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ORIGINAL RESEARCH article

Front. Psychiatry
Sec. Addictive Disorders
Volume 16 - 2025 | doi: 10.3389/fpsyt.2025.1510428

A Randomized, Sham-Controlled Clinical Trial to Evaluate the NET Device™ for Reducing Withdrawal Symptom Severity During Opioid Discontinuation

Provisionally accepted
Mark K Greenwald Mark K Greenwald 1*Cynthia L Arfken Cynthia L Arfken 1Joe R Winston Joe R Winston 2
  • 1 School of Medicine, Wayne State University, Detroit, United States
  • 2 NET Recovery Corp™, United States, United States

The final, formatted version of the article will be published soon.

    Background: Neuromodulation is a promising approach for opioid discontinuation, as not all patients with opioid use disorder (OUD) seek pharmacotherapy. The NET Device is a non-invasive, battery-powered, portable, device that provides bilateral, transcranial, transcutaneous, alternating current stimulation (tACS) for patients experiencing opioid withdrawal. This clinical trial prospectively evaluated whether NET Device utilization is effective for persons with OUD undergoing opioid discontinuation without medications for OUD (MOUD). Methods: This randomized, sham-controlled trial was conducted at a single residential treatment center. Persons with OUD undergoing opioid discontinuation were assigned to active or sham device treatment. Clinical Opiate Withdrawal Scale (COWS) total scores were measured prior to and during device use. We tested whether active stimulation would produce a clinically meaningful (>15%) decrease in COWS score from baseline to 1-hr post-stimulation, compared to sham. Results: 108 participants (55 sham, 53 active; 59.3% male, 89.8% white; 71.3% fentanyl-positive) form the intent-to-treat dataset. Mean (+1 SD) COWS score in the active device group decreased from baseline (18.1+4.4) to 1-hr (7.0+4.1); this 61.3% decrease (d=2.14) exceeded the pre-specified 15% criterion. COWS scores decreased more for active (-11.1+5.2) than sham (-8.8+6.3), p<.05, d=-.41. A higher proportion of participants in active vs. sham showed ≥15% reduction in COWS (98.1% vs. 83.6%), p=.016. Device utilization was longer for active than sham, 43.9+46.2 vs. 30.0+39.2 hours, p=.008, and fewer participants requested MOUD (26% vs. 49%, p<0.02). Conclusion: The NET Device is effective, safe and well-tolerated for reducing opioid withdrawal symptoms. This device received FDA market clearance in May 2024.

    Keywords: Opioid use disorder, detoxification, withdrawal, craving, Transcranial electrical stimulation, tACS Clinical Trial Registration: ClinicalTrials.gov with identifier NCT04916600. Study design

    Received: 12 Oct 2024; Accepted: 13 Jan 2025.

    Copyright: © 2025 Greenwald, Arfken and Winston. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Mark K Greenwald, School of Medicine, Wayne State University, Detroit, United States

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.