Spark Biomedical announced open patient enrollment in their clinical trial to validate the company's auricular neurostimulation device for opioid withdrawal relief — currently named "Phoenix." Spark is partnering with CARMAhealth a collaborative primary care and psychiatric outpatient practice with a specialty focus on addiction medicine and Recovery Unplugged. Patients with opioid use disorder (OUD) will enroll in the trial at two Recovery Unplugged locations in Austin, Texas, and Lake Worth, Florida.
The prospective, double-blind, randomized control trial aims to demonstrate that the Spark "Phoenix" device can aid in the opioid detoxification process by allowing OUD patients to get through withdrawal safely and comfortably. In early 2019, Spark completed a proof-of-concept study demonstrating that auricular neurostimulation can significantly reduce withdrawal symptoms in active OUD patients, as represented by the Clinical Opiate Withdrawal Scale (COWS).
The "Phoenix" clinical study is overseen by Principal Investigator Dr. Carlos Tirado, MD, MPH, Chief Medical Officer of CARMAhealth Management. Dr. Tirado is Board Certified in General and Addiction Medicine, President of the Texas Society of Addiction Medicine, and is a recognized thought leader, innovator, mentor and clinical expert in addiction treatment and systems of care.
Targeted clinical trial patients include those with current opioid use disorder wanting to undergo withdrawal without the use of opioid-based medication. Patients who need to receive care and are interested can learn more about the study by visiting www.phoenix-study.com.
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"We're very excited to partner with Spark on this research. We share common values as innovators in the field, and this device shows promise for people who are dependent on opioids," Dr. Tirado said.
"We understand the urgent need to provide an alternative, safe, and effective solution to assist OUD patients in taking the first, most challenging step in addiction recovery, overcoming withdrawal,” Dr. Navid Khodaparast, Spark's Chief Science Officer, said. “Our goal is to allow patients to comfortably transition through withdrawal to long-term maintenance treatment, such as opioid antagonist medications. This clinical trial gives Spark the necessary data to judiciously progress through the FDA clearance process and further enables Spark to help combat the opioid epidemic. We look forward to the day that the "Phoenix" solution is available at every point of care for those suffering opioid withdrawal."
According to the U.S Substance Abuse and Mental Health Services Administration, an estimated 10.3 million people are misusing opioid pain relievers and over 800 thousand people with heroin use in the past year. Of those, the vast majority who needed substance abuse care do not receive specialty substance use treatment due to the fear of withdrawal.