FDA Greenlights First Human Trial of Mitragynine for Opioid Use Disorder
核心洞察
The FDA has approved an IND application for the first randomized, double-blind, placebo-controlled clinical trial of mitragynine (搜索), the main psychoactive compound in kratom, in humans.
The NIH-sponsored Phase 1 study will enroll approximately 32 healthy volunteers with a recent history of opioid use to evaluate the safety, tolerability, and pharmacokinetics of a purified mitragynine (搜索) formulation called MG001 (搜索).
NIDA Director Nora Volkow described the trial as a "major step toward expanding treatment options for the millions of Americans struggling with opioid use disorder (搜索)."
The Food and Drug Administration (搜索) has approved an Investigational New Drug (IND) application to study mitragynine (搜索), the main psychoactive compound in the kratom plant, as a potential treatment for opioid use disorder (搜索) (OUD). The National Institutes of Health-sponsored study marks the first randomized, double-blind, placebo-controlled clinical trial evaluating mitragynine in humans.
"This research study is the first time the new medication MG001 (搜索) is being tested in people," states a National Institute on Drug Abuse summary. "MG001 is a formulation of mitragynine (搜索), a compound that comes from a plant called Mitragyna speciosa (sometimes known as kratom), which some people use on their own to help manage symptoms of opioid withdrawal. The purpose of this study is to understand how safe MG001 is, how well it is tolerated, and how the body processes it."
Study Design and Objectives
Researchers from NIDA and the University of Florida developed a "purified formulation" of mitragynine (搜索) and anticipate enrolling approximately 32 volunteers. The study is part of the federal Helping to End Addiction Long-term (HEAL) Initiative. In preclinical studies on animals, researchers said several doses of mitragynine did not raise any significant safety concerns.
The primary focus of the Phase 1 trial is safety and tolerability, not efficacy for treating OUD. "We've seen the potential of mitragynine (搜索) 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 (搜索) and support a path to recovery," said Joni Rutter, PhD, Director of the NIH's National Center for Advancing Translational Sciences.
A Shifting Regulatory Landscape
The FDA's decision appears to confirm a somewhat ambiguous statement of support from President Donald Trump a few weeks earlier. "We're looking very seriously at natural 7-OH and getting that approved—natural 7-OH," Trump said at an Oval Office event in May. "And we'll take a look at that very strongly, I think [Centers for Medicare & Medicaid Services Administrator Mehmet] Oz and everybody were looking to see if we can do something there. A lot of people are asking for it."
NIDA Director Nora Volkow described the IND approval as a "major step toward expanding treatment options for the millions of Americans struggling with opioid use disorder (搜索), which has contributed to historically high overdose mortality rates."
The development unfolds against a complex regulatory backdrop. In July 2025, the FDA recommended placing 7-hydroxymitragynine (搜索) (7-OH)—a more potent alkaloid present in small quantities in all kratom products and also synthetically concentrated—under Schedule I of the Controlled Substances Act. The agency explained it was targeting 7-OH specifically and was "not focused on natural kratom leaf products." However, ten months later, the DEA has not moved to schedule 7-OH.
Real-World Use and Advocacy
Kratom has for years been informally used to manage symptoms of OUD. In a survey of over 6,000 kratom users conducted by Pain News Network, about one in ten said they used kratom as a treatment for OUD or alcoholism, with over 90% saying it was "very effective." Many reported that kratom reduced their cravings and helped wean them from drugs.
"For years, opponents of kratom have attempted to portray natural kratom leaf as a public health threat," said Mac Haddow, Senior Fellow on Public Policy for the American Kratom Association (搜索). "The decision by NIH to move forward with this research sends exactly the opposite message. Federal scientists believe the available evidence justifies studying kratom's potential role in helping address one of the most devastating public health crises in America, the opioid overdose epidemic."
The new NIH study represents a significant pivot for federal health agencies. In 2022, the FDA sent warning letters to four companies telling them to stop marketing kratom as a treatment for opioid addiction, stating that "these products have not been determined by FDA to be safe and effective" and that "the unproven treatments could cause patients to forego or delay FDA-approved treatments for opioid addiction or withdrawal." That same year, the NIH released a study warning that nearly a third of kratom users met diagnostic criteria for "kratom use disorder."
With the IND now in effect, the government has come full circle on kratom's therapeutic potential. Once dismissed as unproven, mitragynine (搜索) is now entering formal clinical evaluation as a potential solution to one of America's most pressing public health crises.