Clinical Outcomes From Nalmefene (COINED)
Opioid Overdose
About this trial
This is an interventional treatment trial for Opioid Overdose
Eligibility Criteria
Inclusion Criteria: Presumed or known opioid overdose in community settings. Experiencing clinically significant respiratory depression based on appropriate medical judgement. Patient airway is open and unobstructed at the time of enrollment. (Utilization of oral pharyngeal or nasal pharyngeal airway is allowed.) Pre-hospital naloxone administration is allowed. Exclusion Criteria: Patient age known or estimated to be less than 18 years. Patient has one or more additional documented acute medical, traumatic, toxicologic, or psychiatric conditions that would extend length of treatment or adversely alter the clinical outcome. Cardiac arrest, secondary to opioid intoxication. Arrested, jailed, or imprisoned patients. Inappropriate for the study per judgement of research team.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Nalmefene
Naloxone
Nalmefene hydrochloride (HCl) injection
Naloxone hydrochloride (HCl) injection