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Reversal of Opioid-induced Respiratory Depression With Opioid Antagonists

NCT05338632 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-01-31

No results posted yet for this study

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.

Conditions

  • Opioid Induced Respiratory Depression
  • Chronic Opioid Use

Interventions

DRUG

Narcan 40 MG/ML Nasal Spray

naloxone 4mg/0.1 mL intranasal spray, up to 4 doses intranasally, followed by 1ml 0.4 mg/ml naloxone hydrochloride intravenously

DRUG

Naloxone Hydrochloride

Naloxone 0.4mg/mL

DRUG

Nalmefene HCl injection

Nalmefene 1 ng/mL

Sponsors & Collaborators

  • U.S. Food and Drug Administration (FDA)

    collaborator UNKNOWN

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • Rutger van der Schrier, MD · LUMC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2022-06-24
Primary Completion
2026-08-01
Completion
2026-10-01
FDA Drug
Yes

Countries

  • Netherlands

Study Locations

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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 NCT05338632 on ClinicalTrials.gov