NIH Clears First Human Trial of Isolated Mitragynine as Opioid Use Disorder Treatment

Why it matters

This marks the first time NIH has received FDA clearance to study isolated mitragynine—kratom's primary alkaloid—in human clinical trials, potentially opening a new treatment pathway for opioid use disorder. With over 80,000 opioid overdose deaths annually, any viable new treatment option is urgently needed.

The big picture

Kratom's active compound, mitragynine, has been studied in animals for years, showing promise for opioid withdrawal and pain management without triggering significant safety concerns in preclinical models. A collaboration between NIH's National Center for Advancing Translational Sciences (NCATS), NIDA, and University of Florida researchers has produced a purified mitragynine formulation (MG001) ready for human testing. The Phase I trial will be the first randomized, double-blind, placebo-controlled human safety and tolerability study of this compound.

Key findings

• NIH's Investigational New Drug (IND) application for mitragynine has been cleared by the FDA, enabling a Phase I human clinical trial
• The purified formulation (MG001) was developed by researchers at NIH and the University of Florida
• Preclinical studies showed mitragynine administration across several doses did not raise significant safety concerns in animal models
• The trial will be the first randomized, double-blind, placebo-controlled study of mitragynine in humans
• The research is part of the NIH HEAL Initiative (Helping to End Addiction Long-term)

What they say

"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).

Bottom line

For the first time, the NIH has FDA clearance to test a purified kratom alkaloid in humans as a potential opioid use disorder treatment—a landmark step that could reshape addiction medicine.