Principal investigator Carlos Tirado, MD, a Texas-based addiction medicine specialist and chief medical officer of research site CARMAhealth Management, has inked a collaborative deal to study an investigational, noninvasive device developed by Dallas-based Spark Biomedical Inc. As the opioid crisis rages on, some liken the patient’s perspective on withdrawal to “the vampire’s view on sunlight.”
CARMAhealth is a Texas-based addiction medicine-focused provider and research center. It is an integrated behavioral health and primary care organization, the Editor of Addiction Professional, Gary Enos, reports. They offer medical support in two treatment facilities found in Austin and South Florida called “Recovery Unplugged.” As touted on their website, they offer an array of substance abuse treatment services.
The Study and Target
It is hoped that data generated from the 40 participant study will lead to Food and Drug Administration (FDA) approval of the “Phoenix,” the Spark Biomedical device—by Q3 2020. The goal of the study, where the Phoenix is worn up to 5 days, is to reduce the physical and emotional symptoms of opioid withdrawal.
The Investigational Device
The Phoenix™ System is a wearable, over-the-ear device that includes a rechargeable battery developed to deliver a mild electrical stimulation to cranial nerve branches with a direct signal to the central nervous system. The device involves no needles. The sponsor suggests that the stimulation possibly can help restore autonomic balance (break down the “fight” or “flight” response) and supporting the production of endorphins that can actually compensate and fill channels that opioids offered. Currently, it is an “unbearable” process for many. The hope is that if this device works as intended, the withdrawal process can become more tolerable.
Spark Biomedical, based in Texas, was formed in 2018 by professionals with experience in the neurostimulation sector. Classified as a medical device company, they seek to develop non-invasive neurostimulation solutions for opioid withdrawal and addiction. In addition to the Phoenix opioid withdrawal study, Spark is conducting a National Institutes of Health-funded study to determine if auricular neurostimulation can assist newborns with neonatal abstinence syndrome (NAS).
Dr. Tirado is board certified in General and Addiction Psychiatry and in Addiction Medicine. He is a recognized thought leader, innovator, mentor and clinical expert in addiction treatment and systems of care. Dr. Tirado spent the first half of his career in academia holding faculty appointments at the University of Pennsylvania and University of Texas Southwestern Medical Center. He subsequently has developed and implemented hospital, facility-based, outpatient addiction treatment services, outpatient chronic pain management, and primary care for addiction programs. His consulting work concentrates on medication therapy and clinical trials, health plans, peer recovery support, expert witness, and medical board review.Source: Addiction Professional