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Opioid Reversal Agent

Nalmefene vs Naloxone for Opioid Overdose

Phase 3
Recruiting
Led By Caitlin Bonney, MD
Research Sponsored by University of New Mexico
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults (age ≥ 18 years) presenting to the UNM ED after a suspected acute opioid overdose event requiring at least one dose of naloxone.
Be older than 18 years old
Must not have
No working phone number for follow-up contact
Buprenorphine administration during the ED visit prior to enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 8 hours of intervention
Awards & highlights

Summary

This trial aims to compare two medications, naloxone and nalmefene, for the treatment of opioid overdose in adults. The main questions researchers want to answer are whether nalmefene requires

Who is the study for?
Adults who have experienced an opioid overdose and are brought to the emergency department can participate. They must stay for observation for 8 hours after treatment and be available for a follow-up call after 7 days.
What is being tested?
The trial is testing if nalmefene, which lasts longer than naloxone, reduces the need for multiple doses in treating opioid overdoses. It also examines whether nalmefene leads to fewer complications like hospital admission or intubation compared to naloxone.
What are the potential side effects?
Nalmefene and naloxone may cause withdrawal symptoms in patients with opioid dependence, including nausea, vomiting, sweating, agitation, increased heart rate and blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am an adult who received naloxone for an opioid overdose.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have a working phone number for follow-ups.
Select...
I received buprenorphine in the emergency department before joining.
Select...
I am under 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 8 hours of intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 8 hours of intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Recurrent respiratory depression
Secondary study objectives
Precipitated withdrawal
Serious adverse event

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: NalmefeneExperimental Treatment1 Intervention
Nalmefene Rescue Study Arm Treatment: Subjects will receive study drug if they exhibit respiratory depression (defined as respiratory rate less than 8 breaths per minute and/or end-tidal carbon dioxide measurement of greater than 50 mm Hg) lasting for longer than 10 seconds. Respiratory support with bag-valve mask and/or supplemental oxygen will be provided while the study drug is being prepared. Nalmefene will be administered as per intervention description.
Group II: NaloxoneActive Control1 Intervention
Naloxone Rescue Arm Treatment: Subjects will receive study drug if they exhibit respiratory depression (defined as respiratory rate less than 8 breaths per minute and/or end-tidal carbon dioxide measurement of greater than 50 mm Hg) lasting for longer than 10 seconds. Respiratory support with bag-valve mask and/or supplemental oxygen will be provided while the study drug is being prepared. Naloxone will be administered as per intervention description.

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Who is running the clinical trial?

University of New MexicoLead Sponsor
383 Previous Clinical Trials
3,523,120 Total Patients Enrolled
Caitlin Bonney, MDPrincipal InvestigatorUniversity of New Mexico Health Sciences Center
~49 spots leftby Oct 2026
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