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A Usability Assessment of Naloxone by Community Members

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03309449
Recruitment Status : Completed
First Posted : October 13, 2017
Last Update Posted : October 13, 2017
Sponsor:
Information provided by (Responsible Party):
State University of New York - Upstate Medical University

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.

Condition or disease Intervention/treatment Phase
Drug Overdose Device: Syringe and needle Device: Intranasal mucosal atomization device Device: Nasal spray Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Usability Assessment of Intramuscular, Atomized Intranasal, and Nasal Spray Administration of Naloxone by Community Members
Actual Study Start Date : August 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : March 2017

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Arm Intervention/treatment
Intramuscular administration
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
Intramuscular administration of simulated naloxone

Intranasal (Atomizer)
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 atomizer administration of simulated naloxone

Intranasal (Spray)
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
Nasal spray administration of simulated naloxone




Primary Outcome Measures :
  1. Successful administration of naloxone [ Time Frame: 10 minutes ]
    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 (found in detailed description).


Secondary Outcome Measures :
  1. Time to successful administration of naloxone [ Time Frame: 10 minutes ]
    The time required to successfully administer the simulated naloxone will be reported for each group.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy adults at least 18 years of age

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309449


Sponsors and Collaborators
State University of New York - Upstate Medical University
Investigators
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Principal Investigator: William Eggleston, PharmD State University of New York - Upstate Medical University
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Responsible Party: State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT03309449    
Other Study ID Numbers: 922070-1
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Drug Overdose
Substance-Related Disorders
Chemically-Induced Disorders