NCT03996694

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

A Randomized, Double-Blind, Double Dummy, 6-Period, Placebo-Controlled, Crossover Study to Explore and Compare the Ventilatory Response to Hypercapnia (VRH), of Belbuca, Oxycodone Hydrochloride (HCl) and Placebo in Recreational Opioid Users

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: BioDelivery Sciences International · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Respiratory Depression

Interventions

Type	Name	Description
DRUG	Belbuca 300 µg	Belbuca 300 µg buccal film
DRUG	Belbuca 600 µg	Belbuca 600 µg buccal film
DRUG	Belbuca 900 µg	Belbuca 900 µg buccal film
DRUG	Oxycodone 30 mg	Oxycodone 30 mg capsule
DRUG	Oxycodone 60 mg	Oxycodone 60 mg capsule
DRUG	Placebo	placebo buccal film and oral placebo

Timeline

• Start date: 2019-07-23
• Primary completion: 2019-10-27
• Completion: 2019-10-27
• First posted: 2019-06-25
• Last updated: 2021-02-05
• Results posted: 2021-02-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study