Overdose Antidote
Conditions
Brief 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_PRODUCTNaloxone 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.
Sponsors
U.S. National Science Foundation
University of Washington
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy male/female volunteers * \>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 alcohol or substance abuse * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of slowed breathing that triggers the successful actuation of the auto-injector | 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. | Ability of the accelerometer-based system to detect slowed breathing and trigger the successful auto injection of medication |
| Plasma concentration of naloxone in blood samples | Blood sampling at 3 and 8 minutes after the auto injector is triggered | The concentration of naloxone in the plasma is measured by blood at two time points |
Countries
United States
Outcome results
None listed