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| ID | Type | Description | Link |
|---|---|---|---|
| 1914873 | Other Grant/Funding Number | NSF |
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| Name | Class |
|---|---|
| U.S. National Science Foundation | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy adults | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naloxone hydrochloride injection solution, SmartDose wearable auto injector and mobile respiratory sensing system | Combination Product | 1.2 mg of naloxone hydrochloride is administered to healthy adults using the SmartDose wearable auto injector and the mobile respiratory sensing system. |
| Measure | Description | Time Frame |
|---|---|---|
| Detection of slowed breathing that triggers the successful actuation of the auto-injector | Ability of the accelerometer-based system to detect slowed breathing and trigger the successful auto injection of medication | The participant breathes to 8 breaths per minute and the breath hold (15 - 30 seconds) triggers the auto-injector. This will take place over 1 -3 minutes. |
| Plasma concentration of naloxone in blood samples | The concentration of naloxone in the plasma is measured by blood at two time points | Blood sampling at 3 and 8 minutes after the auto injector is triggered |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacob Sunshine, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98195 | United States |
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