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Comparison of Naloxone Pharmacokinetics

NCT03386591 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-03-09

No results posted yet for this study

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

DRUG

Naloxone

Comparing pharmacokinetics of naloxone

DEVICE

Mucosal atomization device and syringe

Injection

DEVICE

Narcan

Nasal Spray

DEVICE

Intramuscular Auto Injector

Intramuscular injection

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    lead NIH

Principal Investigators

  • Debra Kelsh, MD · Vince and Associates Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-03
Primary Completion
2018-02-08
Completion
2018-03-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03386591 on ClinicalTrials.gov