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Comparison of multiple doses of intramuscular versus intranasal naloxone for reversal of opioid toxicity

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505338-93-00
Enrollment
22
Registered
2023-08-14
Start date
2023-09-21
Completion date
2024-09-06
Last updated
2023-08-14

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

Conditions

Healthy volunteers

Brief summary

• Number of naloxone administrations

Detailed description

• Number of naloxone administrations, • Timing of minute ventilation, end-tidal PCO2 and plasma concentrations of naloxone, • Plasma concentrations of naloxone and fentanyl, • Pupil diameter and muscle tone

Interventions

DRUGZIMHI™ (naloxone hydrochloride injection) for intramuscular or subcutaneous use
DRUGNARCAN® (naloxone hydrochloride) nasal spray
DRUGoplossing voor injectie

Sponsors

Leiden University Medical Center
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
• Number of naloxone administrations

Secondary

MeasureTime frame
• Number of naloxone administrations, • Timing of minute ventilation, end-tidal PCO2 and plasma concentrations of naloxone, • Plasma concentrations of naloxone and fentanyl, • Pupil diameter and muscle tone

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 5, 2026