A Breakthrough Badge Isn't a Treatment. Meth Patients Need the One That Already Works.

Scott Simpson, a psychiatrist at CU Anschutz, keeps hearing the same sentence from other clinicians about patients who use methamphetamine: “There’s nothing I can do as a provider. There’s no treatment this patient can find.” He describes it as a misconception among providers, and it is a misconception that costs people care. Keep that sentence in your head for what follows, because this week it got a press release.

On September 23, FDA granted Breakthrough Device Designation to NET Recovery’s NET Device as an aid in reducing stimulant use in adults with cocaine or methamphetamine use disorder, according to the company. The device delivers a mild alternating electrical current through the skin, a technique called transcutaneous stimulation, and it is already FDA-cleared for managing opioid withdrawal symptoms. CEO Joe Winston said in the release that “there are millions of people suffering without any approved treatment options for stimulant use disorder.”

He is right about the gap. FDA itself said in 2023 that there is no approved medication for stimulant use disorder, and the company’s release says no medical device is cleared for it either.

A breakthrough badge is a promise about speed, not a finding about benefit.

Read the release closely and the limits are on the page. Per the company, a pivotal randomized trial is still being designed. The company anticipates a De Novo review, the FDA route for a new kind of low-risk device, and the device is not authorized for stimulant use disorder. Designation means the agency will work with the company faster. It says nothing yet about whether a person using meth uses less because of it. Until that trial reports, this is a candidate, and the honest answer to a patient who asks whether they can get it is no, not yet, and nobody knows if it will work.

That is fine. New tools should be built. What is not fine is the pattern where a clinic hears “breakthrough” and quietly files stimulant treatment under “wait for the device.” People who use methamphetamine are not waiting. In 2023, according to the CDC, nearly 60,000 overdose deaths involved cocaine or psychostimulants.

There is a treatment with a track record available now. Contingency management pays people, in small prizes or vouchers, for testing negative or showing up, and California has federal approval to cover it through Medicaid for stimulant use disorder. Coverage is state by state, and providers generally have to be certified to bill it, so a program in your state may not exist yet. Here is the do-this-week move for a clinic: find out whether your state Medicaid office has a contingency management path, and if it doesn’t, ask what it would take. At the same time, write down what your team offers a person in stimulant psychosis today, because the answer should not be “nothing.”

If you use, and someone at a clinic has told you there is nothing for you, that was a statement about their program. It was not a statement about you, and naloxone is still yours to carry, since supply can carry fentanyl nobody chose.

The people who need help with meth are not a trial population waiting for a device. They are somebody’s Thursday, and they deserve a clinic that has an answer today.