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Testing the efficacy of transcutaneous auricular neurostimulation (tAN) to improve symptoms associated with naloxone-precipitated withdrawal.

Award Number: UG3DA064373
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/15/2026
PERIOD OF PERFORMANCE END DATE: 04/30/2028

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Testing the efficacy of transcutaneous auricular neurostimulation (tAN) to improve symptoms associated with naloxone-precipitated withdrawal. - In medical settings, naloxone-precipitated opioid withdrawal following an overdose reversal can lead to adverse patient reactions and increase discharge against medical advice. In out-of-hospital settings, the fear of inducing withdrawal may preclude or delay the use of naloxone (NLX) by laypersons. Insufficient management of withdrawal in both environments can lead to opioid-seeking, resulting in additional overintoxication. Non- invasive neuromodulation has demonstrated efficacy in managing abstinence-induced opioid withdrawal with minimal side effects. The Sparrow Ascent ® transcutaneously stimulates branches of the vagus (15 Hz) and trigeminal nerves (100 Hz) on and around the ear to increase parasympathetic activation and release of endorphins. In a randomized, double-blind, sham-controlled trial, non-invasive transcutaneous auricular neurostimulation (tAN) using Sparrow ® led to significant reductions (45.9%) in withdrawal scale scores following abrupt opioid discontinuation. Though findings with abstinence-induced withdrawal suggest clinical efficacy for precipitated withdrawal, these two forms of withdrawal vary in time course, severity, symptomology, and response to medications. Furthermore, adjusting the tAN stimulation frequencies could improve effectiveness. The goal of this UG3-UH3 proposal is to test the efficacy of non-invasive tAN of the vagus and trigeminal nerves to attenuate withdrawal induced by naloxone. During the UG3 phase, the investigators will evaluate the effects of various tAN stimulation frequencies on naloxone-precipitated withdrawal (4 mg, intranasal), relative to the FDA-cleared frequency of 15 & 100 Hz. Participants will be randomly assigned to one of four testing conditions: 1. NLX 4.0mg→ Sham tAN 2. NLX 4.0mg→ Active tAN 5 & 50 Hz (low) 3. NLX 4.0mg→ Active tAN 15&100 Hz (FDA cleared setting) and 4. NLX 4.0mg→ Active tAN 25 & 150 Hz (high), (N=20 per group). Non-treatment-seeking, illicit opioid users will be tested in an ecological validity, naloxone- challenge model. Following naloxone administration, Clinical and Subjective Opiate Withdrawal Scales (COWS and SOWS, respectively) will be administered for 60 minutes. The 1° aim of the UG3 phase is to determine the most efficacious stimulation frequency as measured by the change in COWS (1°) and SOWS (2°). Go/No-Go Criterion: A ≥15% reduction in COWS score (active vs sham tAN) must be observed to progress to the UH3 phase. The UH3 phase will test the most efficacious stimulation frequency in comparison to lofexidine (0.54 mg: double-blind, double-dummy) with an extended period of observation (4 hours). The 1° aim of the UH3 phase is to assess the ability of tAN of the vagus and trigeminal nerves to produce acute and sustained reductions in withdrawal, compare the side effects profile to lofexidine (2°) and observe for combined treatment effects (2°). The investigation will also explore the ability of tAN to attenuate opioid craving, as preclinical research has found that vagus nerve stimulation inhibits cue-induced reinstatement of opioid-seeking. Devices treating withdrawal could be implemented in settings where pharmacotherapies are not available.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $717,986 )
2026	2026	RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC.	1051 RIVERSIDE DR	NEW YORK	NY	10032	NEW YORK	USA	Drug Use and Addiction Research Programs	000	1	5/1/2026	NEW	$717,986
														Subtotal = $717,986

Grand Total All Awards = $717,986

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Testing the efficacy of transcutaneous auricular neurostimulation (tAN) to improve symptoms associated with naloxone-precipitated withdrawal.

Award Number: UG3DA064373

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 05/15/2026

PERIOD OF PERFORMANCE END DATE: 04/30/2028

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