Reversal of Opioid-induced Respiratory Depression With Opioid Antagonists
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorLeiden University Medical Center
About this trial
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 criteria
Qualifiers
Signed the informed consent form (ICF) and able to comply with the study requirements and restrictions listed therein;
Male and female subjects, age 18 to 70 years, inclusive;
Women of childbearing potential (defined as all women who are not surgically sterile or postmenopausal for at least 1 year prior to informed consent) must have a negative serum pregnancy test prior to enrolment and must agree to use a medically acceptable means of contraception from screening through at least 1 month after the last dose of study drug;
Body Mass Index (BMI) 18 to 30 kg/m2, inclusive;
Disqualifiers
Currently meet the criteria for diagnosis of substance use disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria on any substance;
Any other active medical condition, organ disease or concurrent medication or treatment that may either compromise subject safety or interfere with study endpoints;
Consume, on average, >27 20 units/week of alcohol in men and > 20 13 units/week of alcohol in women (1 unit = 1 glass (250 mL) beer, 125 mL glass of wine or 25 mL of 40% spirit);
Previous or current treatment with opioid agonist, partial agonist, or antagonist treatment within 30 days prior to the first study drug administration;
Trial design
Treatments tested in this trial
- Narcan 40 MG/ML Nasal Spray
- Naloxone Hydrochloride
- Nalmefene HCl injection
Treatment groups
24 Participants
are divided into 4 treatment groupsSponsors and collaborators
Leiden University Medical Center
Lead sponsor
Food and Drug Administration (FDA)
Collaborator
Source ClinicalTrials.gov