A preliminary report from an ongoing FDA clinical study has found that kratom capsules, even in very high doses over a short period, are well-tolerated by participants. This pilot study, aimed at assessing the abuse potential of kratom, has been a significant focus for the FDA due to ongoing concerns about its safety and potential for misuse.
The “single-ascending dose” (SAD) study was announced by an FDA representative during a scientific symposium at the University of Florida in Orlando this past February. The study involved 40 healthy participants with no history of substance abuse. These participants were administered single ascending doses of kratom in capsule form, starting from 1 gram and increasing up to 12 grams, consumed within a five-minute period. Researchers closely monitored vital signs such as blood pressure, pulse, respiratory rate, and body temperature. The results indicated no significant adverse events, even at the highest doses.
It is important to note that in this study, participants only consumed plain leaf kratom, which is closer to the traditional form used for centuries in Southeast Asia. The study did not include other kratom-based products, such as highly concentrated liquid extracts or products containing 7-hydroxymitragynine, which might yield different results.
The FDA classifies kratom as a new dietary ingredient and has issued safety warnings about various kratom-based products. Previous FDA studies on kratom have been criticized for relying on poorly screened online reports and outdated science. Critics have also accused the FDA of having a general bias against dietary supplements.
FDA press officer Lauren-Jei McCarthy told the Arizona Mirror, “While there’s no date to provide at this time, we expect to publish the final study results of the FDA’s single ascending dose (SAD) study in the near future.“
A Potential Shift in Safety Perception
The findings from this study are particularly noteworthy given the FDA’s historical stance on kratom. The agency has previously warned consumers about the potential risks of kratom, including liver toxicity, seizures, and substance use disorder (SUD). In rare cases, there have been reports of deaths associated with kratom use.
Despite these warnings, the preliminary results from the SAD study suggest that plain leaf kratom, when used in controlled doses, may not pose the severe risks previously highlighted. This could potentially shift the narrative around kratom’s safety profile and its classification as a dietary supplement.
The most commonly reported side effect in the study was vomiting, which primarily occurred in participants who received the largest doses. This aligns with anecdotal reports from traditional users in Southeast Asia, where kratom has been used for its stimulant and analgesic properties for centuries.
As the FDA prepares to release the final results of this study, it will be crucial to see how these findings influence future regulatory decisions and public perception of kratom. The ongoing debate around kratom’s safety and efficacy underscores the need for more comprehensive research and balanced regulatory approaches.