The United States is experiencing an epidemic of opioid use, which has been declared as a national emergency. During an overdose, the respiratory centers in the brain are suppressed. This leads to dangerous lowering of blood oxygen levels, loss of consciousness, and eventually respiratory arrest and death. There are many initiatives to reduce the death rate from opioid overdosing including providing naloxone, a medication that can rapidly counteract and reverse the effects of opioids, to known drug users, their caregivers, and first responders. Naloxone can be administered via intravenous infusion, intramuscular injection, or nasal spray during an overdose. However, rescuers are often not present at the time of overdose. The National Institute of Drug Abuse has identified the need for technologies to address the opioid crisis including interventions against respiratory depression and has released a specific request for SBIR applications to address this critical need. In response, BioSensics, in collaboration with Baylor College of Medicine (BCM), proposes to develop a wearable system for detection of respiratory arrest due to opioid overdose and automatic delivery of naloxone. The key components of the technology are 1) a wrist-worn device that detects respiratory arrest based on measures of blood oxygen levels, respiration rate, and heart rate; 2) a medication delivery device affixed to the thigh using biocompatible adhesive patches that automatically delivers naloxone intramuscularly when respiratory arrest is detected, and 3) a companion iOS/Android app that will be installed on the user's smartphone to contact an emergency call center with the user's GPS location when the system is triggered.
The Specific Aims of this Phase I SBIR application have been designed to demonstrate the feasibility of naloxone delivery via a wearable patch, validate the physiological measures obtained from the connected wrist-worn wearable sensor, and evaluate technology acceptance from key stakeholders. These are the most appropriate aspects of the system to focus on in Phase I because BioSensics has already demonstrated the capability to build the other components of the system. For example, BioSensics has developed a medical alert senor and companion smartphone app; and has already completed technology and business services integration with a national emergency response call center. The significance of this project cannot be understated. On April 5, 2018, U.S. Surgeon General Jerome M. Adams, M.D., M.P.H., issued a statement urging broader distribution of naloxone into the community. Many other public health agencies including the Centers for Disease Control and the World Health Organization have echoed this sentiment. The use of wearable technology to identify opioid induced respiratory arrest in the field and automatically deliver a life-saving dose of naloxone could save thousands of lives. The combination of these technologies (i.e., wrist-worn blood oxygen monitoring coupled with an intramuscular auto-injector of naloxone) has never been proposed and represents a unique solution to the opioid overdose epidemic.

Public Health Relevance

Naloxone can rapidly reverse the effects of opioids and save the life of a person who is experiencing respiratory arrest due to overdose from narcotics. Unfortunately, bystanders with naloxone are not always present at the time of overdose. We proposed to develop a wearable device that detects respiratory arrest due to overdose and automatically delivers naloxone to save the life of a person who is overdosing from narcotics.

National Institute of Health (NIH)
National Institute on Drug Abuse (NIDA)
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
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Special Emphasis Panel (ZDA1)
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Angelone, Leonardo Maria
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Biosensics, LLC
United States
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