CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 19 enrolled
Drug / intervention
Belbuca 300 µg +5 moredrug
Likely dose
Belbuca 300 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03996694
NCT03996694Phase 1Completed
CompareCT.gov

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

BioDelivery Sciences International·interventional·Posted Jun 25, 2019·Updated Feb 5, 2021

In Brief

A Phase 1 clinical trial evaluating Belbuca 300 µg, Belbuca 600 µg, and 4 other interventions for Respiratory Depression. Completed, enrolled 19 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Depression
CountriesUnited States
CollaboratorsPRA Health Sciences

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedJun 25, 2019
Enrollment StartJul 23, 2019
Primary CompletionOct 27, 2019
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 7.0 years ago

Interventions

Belbuca 300 µgdrug

Belbuca 300 µg buccal film

Belbuca 600 µgdrug

Belbuca 600 µg buccal film

Belbuca 900 µgdrug

Belbuca 900 µg buccal film

Oxycodone 30 mgdrug

Oxycodone 30 mg capsule

Oxycodone 60 mgdrug

Oxycodone 60 mg capsule

Placebodrug

placebo buccal film and oral placebo