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
Leiden University Medical Center
24 participants
Jun 24, 2022
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
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Interventions
naloxone 4mg/0.1 mL intranasal spray, up to 4 doses intranasally, followed by 1ml 0.4 mg/ml naloxone hydrochloride intravenously
Naloxone 0.4mg/mL
Nalmefene 1 ng/mL
Locations(1)
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NCT05338632