FDA Grants Breakthrough Status to Device for Stimulant Use Disorder

The Food and Drug Administration has granted Breakthrough Device Designation to NET Recovery's wearable brain stimulation device for reducing psychostimulant use in adults with stimulant use disorder, the Costa Mesa, California-based company announced on September 23. The designation applies to a proposed new indication covering both cocaine use disorder and amphetamine-type stimulant use disorder—including methamphetamine—at a time when no medication is FDA-approved and no medical device is FDA-cleared for either condition.

A Critical Gap in Addiction Treatment

The designation arrives in the middle of what public health officials have called the most undertreated segment of the overdose crisis. According to data cited by the company, roughly 4.5 million Americans struggle with concurrent opioid and stimulant use, and stimulant-involved overdose deaths accounted for a substantial share of U.S. overdose mortality between 2021 and 2024. Unlike opioid use disorder, which has three FDA-approved medication classes—buprenorphine, methadone, and naltrexone—stimulant addiction currently has no pharmacological standard of care. Clinicians rely almost entirely on behavioral therapy and contingency management, leaving patients with limited options when cravings and withdrawal drive relapse.

The polysubstance dimension adds urgency. Fentanyl remains the leading cause of overdose death nationwide, but methamphetamine and cocaine are increasingly present in the same fatal events, complicating both emergency response and long-term treatment. A device capable of addressing stimulant use—especially one already cleared for opioid withdrawal—could offer a rare cross-cutting tool for patients caught between multiple dependencies.

How the Device Works

The NET Device is a transcutaneous alternating current stimulator, or tACS, worn on the head during the acute withdrawal phase. Surface electrodes placed bilaterally on the mastoid processes behind the ears deliver low-amperage alternating current waveforms believed to modulate dopaminergic, serotonergic, and endogenous opioid systems disrupted by 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.

FDA originally cleared the device in May 2024 for a narrow indication: managing opioid withdrawal symptoms in conjunction with standard symptomatic medications and other therapies under clinical supervision. The new Breakthrough Designation seeks to expand that authorization to cover stimulant use disorder, a significantly larger patient population with even fewer treatment options.

Breakthrough Device Designation does not constitute FDA clearance or approval. It provides expedited review and priority status for future submissions, recognizing that the device targets a life-threatening condition for which no approved alternatives exist. NET Recovery said it is now designing a pivotal randomized controlled trial intended to support marketing authorization through what the company believes will be the De Novo review pathway.

Evidence From Earlier Trials

The designation builds on peer-reviewed findings published earlier this year. In a three-month follow-up study published in Frontiers in Psychiatry and conducted by researchers at Wayne State University School of Medicine, 103 adults with opioid use disorder across four Kentucky residential centers used the device during detoxification. Participants who wore it for at least 24 hours reported fewer days of both opioid and stimulant use in the 12 weeks following discharge than those who used it for shorter durations or not at all.

A separate randomized, sham-controlled trial published in January found that active stimulation produced a 61 percent reduction in Clinical Opiate Withdrawal Scale scores within one hour, compared with 46 percent in the sham group. Significantly, only 26 percent of active-device users requested medications for opioid use disorder during their inpatient stay, versus 49 percent of sham users.

Those earlier results were observational with respect to stimulant use, and the company acknowledges that self-selection bias may have played a role—patients who felt relief might have been more motivated overall. The pivotal trial now being designed will need to establish causation specifically for stimulant outcomes under controlled conditions.

What Stimulant Users Currently Face

The treatment landscape for cocaine and methamphetamine addiction has remained nearly unchanged for decades. Behavioral therapies such as contingency management, which provides tangible rewards for abstinence, show modest efficacy in clinical trials but are difficult to scale and rarely available outside research settings or specialized programs. The Matrix Model, a structured outpatient protocol, requires intensive clinician time that most community treatment centers cannot afford. No pharmacotherapy has survived Phase III trials for either cocaine or methamphetamine use disorder, despite decades of research into candidates including disulfiram, modafinil, and topiramate.

This absence of medical options has real consequences. Patients presenting with polysubstance use involving opioids and stimulants often receive medication for the opioid component while the stimulant dependence goes unaddressed. Buprenorphine stabilizes opioid cravings but offers no direct benefit for concurrent methamphetamine use. Naloxone reverses opioid overdoses but has no effect on stimulant toxicity. The result is a treatment system that manages half the problem and hopes the other half resolves through willpower and counseling alone.

Regulatory and Clinical Context

FDA's Breakthrough Device program is designed to speed development of technologies that treat debilitating or life-threatening conditions when no approved alternatives exist. The designation gives NET Recovery more frequent communication with FDA reviewers and a streamlined path through pre-submission meetings, but the company must still complete a rigorous pivotal trial and demonstrate safety and efficacy before marketing authorization.

If successful, the device would become the first FDA-authorized medical technology specifically for stimulant use disorder. That would represent a meaningful expansion of the addiction treatment toolkit at a moment when the epidemic has shifted toward polysubstance use that existing medications cannot fully address. Whether neurostimulation can fill that gap will depend on the data from the upcoming randomized trial—and on whether treatment programs, insurers, and policymakers are prepared to integrate a wearable device into a field historically divided between medication advocates and abstinence-based approaches.

NET Recovery's previous coverage of the device's dual-substance findings can be found in our earlier report on the clinical trial results.