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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 is a Early Phase 1 study that has completed, run by University of Washington. The registered enrollment target is 20 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05099614
The ClinicalTrials.gov registry entry for NCT05099614 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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