Overview

Reversal of Opioid-induced Respiratory Depression With Opioid Antagonists

Status:
Not yet recruiting
Trial end date:
2024-05-30
Target enrollment:
Participant gender:
Summary
In this pharmacokinetic/pharmacodynamic modelling study we will determine the ability of intranasal and intramuscular naloxone to reverse opioid (fentanyl and sufentanil)- induced respiratory depression in healthy volunteers and chronic opioid users to develop dosing recommendations in case of opioid-induced respiratory depression from an opioid overdose in clinical practice and in the out-of-hospital overdose.
Phase:
Phase 1
Details
Lead Sponsor:
Leiden University Medical Center
Collaborator:
U.S. Food and Drug Administration (FDA)
Treatments:
Naloxone