red vein kratom leaves
The Food and Drug Administration has approved an Investigational New Drug Application (IND) to study mitragynine, the main psychoactive compound in kratom, as a potential treatment for opioid use disorder (OUD). The National Institutes of Health-sponsored study will be the first randomized, double-blind, placebo-controlled clinical trial evaluating mitragynine in humans. It also gives some indication of the Trump administration’s intentions regarding the paradoxical, highly contentious regulatory landscape that kratom shares with mitragynine’s more potent form, 7-OH.
“This research study is the first time the new medication MG001 is being tested in people,” states a National Institute on Drug Abuse summary. “MG001 is a formulation of mitragynine, 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.”
Researchers from NIDA and the University of Florida developed a “purified formulation” of mitragynine, and anticipate enrolling about 32 volunteers. The study is part of the federal Helping to End Addiction Long-term® (HEAL) Initiative. In a June 1 announcement that the IND had taken effect, NIDA Director Nora Volkow described it as a “major step toward expanding treatment options for the millions of Americans struggling with opioid use disorder.”
Kratom has for years been informally used to manage symptoms of OUD. It’s also prompted various attempts to ban it. But more recently, bolstered by the Drug Enforcement Administration’s demonization of synthetic drugs in contrast to plant-based drugs, these attempts have honed in on 7-OH.
7-hydroxymitragynine, commonly known as 7-OH, is an active byproduct of mitragynine, and so small quantities of it are naturally present in all kratom products. But it’s also been synthetically concentrated to make more products that are much more potent than traditional kratom products, and these are what public officials are referring to when they talk about 7-OH.
The FDA’s decision appears to confirm a somewhat ambiguous statement of support from President Trump a few weeks earlier.
In July 2025 the FDA recommended placing 7-OH under Schedule I of the Controlled Substances Act, and formally initiated the review process with the DEA. The agency explained that it was targeting 7-OH specifically, and “not focused on natural kratom leaf products.”
Since then, amid an explosion of interest from media and law enforcement, 7-OH has become the subject of multiple public health alerts including misleading claims about overdose deaths. Media began using the moniker “gas station drugs” to refer to 7-OH and other unregulated synthetic opioids and cannabinoids. Legislators proposed bills to ban all kratom products, or ban all 7-OH products, or regulate kratom while banning 7-OH, and so on. Some of these bills have advanced in the same states at the same time. Kratom products by definition include all 7-OH products, but technically 7-OH is also present in all kratom products, prompting a lot of discussions about thresholds—similar to how hemp-derived CBD products have to contain less than 0.3 percent THC, otherwise they’re legally considered marijuana.
But 10 months later, the DEA has not moved to schedule 7-OH. Meanwhile it seems increasingly likely that the administration plans to eventually approve kratom as a treatment for OUD, which would make it ineligible for Schedule I and thus complicate any attempt to place 7-OH under Schedule I (not that the DEA would be unwilling to proceed with that kind of thing). The FDA clearing NIDA to begin human trials for its mitragynine product 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.”
The phrase “natural 7-OH” has done nothing to clear up confusion about synthetic 7-OH versus plant-based kratom, but Trump probably meant the latter.
Image (cropped) via Wikimedia Commons/Creative Commons 4.0
