Spark Biomedical, Inc., a neurostimulation device company developing solutions for opioid withdrawal, today 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 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.

Dr. Tirado commented, “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. Navid Khodaparast, Spark’s Chief Science Officer, noted, “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. 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 year1. Of those, the vast majority who needed substance abuse care do not receive specialty substance use treatment due to the fear of withdrawal.

About Spark Biomedical, Inc.

Spark Biomedical, Inc. is a Texas-based medical device company and developer of a wearable, over-the-ear, neurostimulation solution for opioid withdrawal and addiction relief. The Phoenix™ device delivers mild electrical stimulation to cranial nerve branches for the treatment of symptoms associated with opioid withdrawal. The company’s vision, to ignite a brighter future through neurostimulation, is fueled by its unique blend of scientific expertise, technical innovation, and deep medical device industry experience. For more information, visit www.sparkbiomedical.com or follow us on LinkedIn.

About CARMAhealth

CARMAhealth is a full-service healthcare provider with locations in Austin, TX, and Pompano Beach, FL providing comprehensive primary and psychiatric care for individuals with substance use disorder. Our team of specialized doctors, nurse practitioners, and mental health professionals provide stigma-free, evidence-based care to individuals in all stages of addiction, including withdrawal management, medication-assisted treatment, and primary and psychiatric medical care. CARMAhealth providers view addiction as a chronic condition that responds to treatment and improves over time and employ science and data in setting the standard for addiction medicine.

About Recovery Unplugged

Recovery Unplugged is a national addiction treatment organization, and the only addiction care provider to fully integrate music into our rehab programs. Combining traditional treatment resources like medical detox, comprehensive behavioral rehab, and aftercare with innovative and effective music-based therapies, Recovery Unplugged offers clients an effective, unique, and music-focused treatment experience. Our world-class doctors, therapists, and creative professionals leverage the power of music to help our clients heal from drugs and alcohol and reclaim their lives from addiction. This music-based treatment approach has helped clients from all over the country access their confidence, break down emotional barriers, and overcome their addictions.

1Results from the 2018 National Survey on Drug Use and Health: Graphics from the Key Findings Report, Center for Behavioral Health Statistics and Quality Substance Abuse and Mental Health Services Administration U.S. Department of Health and Human Services