RecruitingPhase 1NCT05338632

Reversal of Opioid-induced Respiratory Depression With Opioid Antagonists

Reversal of Opioid-induced Respiratory Depression With Opioid Antagonists - a Study in Opioid naïve Individuals and Chronic Opioid Users Under Real-life Conditions


Sponsor

Leiden University Medical Center

Enrollment

24 participants

Start Date

Jun 24, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug that reverses opioid effects (an opioid antagonist) can safely and quickly reverse breathing problems caused by opioid use, to help address the opioid overdose crisis. **You may be eligible if...** - You are a healthy volunteer between 18 and 70 years old - Your body mass index (BMI) is between 18 and 30 - You are in good general health with no significant medical conditions - Women of childbearing age must test negative for pregnancy and agree to use contraception **You may NOT be eligible if...** - You have significant health conditions (heart, liver, kidney, lung problems) - You are pregnant or breastfeeding - You have a history of opioid dependence or substance use disorder - You are taking medications that could interfere with the study drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGNarcan 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

DRUGNaloxone Hydrochloride

Naloxone 0.4mg/mL

DRUGNalmefene HCl injection

Nalmefene 1 ng/mL


Locations(1)

Leiden University Medical Center

Leiden, South Holland, Netherlands

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05338632


Related Trials