NIH launches kratom trials as 7-OH deaths mount

kratom trials – The same kratom compounds tied to deaths in California—especially 7-hydroxymitragynine, or 7-OH—are now being studied by the federal government as a potential treatment for opioid addiction. NIH announced the first phase of clinical trials will begin, even as

By the time the federal government cleared the path for new research, California had already been counting the cost in its own hospitals and morgues.

Kratom—an extract from the leaves of Mitragyna speciosa. a Southeast Asian tree—has surged in popularity in the U.S. as a pain remedy and self-treatment for opioid withdrawal symptoms, anxiety, and chronic pain. But in concentrated, synthetic forms, it has also been linked to serious harms. One component. 7-hydroxymitragynine. known as 7-OH. has emerged as the flashpoint: officials warn it has the potential for abuse and addiction in high doses.

On June 1. the National Institutes of Health announced that researchers from the University of Florida would begin the first phase of clinical trials on kratom to evaluate it as a potential treatment for opioid addiction. The research is to be done with the FDA’s approval, according to NIH’s announcement.

Dr. Nora Volkow, director of NIH’s National Institute on Drug Abuse, said in a statement that the trial push 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.”

The tension is hard to miss. In California. last year’s Los Angeles County Public Health Department linked the deaths of six county residents to the use of 7-OH mixed with other substances. Toxicology screens for some of the deceased revealed both kratom and 7-OH. That finding helped fuel a countywide crackdown of products with either compound because they’re unregulated.

Although there is no scientific consensus on whether kratom has therapeutic value. the FDA has recommended that its potent 7-OH form be classified as a controlled substance. The risk. researchers and clinicians say. is not just theoretical for people who buy 7-OH expecting relief that feels like kratom.

Dr. Mason Turner, president-elect of the California Society of Addiction Medicine, described patients who used 7-OH for chronic pain and ended up losing control of their opioid-related recovery.

“I have a couple of patients that I work with who use 7-OH for chronic pain management. not realizing the potential of the medication. and then developed an opioid use disorder. ” Turner said. “I think in that case it was very clear they were seeking it for the chronic pain. not to get high. not to have some kind of experience. but really to reduce their pain.”.

Turner said that about two decades ago, the healthcare industry began acknowledging the limits and risks of prescribing opioids for chronic pain, with some doctors pulling back on prescriptions because of potential abuse. For some patients, he said, that change left a gap.

“Maybe they don’t get a good benefit, or maybe the benefit from some of the other treatments is not as robust as what they got from opioids,” Turner said. “So they seek out some of these illicit products … or they look for kratom or 7-OH to be able to mitigate the pain.”

Turner said he supports further research into kratom and regulation because “it could be worth exploring as a treatment for chronic pain.”

While NIH moves toward clinical trials, regulators say the retail market is still ahead of the science.

The FDA has stated that neither kratom nor 7-OH are approved as drug products. dietary supplements or food additives—yet that hasn’t stopped storefronts and companies from selling them in those categories. In California. the state’s record shows how quickly enforcement can reshape availability: up until November. kratom and 7-OH products could be found in smoke shops and specialty stores in California. but that has stopped.

In an email to The Times, the California Department of Public Health said, “Until kratom and its pharmacologically active key ingredients mitragynine and 7-OH are approved for use, they will remain classified as adulterants in drugs, dietary supplements and foods.”

That position is showing up in court.

In May, the California Department of Public Health and Attorney General Rob Bonta filed a complaint against Ashlynn Marketing Group Inc. in San Diego County Superior Court. The complaint accuses the company of repeatedly flouting state regulations on kratom products.

The filing seeks a judge’s order to condemn and destroy the embargoed kratom products. halt ongoing unlawful manufacturing. and impose civil penalties. The California Department of Public Health said it is acting because Ashlynn’s continued manufacture and sale poses what it called a “clear and preventable public‑health risk” and violates state and federal law.

Dr. Erica Pan, the department’s director and state public health officer, said, “7-OH and kratom-derived products have been associated with addiction, serious health harms, overdose and death.”

The complaint describes enforcement steps that, if proven, suggest an attempt to keep operating despite being told to stop.

The state alleges that inspectors visited Ashlynn Marketing Group’s facility in Santee in May 2025 and found kratom powders. capsules. liquids and chewable tablets being manufactured and held for sale. During the visit. inspectors issued an embargo to prohibit the sale and distribution of all kratom-related materials on-site. according to the complaint.

Public health inspectors then conducted follow-up visits at the facility in October and April, “collecting evidence at both inspections that indicated embargoed kratom products had been moved, tampered with and repackaged,” according to public health officials.

“ In addition, investigators observed evidence of continued manufacturing and distribution of kratom materials,” officials said. “The firm’s owner continues to manufacture kratom products and ships orders weekly.”

To date, the California Department of Public Health has seized more than $5 million worth of kratom and 7-OH products, a spokesperson for the department told The Times.

California and Los Angeles County are also considering whether to tighten regulations or ban the compounds altogether.

For the people using kratom—often chasing pain relief or trying to blunt withdrawal symptoms—the coming trial is a potential turning point. But for public-health officials. the ongoing enforcement fight underscores the central contradiction in the current moment: a substance critics say is unapproved and unsafe in the marketplace is now entering carefully controlled federal research. even as state and local agencies describe continued risk from products sold outside that framework.

A John Hopkins survey conducted in 2020 reported that 91% of respondents used kratom to treat chronic pain. 67% to treat anxiety. 64% for depression and 41% to treat opioid dependence. A more recent study by the University of Michigan and Texas State University found that more than 5 million people in the U.S. including more than 100. 000 children ages 12 to 17. have used kratom. The study analyzed data from the National Survey on Drug Use and Health collected between 2021 and 2024. and researchers said use is at an all-time high and increasing despite numerous state-level bans.

In that study, people between the ages of 21 and 34 said they used kratom at least once, and 1% said they used it in the last year. The share of children ages 12 and older who said they had used kratom increased from 1.6% in 2021 to 1.9% in 2024.

For many, the promise is simple: find a treatment that helps. The danger, regulators say, is what happens when users get the unregulated products instead.

The question now facing lawmakers. clinicians. and families is whether NIH’s trial can produce the kind of clarity that California’s deaths and enforcement actions have demanded—before more people get caught in the gap between craving relief and getting something far more powerful than they expected.

kratom 7-OH opioid addiction NIH clinical trials FDA California Department of Public Health Rob Bonta Ashlynn Marketing Group Los Angeles County addiction medicine