Botanic Tonics Launches First Randomized Clinical Trial on Kava-Kratom Pharmacokinetics in Healthy Adults

Why it matters

This is the first randomized, double-blind crossover trial to systematically compare how kava and kratom are absorbed, distributed, and eliminated—both alone and in combination. The data could inform safety guidelines for combined-use products increasingly popular in kava bars.

The big picture

Combined kava-kratom products—especially "Feel Free" style tonics—have surged in popularity. Regulators and clinicians lack pharmacokinetic data on how these botanicals interact in the body. The CDC has previously flagged rising serious outcomes from combined kava-kratom use. Botanic Tonics, maker of Feel Free tonics, is funding this trial through Nutrasource, an independent Canadian clinical research organization.

Key findings

• The trial (NCT07583407) is a randomized, double-blind, 3-period crossover study in 18 healthy adults aged 21-55.
• Participants will receive three treatments in randomized order: combined kava-kratom tonic, kava alone, and kratom alone—each separated by washout periods.
• Primary endpoints include AUC0-24 for kavain, dihydrokavain, mitragynine, and 7-hydroxymitragynine—tracking systemic exposure over 24 hours.
• Secondary endpoints include safety, tolerability, subjective effects, mood, and opioid withdrawal symptom scales.
• The study started May 4, 2026, with a primary completion date of September 4, 2026, conducted at ApexTrials in Guelph, Ontario, Canada.

What they say

Per the trial record, the goal is to "compare the pharmacokinetic profiles and safety of the combined herbal formulation with Kava alone and Kratom alone to better understand how these ingredients behave when taken individually versus together."

Bottom line

**The first clinical pharmacokinetics trial on kava-kratom combination products is now underway, a significant step toward understanding how these popular beverages interact in the body and informing evidence-based safety guidelines.**