NIH Launches First Human Trial of Kratom Compound to Treat Opioid Use Disorder

Why it matters

After years of warning against kratom, federal health authorities are now sponsoring the first human clinical trial of a kratom-derived compound — a historic shift that could open the door to new evidence-based treatments for opioid use disorder, a condition that contributed to record overdose mortality.

The big picture

The NIH's decision to approve an Investigational New Drug application for mitragynine marks a pivotal moment in U.S. kratom policy. It represents an acknowledgment that kratom's primary alkaloid may have therapeutic value, even while the FDA is simultaneously pushing to schedule its derivative 7-OH. This dual-track federal approach reflects the complex and contested science around kratom.

Key findings

• NIH approved an Investigational New Drug (IND) application for mitragynine as a potential opioid use disorder (OUD) treatment
• A Phase One placebo-controlled study will enroll 32 healthy volunteers with a recent history of opioid use
• University of Florida researchers are co-leading the study with NIH's National Center for Advancing Translational Sciences
• Preclinical animal studies found no significant safety concerns at several tested doses
• NIDA Director Nora Volkow called it "a major step toward expanding treatment options for millions of Americans struggling with OUD"

What they say

"We've seen the potential of mitragynine in the lab, and now we're finally able to examine its potential in people. Hopefully this work will lead to a new treatment option for people with opioid use disorder and support a path to recovery." — Joni Rutter, PhD, Director of NIH's National Center for Advancing Translational Sciences

Bottom line

The NIH's first human clinical trial of mitragynine — kratom's primary compound — marks a historic federal pivot toward studying kratom's therapeutic potential rather than simply warning against its dangers.