NIH Launches First Human Trial of Mitragynine as Opioid Use Disorder Treatment

Why it matters

This is the first federally sanctioned human safety study of mitragynine, kratom's primary psychoactive compound, and could open a new treatment pathway for the millions of Americans with opioid use disorder. If shown safe, it may eventually provide a plant-based alternative to existing OUD medications.

The big picture

Kratom has been used informally by many people to manage opioid withdrawal for years, but it has never undergone rigorous human clinical trials. The NIH's Investigational New Drug (IND) application, cleared by the FDA, is the formal first step toward generating the safety data required for potential drug approval. This trial is part of the NIH HEAL Initiative, which is dedicated to accelerating scientific solutions to the opioid crisis.

Key findings

• The FDA has cleared an Investigational New Drug (IND) application for mitragynine, paving the way for a phase I clinical trial
• Researchers at NIH and University of Florida developed a purified formulation of mitragynine (MG001) for the study
• The trial will be the first randomized, double-blind, placebo-controlled study of mitragynine in humans, enrolling ~32 volunteers
• Preclinical studies showed mitragynine did not raise significant safety concerns in animal models across multiple doses
• NIDA Director Nora Volkow called it a "major step toward expanding treatment options" for opioid use disorder

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

The NIH has received FDA clearance to begin the first human clinical trial of a purified kratom compound as a potential opioid use disorder treatment — a historic milestone for kratom science.