Overview

Single Dose Crossover Study to Compare the Respiratory Drive After Administration of Belbuca, Oxycodone and Placebo.

Status:
Completed
Trial end date:
2019-10-27
Target enrollment:
Participant gender:
Summary
The purpose of this study is to explore and compare VRH after administration of Belbuca, Oxycodone HCl and Placebo in recreational opioid users. This is a single-center, double -blind, double-dummy , placebo-controlled randomized crossover study in up to 18 men and women self identifying as recreational users. This study will consist of a screening phase, treatment phase (which includes the Naloxone Challenge test) and follow-up visit.
Phase:
Phase 1
Details
Lead Sponsor:
BioDelivery Sciences International
Collaborator:
PRA Health Sciences
Treatments:
Buprenorphine
Oxycodone