The National Institutes of Health (NIH) today announced that its Investigational New Drug (IND) application for mitragynine, the primary psychoactive compound found in Mitragyna speciosa (kratom), has taken effect with the U.S. Food and Drug Administration (FDA). The IND paves 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 formulation of mitragynine to be used in the trial, as well as the preclinical work that led to the submission of the IND application.
"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," said Nora Volkow, M.D., director of NIH's National Institute on Drug Abuse (NIDA).
Interest in kratom, a tropical tree found in southeast Asia, as a treatment for opioid use disorder has increased in recent years, with many reportedly using it for opioid withdrawal, pain, and other conditions as well.
While the kratom plant contains many compounds known to interact with opioid receptors, research indicates that its potential therapeutic effects are likely driven by the slow conversion of mitragynine in the body. Preclinical studies led by scientists at the University of Florida and NIH's National Center for Advancing Translational Sciences (NCATS) and NIDA have demonstrated that mitragynine administration, across several doses, did not raise significant safety concerns in animal models.
However, the compound in isolation has yet to be studied in humans. With the IND in effect, investigators can now begin that work.
NIH scientists are planning to conduct the first randomized, double-blind, placebo-controlled study to assess the safety and tolerability of the mitragynine formulation in humans.
"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," said NCATS Director Joni Rutter, Ph.D.
The trial is part of the Helping to End Addiction Long-term® Initiative, or NIH HEAL Initiative ®
NIH HEAL Initiative and Helping to End Addiction Long-term are registered service marks of the U.S. Department of Health and Human Services.
