Risk Stratification of Respiratory Depression with Buprenorphine Buccal Film Versus Oxycodone: Phase 1 Trial Outcomes

Abstract

INTRODUCTION: A phase 1 study (ClinicalTrials.gov, NCT03996694) assessed the effects of buprenorphine buccal film (BBF) and oxycodone on respiratory drive. The risk of respiratory depression was established for BBF and oxycodone using a new risk classification method. Methods: This randomized, double-blind, double-dummy, 6-treatment, 6-period, placebo-controlled crossover study evaluated respiratory drive in healthy, self-identified recreational opioid users via the ventilatory response to hypercapnia by maximum decrease in minute ventilation (primary endpoint) after the administration of BBF (300, 600, and 900 µg), immediate-release oral oxycodone (30 and 60 mg), and placebo.