A Usability Assessment of Naloxone by Community Members
|ClinicalTrials.gov Identifier: NCT03309449|
Recruitment Status : Completed
First Posted : October 13, 2017
Last Update Posted : October 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Drug Overdose||Device: Syringe and needle Device: Intranasal mucosal atomization device Device: Nasal spray||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||138 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
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
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
- 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).
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309449
|Principal Investigator:||William Eggleston, PharmD||State University of New York - Upstate Medical University|