The National Institutes of Health (NIH) announced today that its Investigational New Drug (IND) application for mitragynine, the primary psychoactive compound from kratom, has taken effect with the U.S. Food and Drug Administration (FDA). This significant step clears the way for an NIH-led phase I clinical trial to evaluate mitragynine as a potential treatment for opioid use disorder.
Researchers at NIH and the University of Florida developed the purified mitragynine formulation for the trial, alongside preclinical work supporting the IND application. Nora Volkow, M.D., director of NIH’s National Institute on Drug Abuse (NIDA), said, "This IND is a major step toward expanding treatment options for the millions of Americans struggling with opioid use disorder, which has contributed to historically high overdose mortality rates."
Interest in kratom, a tropical tree from Southeast Asia, has grown as a reported treatment for opioid withdrawal and pain. Preclinical studies by scientists at the University of Florida, NIH’s National Center for Advancing Translational Sciences (NCATS), and NIDA showed that mitragynine administration did not raise significant safety concerns in animal models.
With the IND now active, investigators can proceed with the first randomized, double-blind, placebo-controlled study to assess the safety and tolerability of the mitragynine formulation in humans. NCATS Director Joni Rutter, Ph.D., said, "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." The trial is part of the NIH HEAL Initiative.