(ROAR) Reversal of opioid-induced respiratory depression with opioid antagonists - a pharmacokinetic pharmacodynamic modeling study in opioid naïve individuals and chronic opioid users under real-life conditions

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518041-16-00

Enrollment

Registered

2024-11-15

Start date

2022-06-15

Completion date

Unknown

Last updated

2024-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

healthy volunteers, opioid use disorder

Brief summary

Our main study measurement is minute ventilation. Together with the plasma concentration of the opioid and naloxone/nalmefene), ventilation is inputted in the PKPD model to get meaningful model parameters such as C50 and t½ke0, measures of potency and the speed of onset/offset of effect, respectively.

Interventions

DRUGFentanyl hameln 50 microgram/ml

DRUGoplossing voor injectie

DRUGNarcan Nasal Spray

DRUGSufentanil Eurocept 5 microgram/ml

DRUGZofran 4 Injectie

DRUGNaloxon HCl-hameln 0

DRUG4 mg/ml

DRUGoplossing voor injectie/infusie

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Our main study measurement is minute ventilation. Together with the plasma concentration of the opioid and naloxone/nalmefene), ventilation is inputted in the PKPD model to get meaningful model parameters such as C50 and t½ke0, measures of potency and the speed of onset/offset of effect, respectively.	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026