Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06408714
Other study ID # UNM24-157
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date July 1, 2024
Est. completion date December 31, 2026

Study information

Verified date May 2024
Source University of New Mexico
Contact Silas Bussman
Phone 505-272-6370
Email sibussman@salud.unm.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare naloxone to nalmefene for the treatment of opioid overdose in adults. The main questions it aims to answer are: - Does nalmefene lower the number of doses of medicine participants need to treat opioid overdose? - When participants are given nalmefene instead of naloxone, do they have fewer complications of opioid overdose such as being admitted to the hospital or having a breathing tube inserted? Researchers will compare nalmefene to naloxone for the treatment of opioid overdose. Nalmefene and naloxone are both approved medicines to treat opioid overdose. Participants who are brought to the emergency department after an opioid overdose will be given a dose of either nalmefene or naloxone if their breathing slows down again after an opioid overdose. Participants will: - Stay in the emergency department for 8 hours after receiving a dose of nalmefene or naloxone. - Receive a phone call 7 days after their emergency department to check on how they are doing. Background information: Naloxone (also known as Narcan) and nalmefene are opioid blocking medicines. When someone overdoses on an opioid, such as heroin or fentanyl, their breathing slows down or stops and they can die. By giving naloxone or nalmefene, the effect of the opioid can be blocked and the person can start breathing again. Naloxone is the most commonly used medicine to reverse an opioid overdose. The effect of naloxone lasts about an hour, and patients may need more than one dose of naloxone to keep them breathing. Sometimes patients overdose, get a dose of naloxone and wake up, and then some time later their breathing slows down again and they need another dose of naloxone. This can happen because the effect of the opioid they took lasts longer than the effect of the naloxone. The effect of nalmefene lasts longer than naloxone, about four hours. If a person gets nalmefene, their opioid may wear off before the nalmefene wears off and they might not need any more doses of a reversal medicine. Both naloxone and nalmefene are approved medicines for treating opioid overdose. Often, when a person overdoses on an opioid, someone gives them naloxone right away and then they are brought to the emergency department. In the emergency department, they are watched for several hours to make sure they don't stop breathing again when their naloxone wears off. If they do stop breathing again, they are given another dose of naloxone. In this study, participants will be given either nalmefene or naloxone if their breathing slows down while they are in the emergency department.


Description:

Read more »
Read more »

Study Design


Intervention

Drug:
Nalmefene Injection
Subjects in this arm will be administered intravenous nalmefene with a dosing scheme of: 0.5 mg Nalmefene IV If an adequate response (increase in RR of at least 5 breaths per minute and minimum respiratory rate of 12 breaths per minute or reduction in ETCO2 to 40 mm Hg) is not attained after 2 minutes, an additional 1.0 mg nalmefene will be administered. If an adequate response is not attained after an additional 2 minutes of observation, naloxone may be administered as a rescue agent at the treating physician's discretion.
Naloxone Injection
Subjects in this arm will be administered intravenous naloxone with a dosing scheme of: 0.4 mg Naloxone IV If an adequate response (increase in RR of at least 5 breaths per minute and minimum respiratory rate of 12 breaths per minute or reduction in ETCO2 to 40 mm Hg) is not attained after 2 minutes, an additional 0.4 mg of naloxone will be administered. If an adequate response is not attained after an additional 2 minutes of observation, naloxone may be administered as a rescue agent at the treating physician's discretion.

Locations

Country Name City State
United States University of New Mexico Health Sciences Center Albuquerque New Mexico

Sponsors (1)

Lead Sponsor Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

References & Publications (3)

McLaughlin SA, Crandall CS, McKinney PE. Octreotide: an antidote for sulfonylurea-induced hypoglycemia. Ann Emerg Med. 2000 Aug;36(2):133-138. doi: 10.1067/mem.2000.108183. — View Citation

Newcombe RG. Interval estimation for the difference between independent proportions: comparison of eleven methods. Stat Med. 1998 Apr 30;17(8):873-90. doi: 10.1002/(sici)1097-0258(19980430)17:83.0.co;2-i. Erratum In: Stat Med 1999 May 30;18(10):1293. — View Citation

Wei LJ, Lin DY, Weissfeld L. Regression analysis of multivariate incomplete failure time data by modeling marginal distributions. J Am Stat Assoc. 1989;84:1065-1073.

Outcome

Type Measure Description Time frame Safety issue
Primary Recurrent respiratory depression Recurrent respiratory depression requiring repeat treatment with an opioid antagonist. Respiratory depression is defined as a respiratory rate (RR) <8 breaths per minute or end-tidal CO2 (ETCO2)> 50 mm Hg. Within 8 hours of intervention
Secondary Precipitated withdrawal • Proportion of subjects experiencing precipitated withdrawal (Clinical Opioid Withdrawal Scale greater than 5 within 20 minutes) after treatment with an opioid antagonist. The Clinical Opioid Withdrawal Scale, or COWS, ranges from 0 to 48, with a higher score signifying worse withdrawal. Within 8 hours of intervention
Secondary Serious adverse event • Proportion of subjects experiencing a serious adverse event (likely admission to the hospital, typically for pulmonary edema, methadone overdose, or co-ingestions requiring extended observation). Within 8 hours of intervention
See also
  Status Clinical Trial Phase
Completed NCT04372238 - The Rhode Island Prescription and Illicit Drug Study N/A
Recruiting NCT03924505 - Preventing Opioid Overdose Mortality in the United States N/A
Completed NCT05093309 - Preventing Opioid Overdose Deaths by Empowering Pharmacists to Dispense Naloxone N/A
Completed NCT05219669 - Pharmacokinetic Evaluation of Intranasal Nalmefene Using Three Dosing Regimens Phase 1
Completed NCT04317053 - Multi-Center Randomized Controlled Trial of Relay- NYC's Nonfatal Overdose Response Program Phase 3
Not yet recruiting NCT06466005 - UnityPhilly Response App for Overdose Reversal
Recruiting NCT04815590 - Extended-release Injectable Buprenorphine for Individuals at High Risk of Overdose
Active, not recruiting NCT05096429 - Preventing Overdose Using Information and Data From the Environment N/A
Suspended NCT05114460 - Vaped Marijuana to Attenuate Naloxone-Precipitated Withdrawal Phase 2
Recruiting NCT06238128 - Opioid Rapid Response System: Naloxone Training in Communities N/A
Completed NCT02662153 - Incidence and Predictors of Opioid Overdose and Death Among Long-Term Users of Opioid Analgesics
Active, not recruiting NCT05944133 - Health Insurance Instability and Mortality Among Patients Receiving Bup Tx for OUD
Completed NCT05377255 - Pharmacokinetics (PK) and Safety of Multiple Doses of Intranasal Naloxone in Healthy Adults Phase 1
Recruiting NCT05877118 - Improving Availability of Intranasal Naloxone N/A
Recruiting NCT05072249 - European Cohort Study of the Effectiveness of Take Home Naloxone
Withdrawn NCT05808881 - Clinical Outcomes From Nalmefene Phase 4
Not yet recruiting NCT01622504 - Naloxone Nasal Spray Pharmacokinetic Study Phase 1
Not yet recruiting NCT06429436 - Vending Machine Naloxone Distribution for Your Community (VENDY) Phase 4
Completed NCT05506267 - Development of a Tracheal Sound Sensor
Completed NCT02535494 - Risks and Benefits of Naloxone Prescribing N/A