Note: Single-source report; awaiting corroboration.
The National Institutes of Health (NIH) announced that its Investigational New Drug (IND) application for mitragynine, the main psychoactive compound in the kratom plant, has taken effect with the U.S. Food and Drug Administration (FDA). This approval allows NIH to begin a phase I clinical trial to evaluate mitragynine as a potential treatment for opioid use disorder.
Researchers from the NIH and the University of Florida developed a purified mitragynine formulation and conducted preclinical research leading to the IND application. According to NIH, mitragynine may have therapeutic effects related to opioid receptor interactions, with interest due to kratom's reported use for opioid withdrawal and pain relief.
Preclinical studies by NIH’s National Center for Advancing Translational Sciences, the National Institute on Drug Abuse, and the University of Florida showed mitragynine administration at various doses did not raise significant safety concerns in animal models. However, the compound has not yet been studied in humans.
The upcoming NIH-led trial will test the safety and tolerability of mitragynine in a randomized, double-blind, placebo-controlled design. NIH officials expressed hope this research may lead to new treatment options for millions affected by opioid use disorder and support recovery efforts.
This trial is part of the NIH HEAL Initiative®, which focuses on developing improved treatments for opioid addiction and related conditions.