Dallas, TX, June 12, 2025 (GLOBE NEWSWIRE) -- Spark Biomedical, a leader in wearable neurostimulation technology, has completed enrollment for its pivotal clinical trial, which aims to improve treatment retention for adults with opioid use disorder. Funded by the National Institute on Drug Abuse (NIDA) under the HEAL Initiative, the trial was conducted in partnership with the Hazelden Betty Ford Foundation and Gaudenzia.
With relapse rates exceeding 70% among individuals with opioid use disorder and synthetic opioids like fentanyl driving overdose deaths to record highs, the need for innovative interventions has never been greater. Spark Biomedical’s study investigated the use of wearable transcutaneous auricular neurostimulation (tAN® therapy) as a novel method to improve acute and long-term recovery. Additionally, the study examined the potential synergistic effects of tAN and two other approved medications for opioid use disorder (MOUD), lofexidine and XR-naltrexone. By helping individuals stay engaged in treatment longer, the trial seeks to support lasting recovery without additional opioid-based medications.
Spark Biomedical’s Co-founder & Chief Science Officer, Dr. Navid Khodaparast, Ph.D., shared, “Completing enrollment marks a critical milestone in advancing transcutaneous auricular neurostimulation as a non-invasive, drug-free therapy for opioid use disorder. This study not only evaluates the standalone efficacy of wearable neurostimulation in enhancing treatment retention but also explores its potential to synergize with established pharmacotherapies.”
Leaders from both partner institutions emphasized the importance of the study’s potential:
“At Hazelden Betty Ford, we are committed to advancing science-based, compassionate care for those affected by opioid use disorder,” said Alta DeRoo, M.D., Chief Medical Officer, Hazelden Betty Ford Foundation. “This pivotal trial represents non-pharmaceutical options to treat opioid withdrawal. In addition to FDA-approved medications for opioid use disorder, this non-pharmaceutical option will empower patients in their treatment options. This provides us with more weapons and a hopeful step forward in combatting one of the most urgent public health challenges of our time.”
"This trial represents more than a data point—it’s a breakthrough in how we think about sustaining engagement in treatment for opioid use disorder,” said Dr. Bhavani Raghavan Lobo, Psy.D., Chief Research Officer, Gaudenzia. “We were honored to lead enrollment and completion efforts, and we’re incredibly proud that so many participants entrusted us with their care. These results are a testament to our team’s clinical excellence and compassion, and they reinforce the importance of investing in non-invasive, science-driven solutions to address the nation’s overdose crisis.”
Results from this research will contribute to an anticipated FDA submission and mark a significant milestone in the advancement of drug-free solutions for opioid use disorder.
About Gaudenzia
Gaudenzia, Inc. is one of the largest nonprofit providers of treatment for people with substance use and co-occurring disorders in the United States, with 51 facilities operating in Pennsylvania, Maryland, Delaware, and Washington, D.C. The agency serves about 15,000 individuals annually and operates 120 programs providing a full continuum of care. Since 1968, Gaudenzia has provided specialized services and programs for all demographics, including pregnant and parenting women, adolescents, people with substance use and co-occurring disorders, and more. Those seeking help can call Gaudenzia’s Treatment and Referral HelpLine at 833-976-HELP (4357). For more information, visit www.Gaudenzia.org
About the Hazelden Betty Ford Foundation
Harnessing science, love and the wisdom of lived experience, the Hazelden Betty Ford Foundation is a force of healing and hope for individuals, families and communities affected by substance use and mental health conditions. As the nation’s foremost nonprofit provider of comprehensive behavioral health care, the Foundation leads the way in helping society rise above stigma and overcome addiction. With a legacy that began in 1949 and includes the 1982 founding of the Betty Ford Center, the Foundation now has treatment centers and telehealth services nationwide as well as a network of collaborators throughout health care. Charitable support and a commitment to innovation drive ongoing advances in care, research, programs and services to impact more lives. In addition to clinical care, Hazelden Betty Ford encompasses a graduate school, a publishing division, a research center, thought leadership and advocacy, professional and medical education programs, school-based prevention resources and a specialized program for children—with a commitment to diversity, equity and inclusion in all of its endeavors. Learn more at HazeldenBettyFord.org.
About Spark Biomedical
Spark Biomedical, Inc. Is a leading U.S.-based medical device developer, committed to unlocking the potential of bioelectronic medicine and bringing to market novel wearable neurostimulation treatment options in behavioral health, women's health, hemostasis, pediatrics, and chronic pain. Spark leverages its neuroscience and engineering expertise to empower healthcare providers and researchers with innovative, evidence-based tools designed to address complex care situations which exceed the capabilities of existing treatment options. Spark has received funding from federal institutions, such as the NIH and DoD, and continues to partner with private and academic institutions. Spark Biomedical is empowering a better way forward for the future of patient care and medical technology. For more information, visit sparkbiomedical.com.
For more information, please contact Udim Obot at udim.obot@sparkbiomedical.com
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Udim Obot Spark Biomedical 844-654-7775 udim.obot@sparkbiomedical.com