No medication is FDA-approved and no medical device is FDA-cleared to treat cocaine or methamphetamine use disorder, a gap NET Recovery is now trying to fill with a device already on the market for something else. The FDA granted the company’s NET Device Breakthrough Device Designation September 23 for reducing psychostimulant use in adults with stimulant use disorder, a designation that speeds up the agency’s review process without establishing that the device works for this use. The evidence NET Recovery has published so far for the new indication is not the kind of evidence that got the device cleared for its current one.
What the device is already cleared for
The NET Device, a battery-powered transcutaneous alternating current stimulator worn at both ears, received FDA 510(k) clearance in May 2024 for managing opioid withdrawal symptoms in patients with opioid use disorder, alongside standard medications and other withdrawal therapies. That clearance rested on a prospective, randomized, sham-controlled trial of 108 adults at a single US site, according to the FDA’s own published summary of the submission. Average withdrawal severity, measured on the Clinical Opiate Withdrawal Scale, fell 61 percent in the active-device group and 46 percent in the sham group one hour after treatment began, a gap the FDA’s summary reports as 15 percentage points with a plus-or-minus 10 percentage point interval. A larger share of the active group, 98 percent versus 84 percent, reached the trial’s predefined threshold for a clinically meaningful reduction. The submission also reported that blinding was not fully maintained: participants assigned to the active device were more likely to correctly identify their assignment than participants assigned to sham, though the specific test for that difference did not cross the conventional threshold for statistical significance. Active and sham stimulation can feel different without erasing the value of a control group, but it is a limitation the agency’s own summary records, not one the trial escaped.
What supports the new indication
Stimulant use disorder is a different claim, on a different evidentiary footing. NET Recovery has not published a sham-controlled trial for it. The closest public evidence is a real-world data analysis of 221 adults using the device in residential addiction treatment and detention settings, roughly half with stimulant use alone and half with combined stimulant and opioid use, accepted for publication in Frontiers in Psychiatry in August 2026. It tracked withdrawal severity on the Amphetamine Cessation Symptom Assessment scale and reported substantial reductions within an hour, continuing over several days, in both groups. It had no control arm, and its own authors recommend a sham-controlled randomized trial as the logical next step, the same design already completed for the opioid indication but not yet run for this one. NET Recovery has not stated whether this study was part of what it submitted to support the breakthrough application; the company’s release does not name the supporting evidence.
What the designation does and does not do
Breakthrough Device Designation is a process benefit, not a finding about the device. It gives NET Recovery more frequent interaction with FDA staff and priority review of a future submission. A device can qualify by showing a serious condition has no approved or cleared alternative treatment, one of several independent routes into the program that does not itself require prior clinical evidence that the device works for that specific use. Stimulant use disorder meets that bar today because nothing else does. NET Recovery’s own release is explicit that the designation “does not change FDA clearance or approval requirements” and that the device “is not currently authorized for the treatment of stimulant use disorder,” calling that use investigational. The company says it is designing a pivotal randomized controlled trial it expects to pursue through the FDA’s De Novo pathway, used when a device has no existing predicate for its claimed indication. No protocol has been registered publicly, and the company has not disclosed a trial size, timeline, or whether it will include a sham arm.
Why the gap still matters
The absence of any approved treatment for stimulant use disorder is not company framing alone. Cocaine and methamphetamine addiction have no FDA-approved pharmacotherapy, unlike opioid use disorder, which has three. Stimulant-involved deaths made up 59 percent of US overdose deaths from January 2021 through June 2024, according to the CDC’s own published surveillance data, with 43 percentage points of that share involving stimulants together with opioids and the remainder involving stimulants without opioids. A device that does not depend on a pharmacological target, if it eventually clears a controlled trial, would enter a market with essentially no approved incumbent to displace. That is what makes the designation worth tracking despite what it does not yet prove: it marks where regulators are willing to move quickly, not where the evidence currently stands.
What to watch
Whether NET Recovery registers a sham-controlled pivotal trial for stimulant use disorder, and what population, comparator, and primary endpoint it specifies. Whether the company discloses what evidence it submitted to support the breakthrough application. And whether the real-world study’s own recommendation, a controlled trial, becomes the next public data point or gets superseded by a De Novo filing built on the uncontrolled data already in hand.