treatment. It also explores how factors like body fat, weight, fentanyl use before treatment, blood levels of buprenorphine, cravings, and withdrawal symptoms affect treatment outcomes. Participants will begin treatment during a brief overnight hospital stay, where they receive either a single dose of sublingual buprenorphinenaloxone followed by the injectable or standard sublingual buprenorphinenaloxone titration. Blood and urine samples will be collected during the hospital stay and follow-up visits. These visits occur at 1, 2, 3, and 4 weeks after leaving the hospital to monitor drug use, cravings, withdrawal, quality of life, and physical health. Throughout the study, participants will provide samples and attend in-person follow-ups to assess their progress and treatment effects. Researchers will measure the percentage of days participants remain abstinent from opioids and rates of sustained relapse during the 4-week follow-up. They will also evaluate withdrawal severity and dropout rates during the initial inpatient period. The total participation time includes the inpatient stay plus 4 weeks of follow-up visits.

A Clinical Trial Comparing Buprenorphine Formulations for High Potency Synthetic Opioid Use