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Spark Biomedical Completes Enrollment in a Neurostimulation Pivotal Trial for Opioid Use Disorder
Spark Biomedical Completes Enrollment in a Neurostimulation Pivotal Trial for Opioid Use Disorder

Yahoo

time12-06-2025

  • Health
  • Yahoo

Spark Biomedical Completes Enrollment in a Neurostimulation Pivotal Trial for Opioid Use Disorder

Final enrollment concludes for Spark Biomedical's pivotal study investigating a non-invasive, drug-free neurostimulation therapy aimed at improving treatment retention for adults with opioid use disorder. 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 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 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 For more information, please contact Udim Obot at ### CONTACT: Udim Obot Spark Biomedical 844-654-7775

Loving Giving Local: Gaudenzia
Loving Giving Local: Gaudenzia

Yahoo

time24-04-2025

  • Health
  • Yahoo

Loving Giving Local: Gaudenzia

Helping people overcome addictions — That's the mission of an organization that got a visit from Loving Giving Local. In more than 56 years of service in Pennsylvania, Gaudenzia has helped more than 350,000 people recover their lives. 'Gaudenzia is a treatment provider in Erie for substance abuse disorders and mental health conditions. And wherever you are in your recovery journey, we have a program for you,' said Lisa Hermann-Bradley, program director. Gaudenzia offers withdrawal management and residential treatment services, and both traditional and intensive outpatient services. Hermann-Bradley said, 'All our treatment services are individualized, with group and individual services. We even have a couple residential programs that are specifically for women and women with children. where their children can be with them in treatment if that would be a barrier to getting help. Whatever we need, we can provide.' Hermann-Bradley said it's a lifelong journey of wellness and recovery just like any other illness. 'The best thing we can do is instill hope in others and let them know there is another way to live,' said Hermann-Bradley. Gaudenzia was this week's recipient of $250 from Auto Express. In presenting the check, Joe Askins of Auto Express said, 'Guadenzia provides programs that are necessary to our community so for us to be able to deliver Loving Giving Local here today and to learn the donation we bring is going to go toward something fun for their clients. That's what loving giving local is all about.'. Gaudenzia this week, who will it be next week? Join us each Wednesday morning on Good Morning Erie on JET 24 or Good Day Erie on FOX 66 to find out what local non-profit gets a visit from Loving Giving Local. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

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