A self-administered neurostimulation device for people with opioid use disorder who choose to undergo opioid discontinuation is an effective, safe and well-tolerated short-term therapy for rapidly suppressing – within one hour – opioid withdrawal discomfort in a controlled inpatient environment, according to the published results of a clinical trial.
“NET Device as a Non-Pharmacological Alternative to Medication for Promoting Opioid Abstinence,” launched in November 2021, with the final patient enrolled in July 2023, was led by principal investigator Mark Greenwald, Ph.D., professor and Gertrude Levin Endowed Chair in Addiction and Pain Biology in the Wayne State University Department of Psychiatry and Behavioral Neurosciences.
The results, “A randomized, sham-controlled clinical trial to evaluate the NET Device™ for reducing withdrawal symptom severity during opioid discontinuation,” was published in Frontiers in Psychiatry on Feb. 18 as the first of at least two planned publications based on the obtained results of trial, which led to FDA clearance of the neurostimulation medical device in May 2024.
The trial was conducted at four residential treatment facilities (two for females, two for males) in Kentucky, with data analyzed at Wayne State.
“The device is intended for the patient to self-administer stimulation for as long as they perceive benefit, up to seven days, but the average participant used it about three days,” Dr. Greenwald said. “For the second planned publication, we are currently analyzing data from this trial to determine whether there is any longer-term benefit on outpatient substance use after having received the stimulation only during the inpatient period.”
Cynthia Arfken, Ph.D., a biostatistician and professor of Psychiatry and Behavioral Neurosciences, and trial sponsor NET Recovery Corp. Chief Executive Officer Joe Winston contributed to the study.
Neuromodulation is a promising approach for opioid discontinuation, as not all patients with opioid use disorder seek pharmacotherapy. The NET, or NeuroElectric Therapy Device, is a non-invasive, battery-powered, portable device that provides bilateral, transcranial, transcutaneous alternating current stimulation for patients experiencing opioid withdrawal. The device delivers alternating current via surface electrodes placed trans-cranially on the mastoid processes, located at the base of the skull on each side of the head. The electrodes are connected by a cable to a control box. The device produces low-amperage waveforms at proprietary controlled frequencies and pulse widths. The individual controls the intensity of stimulation by turning a knob on the control box.
In 2022, the team published a manuscript describing the experimental design in the journal Contemporary Clinical Trials Communications.
NET has been used clinically for many years in Europe and South Africa, and pilot study data in Scotland and the United States suggested it can help patients with OUD, Dr. Greenwald said.
Presently, the NET Device™ is available only in Kentucky, Dr. Greenwald said. Since the trial’s completion, the company is looking to expand production and geographic distribution to other treatment facilities, and is working to establish reimbursement for treatment with the device.
More trial information is available at ClinicalTrials.gov, identifier NCT04916600.
For more information on Dr. Greenwald’s research, visit https://psychiatry.med.wayne.edu/profile/aa2678