This post breaks down what the study did, what participants experienced, what the labs showed (especially liver enzymes), and what the authors concluded about abuse potential and withdrawal. Then we translate it into practical takeaways for real-world “plain leaf kratom” consumers. What Study Was This?
This is the Single Ascending Doses of Kratom in Healthy Nondependent Adults With Opioid Experience Study done by the FDA. Design: randomized, double-blind, placebo-controlled, dose-escalation trial in 116 healthy adults (49 active, 67 placebo).Product: MitraLeaf, an encapsulated dried Mitragyna speciosa leaf powder with defined mitragynine content and very low 7-OH listed on the Certificate of Analysis.
Dosing plan:
- Single dose (SD): one of four mitragynine dose levels delivered via leaf powder.
- Multiple dose (MD): the same people then took 15 once-daily doses at their assigned level.
- Follow-up: monitoring continued for 23 days after the last dose.
The Big Headline Result
No serious adverse events and no deaths occurred in the active kratom group or placebo group.
The authors concluded the dried leaf powder was “safe and well tolerated” at the tested doses, with no evidence of meaningful abuse potential or withdrawal during the study window.
That is not a “kratom is harmless forever” card. It is a strong data point: controlled conditions, known product, known doses, careful monitoring.