Reversal of Opioid-induced Respiratory Depression With Opioid Antagonists in Opioid Naive and Chronic Users under Real-life Conditions

What this Trial Is About

Researchers are studying how different opioid antagonists can reverse breathing problems caused by opioids like fentanyl and sufentanil. This study focuses on both healthy adults and chronic opioid users to understand how intranasal and intravenous naloxone and intravenous nalmefene affect breathing and pupil size. The goal is to develop better dosing recommendations to treat opioid overdoses effectively in hospitals and emergency situations outside the hospital. The study involves two main parts: first, healthy and chronic opioid users receive continuous low-dose infusions of fentanyl or sufentanil to reduce their breathing by 40-60%. During this, participants receive intranasal naloxone spray twice or intravenous naloxone or nalmefene at set intervals. Blood samples and pupil measurements are taken regularly to monitor drug levels and effects. This randomized, open-label crossover study assesses how these drugs reverse opioid effects on breathing and pupil reaction. Participants will undergo medical evaluations and regular monitoring including breathing measurements, blood tests, and pupil size checks. Minute ventilation is the primary measurement to understand respiratory function, while pupil diameter provides additional information on drug effects. The study also monitors side effects such as nausea, dizziness, and respiratory depression. Participation lasts through the infusion and observation periods with frequent assessments to ensure safety and collect detailed data on drug effects and dosing.

Reversal of Opioid-induced Respiratory Depression With Opioid Antagonists