N/A
N=138
A Usability Assessment of Naloxone by Community Members
Drug Overdose
Bottom Line
View on ClinicalTrials.gov: NCT03309449 ↗Enrolled (actual)
138
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Successful Administration of Naloxone — 32; 41; 46 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Syringe and needle (Device); Intranasal mucosal atomization device (Device); Nasal spray (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- State University of New York - Upstate Medical University
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Successful Administration of Naloxone |
32; 41; 46 | — |
| SECONDARY Time to Successful Administration of Naloxone |
99.9; 110.3; 34.3 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03309449). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.