Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
20 participants
INTERVENTIONAL
2021-03-10
2021-04-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Healthy adults
Healthy adults will receive 1.2 mg of naloxone hydrochloride injection solution, administered once via a wearable auto-injector, West Pharma SmartDose Generation I system. The respiratory sensing system under study is used to detect slowed breathing for the purpose of triggering the administration of the naloxone.
Naloxone hydrochloride injection solution, SmartDose wearable auto injector and mobile respiratory sensing system
1.2 mg of naloxone hydrochloride is administered to healthy adults using the SmartDose wearable auto injector and the mobile respiratory sensing system.
Interventions
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Naloxone hydrochloride injection solution, SmartDose wearable auto injector and mobile respiratory sensing system
1.2 mg of naloxone hydrochloride is administered to healthy adults using the SmartDose wearable auto injector and the mobile respiratory sensing system.
Eligibility Criteria
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Inclusion Criteria
* \>18 years
* No allergy to naloxone or ingredients in its formulation
* Ability to read and understand English
* Written informed consent obtained from subject
* Ability to comply with study requirements
Exclusion Criteria
* History of unusual pain sensitivity, lack of sensitivity
* History of chronic myofascial, inflammatory, neuropathic pain
* Chronic use of medication known to interfere with naloxone
* Pregnant women and nursing mothers
* Presence of a condition or abnormality that in the opinion of the Principal Investigator would compromise subject safety or the quality of the data (e.g., persons with liver disease, renal insufficiency/failure)
* Alcohol on the breath
18 Years
ALL
Yes
Sponsors
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U.S. National Science Foundation
FED
University of Washington
OTHER
Responsible Party
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Jacob Sunshine
Associate Professor, School of Medicine
Principal Investigators
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Jacob Sunshine, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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University of Washington
Seattle, Washington, United States
Countries
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Other Identifiers
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1914873
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
STUDY00005944
Identifier Type: -
Identifier Source: org_study_id