Federal Cooperative Agreement Summary

The Research Foundation For Mental Hygiene, Inc., through its New York State Psychiatric Institute division, received a $717,986 Cooperative Agreement award from the National Institute on Drug Abuse (NIDA) under the Drug Use and Addiction Research Programs (CFDA 93.279) effective May 15, 2026, with completion targeted for April 30, 2028. This award supports a UG3-UH3 phased research initiative to evaluate the efficacy of transcutaneous auricular neurostimulation (TAN) in attenuating symptoms of naloxone-precipitated opioid withdrawal in medical settings. The research addresses a critical clinical gap, as naloxone-induced withdrawal currently leads to adverse patient reactions and discharge against medical advice, while fear of withdrawal induction may delay naloxone administration in out-of-hospital settings.

During the UG3 phase, investigators will test various TAN stimulation frequencies applied to the vagus and trigeminal nerves using the FDA-cleared SPARROW device to determine optimal parameters for managing naloxone-precipitated withdrawal. The study will employ a randomized, double-blind, sham-controlled design comparing treatment conditions that vary TAN frequencies (including the standard FDA-cleared 15 and 100 Hz settings and alternative 5 and 50 Hz frequencies) against sham stimulation following intranasal naloxone administration. This research builds on prior evidence demonstrating 45.9% reductions in withdrawal symptom severity using TAN for abstinence-induced withdrawal, with the goal of establishing non-invasive neuromodulation as an evidence-based intervention to reduce adverse outcomes and improve medication acceptance in overdose reversal scenarios.