In this first episode of a two-part series, Host Daniel Litwin is joined by guest Dr. Carols Tirado MD, MPH of CARMAhealth to explore Spark Biomedical’s Adult Opioid Withdrawal Clinical Trial. As the clinical trial’s principal investigator, Dr. Tirado provides insight into the study results that lead to FDA clearance of Spark Biomedical’s Sparrow Therapy System – wearable neurostimulation for opioid withdrawal relief.

Neurostimulation for opioid withdrawal may seem like the future, but this approach to withdrawal treatment is far from new. Actually, non-invasive neurostimulation has existed for decades, with early studies dating as far back as 1947.

• Electrosleep device developed in USSR, 1947
• Electrosleep for CET to aid in meth detox, U of Chi, 1978
• First RCT double-blind study on CET for heroin withdrawals, France, 1987
• 2018 study on percutaneous auricular neurostimulation for opioid withdrawal
• 2020 Review Article on auricular neural stimulation for opioid detox

The devices used in these early treatments were far from user friendly or portable. But the rough-and-ready predicate devices and the studies in which they were used formed the basis for Spark and CARMAhealth in their most recent round of research.

Dr Tirado noted, “One of the things that the Sparrow has done, it has leapfrogged invasive technology to creating a purely wearable and unobtrusive device.”

Before a new device can enter the market to help, it must receive FDA approval. And, as Dr. Tirado notes, the rigor required to pass muster through an FDA process is the best indicator available to judge the safety and effectiveness of any medical treatment. With that in mind, Dr. Tirado said the goal was to design a trial with the appropriate randomization and blinding to demonstrate treatment effect, treatment safety, and get to a place where the product was ready to start helping patients.

Host: Daniel J. Litwin

Guest: Dr. Carlos Tirado, MD, MPH