Clinical Trial

Reversal of Opioid-induced Respiratory Depression With Opioid Antagonists

Study acronym: ROAR
Terminated Phase 1
View on ClinicalTrials.gov →
Why the trial stopped
Recruitment of chronic opioid users was substantially lower than anticipated despite extensive recruitment efforts; the study was therefore closed before reaching the planned sample size.
Summary
n this pharmacokinetic/pharmacodynamic modelling study we will determine the ability of intranasal and intravenous naloxone and intravenous nalmefene 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.
Protocol Amendment History 5 changes
critical Trial terminated 2026-07-30
critical Trial terminated: Recruitment of chronic opioid users was substantially lower than anticipated despite extensive recruitment efforts; the... 2026-07-30
notable Enrollment increased: 24 -> 58 participants 2026-07-30
notable Primary completion moved earlier: 2026-08-01 -> 2026-03-23 2026-07-30
minor Completion moved earlier: 2026-10-01 -> 2026-03-23 2026-07-30
Trial Details
NCT Number NCT05338632
Lead Sponsor Leiden University Medical Center
Collaborators: Food and Drug Administration (FDA)
Conditions Opioid Induced Respiratory Depression, Chronic Opioid Use
Enrollment 58 participants
Start Date 2022-06-24
Primary Completion 2026-03-23 (estimated)
Study Completion 2026-03-23 (estimated)
Updated on ClinicalTrials.gov 2026-07-29