R41DA056276

The Dove device to prevent opioid overdose deaths: an armband that senses overdose and automatically injects naloxone - Abstract / Project Summary

Despite the wide availability of the antidote naloxone, fatal opioid overdoses still occur at a rate of ~50-70,000 / year in the US. The problem is that naloxone requires a bystander to find and diagnose the overdose, find someone who has naloxone, and then properly administer it. Unfortunately, if this does not occur within 5 minutes, the patient will suffer from brain damage, which is often considered the "hidden epidemic" underneath the opioid death epidemic.

Additionally, ~52% of opioid overdose deaths occur when the patient is totally alone, without nearby bystanders around. To solve these problems, here we introduce the Dove device, which is an armband that detects an opioid overdose via pulse oximetry and accelerometry, and then automatically injects an antidote.

Our collaboration between industry and academia has already moved forward the Dove technology significantly: we published a paper showing 76% of persons who use opioids (PWUOS) (N=97) expressed a strong desire for a device like Dove, and showed a strong preference for an armband over many other device designs. We next preliminarily validated the other technical challenges of Dove: we showed our sensor's accuracy was high on healthy volunteers with induced hypoventilation; and our autoinjector injected reproducibly into bench-top models of skin/fat/muscle. Additionally, we validated the market, reimbursement, sales channels, freedom-to-operate, and regulatory path.

In this STTR grant, we will optimize & test the 3 major components of Dove (harness, sensor, and injector): In Aim 1, we will optimize and validate the harness which keeps the device position on the deltoid muscle. We will do this with structured interviews and observations of PWUOS interacting with each of 6 harness prototypes.

In Aim 2, we will test if the Dove sensor can accurately detect hypoxemia in sleeping patients. Overdose events are relatively rare, so to increase the probability of detecting hypoxia using the Dove's pulse oximeter, we will apply 2 Dove pulse-oximeter prototypes (a finger-ring, and one placed on the shoulder skin) to 20 obstructive sleep apnea (OSA) patients already undergoing sleep studies. We will compare the Dove's pulse oximeter and accelerometry traces vs. those of FDA-approved devices.

Finally, in Aim 3, we will optimize the Dove auto-injector to meet the size & shape constraints specified by PWUOS, and to accurately inject into fresh, cadaveric pigs.

Altrumed

NOT APPLICABLE

93.279 - Drug Abuse and Addiction Research Programs

National Institute on Drug Abuse (NIDA) [HHS - NIH]

Philadelphia, Pennsylvania 191462701 United States

Single Zip Code

Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional) (PA-20-272)

Amendment Since initial award the End Date has been extended from 04/30/24 to 04/30/25 and the total obligations have increased 31% from $319,930 to $419,832.