A Usability Assessment of Naloxone Administration by Untrained Community Members

NCT04025671 | Completed FDA Device

• 1 other identifier: 1098030
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a randomized, open-label, usability assessment of intramuscular, intranasal, and nasal spray administration of naloxone using two different instruction sets by laypersons.

• Design: Single site, open-label, randomized usability assessment of intramuscular, intranasal, and nasal spray administration of simulated naloxone. A convenience sample of participants will consent to volunteer in the study at a public venue. Participants will provide verbal consent and will be randomly assigned a simulated naloxone kit containing either intramuscular, intranasal, or nasal spray administration materials with either standard or study team designed instructions for use. Participants will enter a use scenario station and be asked to assemble and administer the simulated naloxone kit to a mannequin (intranasal and nasal spray) or simulated flesh pad (intramuscular). The participant will be instructed to start and will be timed until the simulated naloxone has been successfully administered or 7 minutes has elapsed. The participant will be observed by one trained investigator who will assess for successful administration of the simulated naloxone and critical errors. The environment will contain distractors.Once the participant has successfully administered simulated naloxone or 7 minutes elapses the timer will be stopped. Successful administration of simulated naloxone will be defined as administration of the agent without any critical errors occurring (defined below). Data collected will include demographics (defined below), successful administration of simulated naloxone, time to successful administration of simulated naloxone, and Likert-item data assessing the ease of use of the device and instructions.
• Participants: adults (18 years of age and older) at a public venue will be asked to volunteer. Participants with severe visual or hearing impairment (defined as: legally deaf, legally blind, unable to read print size provided on instructional handout, or unable to hear video audio), that have previous naloxone administration training, that are not English proficient, that are pregnant, or that have previously participated in the trial will be excluded.
• Kits:
• Intranasal: simulated naloxone vial, bristoject, administration instructions (standard or study team designed)
• Intramuscular: sterile single use needle, sterile single use 3 mL syringe, simulated naloxone vial, administration instructions (standard or study team designed)
• Nasal spray: simulated naloxone spray, administration instructions (standard or study team designed)
• Objectives:
• Primary: successful administration of simulated naloxone in the time allowed. A successful administration will be defined as administration of the simulated naloxone to the mannequin head of simulated flesh pad within 7 minutes and without any critical errors (defined below).
• Secondary: time required to successfully administer the simulated naloxone and Likert-item assessment of ease of use of both the device and instructions.
• Data and Analysis:
• The usability trial will be conducted using a convenience sample so no power analysis will be conducted or minimum sample size defined
• Demographics: age, gender, handedness, level of education, and presence or absence of opioid at risk contacts.
• Data: successful administration, time to administration, and Likert-item assessment of both the device and instructions. Failure to administer the medication due to a critical use error will be recorded and the specific error reported for all participants.
• Critical Errors:
• Intranasal: failure to remove both yellow caps from bristoject, failure to remove cap from simulated naloxone, failure to attach atomizer, failure to attach simulated naloxone, drug leak prior to administration, administration in only one nostril, and failure to administer within 7 minutes.
• Intramuscular: failure to attach the needle to the syringe, failure to remove cap from simulated naloxone, failure to draw up \>90% (0.9 mL) of the simulated naloxone, failure to puncture simulated flesh pad with needle, failure to push entire volume of fluid in the syringe into the simulated flesh pad, and failure to administer within 7 minutes.
• Intranasal: failure to place the tip of the device into one nostril, failure to depress the device and release the simulated naloxone, failure to administer within 7 minutes.

Conditions

Harm Reduction; Opioid-use Disorder; Naloxone

Keywords

naloxone; opioid use disorder; harm reduction

Outcome Measures

Primary Outcomes (1)

• Percentage of participants who successfully administer the naloxone device

  Successfully administering the randomly assigned device within 7 minutes and without any critical errors.

  7 minutes

Secondary Outcomes (2)

• Time needed to successfully administer the naloxone device

  7 minutes

• Ease of use of the naloxone device according to each participant

  10 minutes

Study Arms (3)

Nasal Spray Naloxone

EXPERIMENTAL

This arm will be randomized to administer a nasal spray naloxone device in a simulated overdose setting.

Device: Nasal Spray Naloxone

Intramuscular

ACTIVE COMPARATOR

This arm will be randomized to administer a intramuscular naloxone device in a simulated overdose setting.

Device: Intramuscular Naloxone

Improvised Nasal Atomizer

ACTIVE COMPARATOR

This arm will be randomized to administer an improvised nasal atomizer naloxone device in a simulated overdose setting.

Device: Improvised Nasal Atomizer

Interventions

Nasal Spray Naloxone DEVICE

Nasal spray naloxone device.

Also known as: Narcan Nasal Spray

Nasal Spray Naloxone

Intramuscular Naloxone DEVICE

A vial of simulated naloxone and syringe with attached needle.

Intramuscular

Improvised Nasal Atomizer DEVICE

A naloxone bristoject dose and nasal atomizer device.

Improvised Nasal Atomizer

Eligibility Criteria

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

You may qualify if:

• years of age
• Able to provide verbal consent

You may not qualify if:

• less than 18 years of age
• pregnant
• had previous experience with naloxone administration or naloxone training

Sponsors & Collaborators

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

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

MeSH Terms

Conditions

Harm Reduction; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Behavior; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

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, 2019
• First Posted: July 19, 2019
• Study Start: August 23, 2017
• Primary Completion: September 3, 2017
• Study Completion: September 3, 2017
• Last Updated: July 19, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)