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A Usability Assessment of Naloxone by Community Members

NCT03309449 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2023-06-08

Study results available
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Summary

This will be a usability trial to assess administration of naloxone via intramuscular, atomized intranasal, and nasal spray routes by nonmedical community members. Participants will undergo blocked randomization to naloxone kits containing supplies for one of the aforementioned routes and view an instructional video on how to appropriately administer the kit they were assigned. Participants will then have the opportunity to administer the simulated drug to a mannequin designated to simulate the route of administration assigned to the participant. The rate of successful administration will be determined for each route.

Conditions

  • Drug Overdose

Interventions

DEVICE

Syringe and needle

Intramuscular administration of simulated naloxone

DEVICE

Intranasal mucosal atomization device

Intranasal atomizer administration of simulated naloxone

DEVICE

Nasal spray

Nasal spray administration of simulated naloxone

Sponsors & Collaborators

  • State University of New York - Upstate Medical University

    lead OTHER

Principal Investigators

  • William Eggleston, PharmD · State University of New York - Upstate Medical University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2016-09-30
Completion
2017-03-31
FDA Device
Yes

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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 NCT03309449 on ClinicalTrials.gov