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NCT05099614
Naloxone Auto-injection in Healthy Volunteers
EARLY_PHASE1 trial testing Naloxone hydrochloride injection solution, SmartDose wearable auto injector and mobile respiratory sensing system in Overdose Antidote in 20 participants. Completed in 5 April 2021.
5 April 2021
Quick facts
| Lead sponsor | University of Washington |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 20 |
| Start date | 10 March 2021 |
| Primary completion | 5 April 2021 |
| Estimated completion | 5 April 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Naloxone hydrochloride injection solution, SmartDose wearable auto injector and mobile respiratory sensing system
Conditions studied
- Overdose Antidote — all drugs for Overdose Antidote →
Sponsor
University of Washington
Who can join
18 and older, any sex, with Overdose Antidote. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Closed-loop wearable naloxone injector system.
Chan J, Iyer V, Wang A, Lyness A, et al · · 2021 · cited 22× · PMID 34811425 · DOI 10.1038/s41598-021-01990-0
Verify or expand the search:
- PubMed search for NCT05099614
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05099614 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Washington
- Last refreshed: 29 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05099614.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing