MedTrace Logo

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

NCT03996694 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2021-02-05

Study results available
· View outcomes & findings →

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

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

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • BioDelivery Sciences International

    lead INDUSTRY

Principal Investigators

  • Lynn Webster · PRA Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-23
Primary Completion
2019-10-27
Completion
2019-10-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03996694 on ClinicalTrials.gov