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NCT05099614 · ClinicalTrials.gov registry record · Early Phase 1
Naloxone Auto-injection in Healthy Volunteers
A Early Phase 1 study, sponsored by University of Washington.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
NCT05099614: Completed Early Phase 1 study, sponsored by University of Washington.
NCT05099614 is a Early Phase 1 study that has completed, run by University of Washington. The registered enrollment target is 20 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05099614, a Early Phase 1 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
This study continues the work to develop a mobile breathing monitoring system to detect slowed breathing and overdose events caused by opioid use. This is a single-site feasibility study designed to test the mobile application with a commercially available drug delivery device called the SmartDose by West Pharmaceuticals, Inc. The SmartDose is a wearable self-injection device that can deliver a drug under the skin with a push of a button. Naloxone is a drug used to reverse the effects of opioid drugs in the body. This study will evaluate if the mobile application can wireless trigger the delivery of a small dose of naloxone to a healthy adult volunteer.
Primary Outcome
Ability of the accelerometer-based system to detect slowed breathing and trigger the successful auto injection of medication
Interventions
- COMBINATION_PRODUCT Naloxone hydrochloride injection solution, SmartDose wearable auto injector and mobile respiratory sensing system
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2021-03-10 |
| Est. Completion | 2021-04-05 |
| Phase | Early Phase 1 |
What the finished NCT05099614 record still lists
NCT05099614 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which Naloxone hydrochloride injection solution, SmartDose wearable auto injector and mobile respiratory sensing system is the first listed.
NCT05099614 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05099614 about?
NCT05099614 is a clinical study titled "Naloxone Auto-injection in Healthy Volunteers". This study continues the work to develop a mobile breathing monitoring system to detect slowed breathing and overdose events caused by opioid use. This is a single-site feasibility study designed to test the mobile application with a commercially available drug delivery device called the SmartDose b...
What is the current status of trial NCT05099614?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2021-03-10. Estimated completion is 2021-04-05.
What interventions are being tested in trial NCT05099614?
The interventions under investigation include: Naloxone hydrochloride injection solution, SmartDose wearable auto injector and mobile respiratory sensing system (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05099614?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05099614's enrollment target sits among peer trials
20 1157th of 2000 higher than 709 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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
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