Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed NA study, sponsored by State University of New York - Upstate Medical University.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Successfully administering the randomly assigned device within 7 minutes and without any critical errors.
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 |
What the finished NCT04025671 record still lists
NCT04025671 is an interventional study that assigns participants to a tested intervention. The registered 208 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 3 interventions - of which Nasal Spray Naloxone is the first listed.
NCT04025671 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04025671's enrollment target sits among peer trials
208 496th of 2000 higher than 1,502 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03465774 · 208 participants
Indwelling Pleural Catheters With or Without Doxycycline in Treating Patients With Malignant Pleural Effusions
- NCT03803332 · 208 participants · NA
A Trial Comparing Interpersonal Therapy to Exposure Therapy for PTSD Due to Military Sexual Trauma (MST) in Male and Female Military Personnel
- NCT04732065 · 208 participants · Phase 1
ONC206 for Treatment of Newly Diagnosed, Recurrent Diffuse Midline Gliomas, and Other Recurrent Malignant CNS Tumors
- NCT05293756 · 208 participants · NA
OPtimizing Technology to Improve Medication Adherence and BP Control (OPTIMA-BP)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI