FDA-Cleared Brain Stimulation Device Shows Promise for Treating Both Opioid and Stimulant Addiction

A wearable neurostimulation device cleared by the FDA for easing opioid withdrawal symptoms has demonstrated an unexpected capacity to reduce both opioid and stimulant use for months after residential treatment—a finding that could reshape approaches to polysubstance addiction at a time when nearly half of all fatal overdoses involve multiple drug types.

The NET Device, a transcutaneous alternating current stimulator worn on the head during detoxification, showed in a newly published peer-reviewed study that patients who used it for at least 24 hours during residential treatment reported significantly fewer days of opioid and stimulant use over the subsequent three months. Published in Frontiers in Psychiatry and conducted by researchers from Wayne State University School of Medicine, the study followed 103 adults with opioid use disorder across four Kentucky residential treatment centers—most of whom had been using fentanyl and methamphetamine concurrently.

Filling a Critical Gap in Stimulant Addiction Treatment

The timing of these findings arrives at an inflection point in the overdose crisis. More than three million Americans struggle with both opioid and stimulant use disorders, according to CDC data, yet while medications exist for opioid addiction—buprenorphine, methadone, naltrexone—there are zero FDA-approved pharmacological treatments for cocaine or methamphetamine addiction. Behavioral therapy remains the only evidence-based option, leaving clinicians with limited tools when patients present with the increasingly common combination of fentanyl and methamphetamine dependence.

"These important findings demonstrate that, for patients interested in non-pharmacological intervention, experiencing device stimulation for a day or more has the potential to reduce drug use across multiple substance types," said Dr. Mark Greenwald, Professor and Director of the Substance Addiction Research Division at Wayne State University and lead author of the study. "This could offer a new tool for helping patients stabilize early in recovery and remain engaged in care."

The device delivers multiple low-amperage alternating current waveforms through surface electrodes placed bilaterally on the mastoid processes behind the ears—a form of transcranial stimulation believed to modulate endogenous opioid, dopaminergic, and serotonergic systems disrupted during chronic substance use. Patients self-administer the treatment, adjusting intensity as needed, and can wear it continuously except when bathing for up to seven days during the acute withdrawal phase.

What the Data Showed

In the recent three-month follow-up study, researchers found that participants who used the NET Device for at least one full day (24 hours or more) during their initial residential stay exhibited markedly different trajectories than those who used it for shorter durations or not at all. These patients stayed longer in the residential program and, crucially, reported fewer cumulative days of both opioid and stimulant use in the 12 weeks following discharge.

The magnitude of this effect matters in a field where relapse rates routinely exceed 60% within the first year. While the study did not establish causation—self-selection bias could play a role, as patients who felt the device helped them might have been more motivated overall—the consistency of the reduction across two distinct drug classes suggests a shared neurobiological mechanism rather than placebo effects alone.

A separate randomized, sham-controlled trial published in January 2025 in the same journal established the device's efficacy for its FDA-cleared indication: reducing opioid withdrawal severity. That pivotal trial of 108 participants found that active stimulation produced a clinically meaningful 61% reduction in Clinical Opiate Withdrawal Scale scores within one hour, compared to 46% in the sham group. Significantly, 98% of participants in the active device group achieved at least a 15% reduction in withdrawal symptoms—the threshold for clinical meaningfulness—versus 84% in sham. Only 26% of active-device users requested medications for opioid use disorder during their inpatient stay, compared to 49% of sham users.

Those who perceived they were receiving active stimulation—regardless of actual device assignment—used the device four times longer on average than those who perceived sham treatment, suggesting that subjective relief drove continued use rather than external enforcement.

Mechanisms Still Under Investigation

The precise neurobiological pathways through which transcranial alternating current stimulation might attenuate cravings and withdrawal across multiple substance classes remain incompletely understood. Leading hypotheses center on frequency-dependent modulation of the autonomic nervous system and neurotransmitter systems—particularly dopamine, serotonin, and endogenous opioids—that become dysregulated during chronic drug exposure.

Electrical neurostimulation at varying frequencies has been shown in animal models and earlier human studies to promote neuroplastic changes, potentially allowing the brain to "relearn" baseline functioning after prolonged substance use. The NET Device delivers dynamically varying waveforms optimized for skin impedance and electrode conductance, which may contribute to high patient tolerability—a critical factor given that discomfort often leads to early discontinuation of medical devices in addiction settings.

Notably, the device adjusts its output based on each participant's drug screen results at treatment entry. Different electronic waveforms correspond to subtypes of polysubstance use identified through prior clinical observation and animal research. Whether this customization enhances efficacy remains an open question, but the fact that participants with fentanyl-positive screens used the device longer (52.9 hours on average) than fentanyl-negative users (21.2 hours) suggests differential perceived benefit by substance profile.

Practical Considerations and Limitations

The FDA cleared the NET Device for market in May 2024 with a narrow indication: "intended to be used in patients experiencing opioid withdrawal in conjunction with standard symptomatic medications and other therapies for opioid withdrawal symptoms under the supervision of trained clinical personnel." The device is not approved for stimulant addiction, and the new findings—while promising—represent observational evidence requiring validation in larger randomized trials specifically designed to test stimulant use outcomes.

"This study reinforces what we're seeing in treatment settings across the country," said Joe Winston, CEO and co-founder of NET Recovery Corp and study co-author. "When people can find relief from their symptoms, they're able to stay in care longer and build the stability needed for recovery."

Safety concerns remain minimal. Across both studies, adverse events were rare: one participant reported headaches; no one reported electrical, mechanical, or thermal hazards, skin irritation, dizziness, or worsening withdrawal. The device has not been tested in pregnant or breastfeeding individuals, people under 18, those with cardiac pacemakers, serious heart conditions, stroke history, brain tumors, epilepsy, or active psychotic illness—populations excluded from the trials.

Access poses another barrier. The device requires supervision by trained clinical personnel and is currently deployed primarily in residential treatment settings rather than outpatient clinics or home use. Pricing and insurance coverage details have not been publicly disclosed, though NET Recovery's business model appears to target institutional purchasers rather than individual consumers.

The study population—adults voluntarily admitted to rural Kentucky residential facilities, 90% white, seeking opioid discontinuation without medications—limits generalizability. Whether the device would show comparable efficacy in more diverse demographic groups, urban settings, or among patients mandated to treatment remains untested. Additionally, participants who enrolled explicitly preferred non-medication approaches to detoxification, a self-selecting group that may not represent the broader addiction treatment population.

Implications for a Shifting Epidemic

The overdose crisis has entered what some researchers call a "fifth wave" characterized by polysubstance use—fentanyl mixed with methamphetamine, cocaine, or xylazine—creating clinical challenges that single-target medications cannot address. Naloxone reverses opioid overdoses but has no effect on stimulant toxicity. Buprenorphine stabilizes opioid cravings but offers no direct benefit for concurrent methamphetamine use. Clinicians treating patients with dual dependencies have historically been forced to address each substance sequentially or simultaneously with separate, sometimes incompatible, therapeutic modalities.

A device capable of reducing use across multiple drug classes—if validated in larger trials—would represent a fundamentally different treatment architecture. Rather than substance-specific receptor blockade or agonist substitution, neurostimulation targets upstream circuits governing reward, motivation, and stress response that cut across addiction types. This approach mirrors recent interest in medications like GLP-1 agonists (semaglutide, tirzepatide), which preliminary evidence suggests may reduce alcohol, nicotine, and opioid cravings through shared neurobiological pathways.

The parallels extend to implementation challenges. Just as GLP-1 drugs for addiction face regulatory, access, and cost hurdles despite promising data, neurostimulation devices must navigate FDA approval pathways, establish reimbursement codes, train practitioners, and overcome skepticism in a field historically divided between medication-assisted treatment advocates and abstinence-focused programs.

NET Recovery's emphasis on offering the device as a "non-pharmacological option" risks entanglement in the ideological battles that have plagued addiction medicine for decades. Framing neurostimulation as an alternative to medications may appeal to patients and programs philosophically opposed to methadone or buprenorphine, but it also invites misuse by entities seeking to justify withholding evidence-based medications. The FDA's clearance language—specifying use "in conjunction with standard symptomatic medications and other therapies"—attempts to forestall this outcome, but enforcement in decentralized residential treatment settings remains uneven.

Still, for the estimated 48 million Americans with substance use disorders, fewer than 10% of whom receive any treatment, expanding the toolkit holds inherent value. If a wearable device can help patients tolerate the acute misery of withdrawal long enough to engage with longer-term therapies—whether behavioral, pharmacological, or both—it merits serious consideration regardless of ideological preferences.

The NET Device study adds to a growing body of research on bioelectric medicine for psychiatric and neurological conditions, a field that has struggled to translate laboratory findings into widespread clinical adoption. Transcranial magnetic stimulation for treatment-resistant depression, vagus nerve stimulation for epilepsy, and deep brain stimulation for Parkinson's disease have all faced similar arcs: initial enthusiasm, rigorous trials, FDA clearance, then slow uptake limited by cost, access, and practitioner unfamiliarity. Whether neurostimulation for addiction follows this pattern or achieves broader integration depends less on the technology itself than on the health systems, payers, and policymakers who determine which interventions become standard of care.

For now, the research offers something rare in addiction medicine: a signal that a non-opioid, non-stimulant intervention might address the intractable problem of polysubstance dependence. Whether that signal amplifies into a durable treatment option will require years of additional study, real-world implementation data, and the kind of sustained investment that has historically eluded addiction research. But in a crisis where innovation has often lagged behind the pace of harm, even preliminary evidence of a dual-action tool represents a step forward worth watching.