Spark Biomedical Completes Enrollment for Pivotal Opioid Use Disorder Trial

Spark Biomedical, a pioneer in wearable neurostimulation, has completed enrollment in its pivotal clinical trial targeting improved treatment retention for adults with opioid use disorder (OUD). The study, funded by the NIH’s HEAL Initiative and conducted in collaboration with the Hazelden Betty Ford Foundation and Gaudenzia, explores Spark’s transcutaneous auricular neurostimulation (tAN®) therapy as a non-opioid tool for recovery.

With overdose deaths surging and relapse rates topping 70%, the need for innovative treatments is urgent. The trial also evaluated the combined effects of tAN with lofexidine and XR-naltrexone—two FDA-approved medications for OUD. Spark’s goal: to keep more individuals in treatment and support long-term recovery without relying on additional opioid-based medications.

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