The DEA Spent a Decade Trying to Schedule Kratom. NIH Just Gave It a Clinical Trial for OUD.

On June 1, 2026, an Investigational New Drug application for purified mitragynine — the primary active alkaloid in kratom — took effect with the FDA, clearing the path for a Phase 1 human safety trial. The trial (MG001, n=32) is expected to begin September 2026, with completion estimated April 2027. The researchers behind it are at NIH and the University of Florida. The application passed FDA’s IND review without a clinical hold — meaning the agency found no reason to stop it before it starts.

This is a significant scientific moment that will be immediately buried under a political debate that the science is not equipped to resolve.

Kratom (Mitragyna speciosa, a Southeast Asian plant traditionally used for energy and pain relief) has spent the last decade in a regulatory limbo that serves no one: the DEA attempted emergency scheduling in 2016, reversed after public outcry, and has been in an unresolved holding pattern since. Meanwhile, millions of Americans use kratom — some for energy, some for pain, some to self-manage opioid withdrawal. The 2023 NSDUH estimated about 1.8 million kratom users in the United States. A substantial fraction of them are managing opioid use without clinical support, which is its own public health story.

The MG001 trial will not resolve the policy question. Phase 1 trials are designed to answer a narrow question: is this compound safe enough in healthy human participants at the doses proposed for future study? Thirty-two people. A defined enrollment window. Safety and pharmacokinetics — how the drug behaves in the body, what it does to heart rate and liver enzymes and drug concentration in blood over time. This trial protocol is registered at ClinicalTrials.gov. It will not tell us whether purified mitragynine works better than buprenorphine, or whether it’s safe for long-term use in people with OUD, or whether kratom in its raw botanical form carries the same risk profile as a pharmaceutical isolate. Those are Phase 2 and Phase 3 questions, assuming Phase 1 goes cleanly, which takes years.

What the trial does do is legitimate the question. Kratom has been caught in a loop where DEA scheduling threats have made federal research funding nearly impossible, which has meant we have almost no good clinical data, which has made it harder to argue against scheduling, which has meant DEA scheduling threats have continued. NIH’s decision to fund IND-enabling research and file the application breaks that loop. Now there will be human data. It may show mitragynine is a viable therapeutic candidate. It may show it’s not. Either outcome is better than the current one, which is millions of people making decisions about a substance in the absence of any credible clinical evidence.

The politics will not follow the science quickly. The political debate around kratom — is it a dangerous drug or a legitimate botanical medicine? — has almost nothing to do with its pharmacological profile and almost everything to do with entrenched industry positions, DEA institutional preferences, and the difficulty of any substance holding multiple identities simultaneously. Phase 1 data will not settle that. But it starts the clock.