A Usability Assessment of Naloxone by Community Members

NCT03309449 | Completed Results FDA Device

• 1 other identifier: 922070-1
• Study Type: interventional
• Target: 138
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Successful Administration of Naloxone

  A successful administration will be defined as administration of the simulated naloxone to the mannequin head or simulated flesh pad within 10 minutes and without any critical errors. Critical errors include: Failure to attach the needle to the syringe, failure to place the device tip into a nostril, failure to remove both caps from the device, failure to remove the cap from the naloxone, failure to depress the device and release the naloxone into the nostril, failure to remove cap from the naloxone, failure to draw up \> 90% (0.9 ml) of the naloxone, failure to attach atomizer to the device, failure to puncture the simulated flesh pad with the needle, failure to attach the naloxone to the device, failure to push the naloxone into the simulated flesh pad, drug leakage before administration, and administration of the total volume in a single nostril.

  10 minutes

Secondary Outcomes (1)

• Time to Successful Administration of Naloxone

  10 minutes

Study Arms (3)

Intramuscular administration

OTHER

Participants in this arm will be provided with the training and supplies to administer intramuscular simulated naloxone using a syringe and needle to a simulated flesh pad on a mannequin.

Device: Syringe and needle

Intranasal (Atomizer)

OTHER

Participants in this arm will be provided with the training and supplies to administer atomized intranasal simulated naloxone to a mannequin via a syringe using an intranasal mucosal atomization device.

Device: Intranasal mucosal atomization device

Intranasal (Spray)

OTHER

Participants in this arm will be provided with the training and supplies to administer an intranasal spray simulated naloxone to a mannequin.

Device: Nasal spray

Interventions

Syringe and needle DEVICE

Intramuscular administration of simulated naloxone

Intramuscular administration

Intranasal mucosal atomization device DEVICE

Intranasal atomizer administration of simulated naloxone

Intranasal (Atomizer)

Nasal spray DEVICE

Nasal spray administration of simulated naloxone

Intranasal (Spray)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy adults at least 18 years of age

You may not qualify if:

• severely visually or hearing impaired (defined as: legally deaf, legally blind, unable to read print size provided on instructional handout, or unable to hear video audio), previous naloxone administration training, not English proficient, previously participated in the trial, or pregnant

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead

MeSH Terms

Conditions

Drug Overdose

Interventions

Syringes; Needles; Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Therapeutics

Results Point of Contact

• Title: William Eggleston
• Organization: SUNY Upstate Medical University

egglestw@upstate.edu

315-464-8906

Study Officials

• William Eggleston, PharmD

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: October 13, 2017
• Study Start: August 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: March 1, 2017
• Last Updated: June 8, 2023
• Results First Posted: November 2, 2021

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share