Comparison of Naloxone Pharmacokinetics

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Opioid-use Disorder

Clinical Trial Details

NCT number	NCT03386591
Study type	Interventional
Source	National Institute on Drug Abuse (NIDA)
Contact
Status	Completed
Phase	Phase 1
Start date	January 3, 2018
Completion date	March 6, 2018

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