NCT03386591

Comparison of Naloxone Pharmacokinetics

Comparison of Naloxone Pharmacokinetics Using Marketed Naloxone Devices

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: National Institute on Drug Abuse (NIDA) · NIH
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Intranasal (IN) naloxone administration is an effective alternative to intravenous (IV) or intramuscular (IM) naloxone by emergency medical services for opioid overdoses and has been used successfully for this purpose as reported in clinical observational studies and a randomized controlled trial. Most of the published clinical studies concerning IN administration used an improvised kit of 2 mg naloxone/2 mL saline and a mucosal atomizer device (MAD), which is not FDA-approved for this indication. Pharmacokinetic (PK) data using these kits is not available in the published literature. This study is designed to determine the PK of naloxone following one and two IN administrations using the improvised kits compared to 2 and 4 mg delivered IN using the FDA-approved Narcan nasal spray device and 2 mg administered IM using the Evzio autoinjector.

Conditions

• Opioid-use Disorder

Interventions

Type	Name	Description
DRUG	Naloxone	Comparing pharmacokinetics of naloxone
DEVICE	Mucosal atomization device and syringe	Injection
DEVICE	Narcan	Nasal Spray
DEVICE	Intramuscular Auto Injector	Intramuscular injection

Timeline

• Start date: 2018-01-03
• Primary completion: 2018-02-08
• Completion: 2018-03-06
• First posted: 2017-12-29
• Last updated: 2018-03-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study