Clinical Outcomes From Nalmefene

• Status: Not yet recruiting
• Trial end date: 2024-07-26
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the effectiveness of nalmefene relative to naloxone for the reversal of opioid intoxication in emergency department (ED) settings.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Purdue Pharma LP
• Treatments: Nalmefene; Naloxone

Criteria

Inclusion Criteria:

1. Presumed or known opioid overdose in community settings.

2. Experiencing clinically significant respiratory depression based on appropriate medical judgement.

3. Patient airway is open and unobstructed at the time of enrollment. (Utilization of oral pharyngeal or nasal pharyngeal airway is allowed.)

4. Pre-hospital naloxone administration is allowed.

Exclusion Criteria:

1. Patient age known or estimated to be less than 18 years.

2. 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.

3. Cardiac arrest, secondary to opioid intoxication.

4. Arrested, jailed, or imprisoned patients.

5. Inappropriate for the study per judgement of research team.