Researchers are developing a novel, implantable device that can sense the effects of a potentially fatal level of ingested opioids and then automatically and immediately deliver a life-saving dose of naloxone.

The closed-loop system senses dangerously low oxygen levels, associated with an opioid overdose, and immediately and automatically delivers naloxone. (Credit: Northwestern)
A peek inside the closed-loop drug-delivery system. (Credit: Northwestern)

The interdisciplinary research team, led by Northwestern University and Washington University at St. Louis, recently received a grant from the National Institutes of Health’s Helping to End Addiction Long-term (NIH HEAL) Initiative to accelerate its research.

The first phase of the program aims to develop and demonstrate the devices in animal models. The second phase, contingent on the first, will advance to the technology into a form suitable for use in humans. The full funding corresponds to $10 million over five years. Engineering development will occur at Northwestern, while in vivo testing will be performed at Washington University.

“Deaths from opioid overdose represent a human health crisis of epic proportions,” says Northwestern’s John A. Rogers, co-principal investigator on the project. “We envision an engineering-oriented approach to this crisis that exploits innovative bio-integrated electronic technologies.”

“When an opioid user goes through treatment or serves time in jail and does not use for several weeks, that person quickly loses the tolerance they have built up over years of opioid use,” says Dr. Robert Gereau, co-principal investigator on the project. “If that person then has a setback and uses again, that individual won’t be able to tolerate the same dose of the drug as before that period of abstinence. Such people are at high risk for overdose death — and even though naloxone is becoming more widely available, there isn’t always someone nearby to recognize the danger and administer the naloxone to rescue that person.”

Rogers is the Louis Simpson and Kimberly Querrey Professor of Materials Science and Engineering, Biomedical Engineering and Neurological Surgery in Northwestern’s McCormick School of Engineering and Feinberg School of Medicine. He also is the director of the Center for Bio-Integrated Electronics.

Gereau is the Dr. Seymour and Rose T. Brown Professor of Anesthesiology at Washington University School of Medicine.

More than 2 million Americans currently live with opioid use disorders and have a high risk of accidental overdose, which can cause severe, permanent lung damage or even death. The current opioid overdose treatment requires administration of an antidote, called naloxone, by a trained emergency responder.

Although highly effective, naloxone administration faces several barriers: Another person must recognize symptoms of an overdose, and then contact emergency medical personnel with access to naloxone and the ability to administer it quickly and correctly. Tragically, overdoses most likely occur when the opioid user is alone or when naloxone delivery is too late.

Rogers’s and Gereau’s device would bypass all these barriers, as an automated form of emergency response and intervention. The complete system, which is about the size of a small USB thumb drive, can be implanted superficially, just beneath the skin, either in the abdomen, lower back or near the collar bone. Patients with a history of opioid use, who are at particularly high risk for overdose, could choose to have the implantation.

“These small, wireless implants support compact, sealed reservoirs filled with naloxone,” Rogers says. “A miniaturized, continuous sensor of tissue oxygenation identifies overdose episodes that lead to dangerously low oxygen supply, thereby automatically triggering the immediate release of a life-saving dose of naloxone — as an autonomous emergency response.”

This article was written by Amanda Morris, Northwestern University. For more information, visit here .