The FDA Just Cleared the First Human Trial of Kratom as an OUD Treatment

On June 4, Filter’s Kastalia Medrano broke the news that the NIH’s Investigational New Drug application for mitragynine — the primary psychoactive compound in kratom — has taken effect with the FDA. What follows is the first randomized, double-blind, placebo-controlled clinical trial of mitragynine as a potential treatment for opioid use disorder in human subjects.

This is a milestone, and it’s worth saying clearly why: kratom has been the subject of fierce regulatory ambiguity for years. The DEA considered emergency scheduling in 2016, then pulled back. The FDA has maintained that mitragynine acts on opioid receptors and should be regulated accordingly. An estimated 10–15 million Americans use kratom, primarily as a self-managed treatment for opioid withdrawal, chronic pain, and anxiety — despite the absence of approved indication, controlled clinical evidence, or standardized dosing. The FDA’s willingness to allow an IND to proceed represents, at minimum, an acknowledgment that the question of kratom’s therapeutic potential deserves a scientific answer rather than a regulatory presumption.

A safety study published in January 2026 in Therapeutic Drug Monitoring — funded by the FDA, randomized, double-blind, placebo-controlled, 116 healthy adult volunteers, 47 days — found kratom leaf powder “safe and well tolerated” at the tested doses, with no serious adverse events and no deaths. That study didn’t evaluate kratom’s efficacy as a treatment, only its safety profile in controlled conditions. The new NIH trial extends that inquiry into efficacy and therapeutic potential.

The simultaneous context: the CDC’s MMWR reported a 1,200 percent increase in kratom-related poison center calls from 2015 through 2025. The sharp spike in 2025 correlated with the emergence of high-potency, semi-synthetic kratom formulations — particularly 7-hydroxymitragynine (7-OH), which the FDA has flagged as “a potent opioid that poses an emerging public health threat.” The kratom that is the subject of the NIH trial — dried leaf powder at controlled doses — is not the same product as the concentrated 7-OH extracts showing up in poison center data. The two are increasingly diverging into distinct substances with different risk profiles, a distinction that the regulatory framework hasn’t fully caught up to.

The trial’s result, whenever it comes, will either provide the first evidence base for kratom as a legitimate MAT option for OUD — a development that would matter enormously in communities where buprenorphine access is scarce — or it will clarify that the perceived benefits are not replicated under controlled conditions. Either answer is more useful than the current regulatory limbo.

For context on Arizona’s treatment options for opioid use disorder, including MAT resources, see Rize Recovery’s opioid treatment guide.