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NCT04025671 · ClinicalTrials.gov registry record · NA
A Usability Assessment of Naloxone Administration by Untrained Community Members
A NA study, sponsored by State University of New York - Upstate Medical University.
- Completed
- Registry status
- NA
- Development phase
- 208
- Enrollment target
NCT04025671 is a NA study that has completed, run by State University of New York - Upstate Medical University. The registered enrollment target is 208 participants.
The verdict
NCT04025671, a NA study, has completed, sponsored by State University of New York - Upstate Medical University.
- COMPLETED
- Registry status
- NA
- Development phase
- 208 participants
- Enrollment target
Study 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 t
Interventions
- DEVICE Nasal Spray Naloxone
- DEVICE Intramuscular Naloxone
- DEVICE Improvised Nasal Atomizer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 208 participants |
| Start Date | 2017-08-23 |
| Est. Completion | 2017-09-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04025671
The ClinicalTrials.gov registry entry for NCT04025671 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 208 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is State University of New York - Upstate Medical University, which has 113 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Nasal Spray Naloxone is the first listed.
NCT04025671 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04025671 about?
NCT04025671 is a clinical study titled "A Usability Assessment of Naloxone Administration by Untrained Community Members". 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 a...
What is the current status of trial NCT04025671?
This trial is currently completed. It is a NA study. The enrollment target is 208 participants. The study started on 2017-08-23. Estimated completion is 2017-09-03.
What interventions are being tested in trial NCT04025671?
The interventions under investigation include: Nasal Spray Naloxone (DEVICE), Intramuscular Naloxone (DEVICE), Improvised Nasal Atomizer (DEVICE).
Who is sponsoring clinical trial NCT04025671?
This trial is sponsored by State University of New York - Upstate Medical University, which has 113 total clinical trials registered on ClinicalTrials.gov.
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