The federal government has authorized a clinical trial to investigate kratom as a potential treatment for opioid addiction, marking a significant development amid increasing use and regulatory scrutiny of the plant-based product. The National Institutes of Health (NIH) announced on June 1 that researchers at the University of Florida will commence the first phase of clinical trials, with approval from the Food and Drug Administration (FDA).
Kratom is derived from Mitragyna speciosa, a tree native to Southeast Asia, and is commonly consumed in powder, pill, or tea form. It interacts with opioid receptors in the brain and is used by some Americans to manage anxiety, chronic pain, and symptoms of opioid withdrawal. However, a particular alkaloid in kratom, 7-hydroxymitragynine (7-OH), has raised public health concerns due to its potential for abuse and addiction at high doses.
The Los Angeles County Public Health Department linked six deaths last year to 7-OH combined with other substances, triggering a crackdown on kratom and related products throughout the region. Toxicology reports from some fatalities revealed traces of both kratom and 7-OH. This prompted authorities to prohibit sales of the substances until formal approvals and regulations are established.
The FDA has recommended classifying 7-OH as a controlled substance, citing risks associated with its use as a pain reliever. Dr. Mason Turner, president-elect of the California Society of Addiction Medicine, noted that patients sometimes use 7-OH without fully understanding its addictive potential. “Some patients sought it for chronic pain, not to get high, but still developed opioid use disorder,” he said.
Turner explained that as the medical community began limiting opioid prescriptions two decades ago, many patients sought alternatives, including kratom and 7-OH, to manage pain. He supports further research and regulation, considering kratom’s potential as a chronic pain therapy.
Recent studies underscore kratom’s growing popularity. A 2020 survey by Johns Hopkins found that a majority of users consumed kratom for chronic pain (91%), anxiety (67%), depression (64%), and opioid dependence (41%). More recent data from the University of Michigan and Texas State University analyzed National Survey on Drug Use and Health figures from 2021 to 2024, estimating that over five million Americans—including more than 100,000 adolescents aged 12 to 17—have used kratom. Usage appears highest among adults aged 21 to 34.
Despite being unapproved for medical use by the FDA, kratom and 7-OH products have been widely sold in stores until recent enforcement actions. In California, the Department of Public Health and Attorney General Rob Bonta filed legal actions in May against Ashlynn Marketing Group Inc., accusing the company of illegally manufacturing and distributing kratom products. Inspections at Ashlynn’s Santee facility found kratom powders, capsules, liquids, and chewable tablets being produced and sold despite embargoes placed in May 2025.
Follow-up inspections in October and April uncovered evidence of product tampering and continued manufacturing. The state has seized over $5 million worth of kratom-related products and is considering stronger regulations or outright bans on kratom and 7-OH. Dr. Erica Pan, California’s public health officer, emphasized the health risks, noting that these substances have been linked to addiction, overdose, and death.
The upcoming NIH-supported clinical trial marks a new chapter in understanding kratom’s potential benefits and risks as officials balance public health concerns with the demand for alternative pain and addiction treatments.