Study Comparing How Kava and Kratom Supplements Are Processed Alone and Together in Healthy Adults

What this Trial Is About

Researchers are studying how different formulations of the Feel Free4 Tonic, containing Kava, Kratom, or both combined, are processed in the bodies of healthy adults. The goal is to compare how the body absorbs and handles these herbal supplements individually and together, focusing on their pharmacokinetic profiles and safety. This randomized, double-blind study will also assess participants subjective effects, mood, and well-being. The study involves three oral liquid herbal supplements one with both Kava and Kratom, one with Kava alone, and one with Kratom alone. Participants will receive all three treatments in a random order, with washout periods between each to allow for clear comparisons. The research team will measure the levels of key compounds like Kavain and Mitragynine in the blood over time to understand how each supplement behaves when taken. Participants will attend multiple visits where blood samples will be collected to track the concentration of these compounds up to 72 hours after dosing. They will also complete questionnaires about mood and subjective experiences. Safety and tolerability will be monitored throughout. The total study duration includes three treatment periods and washout intervals, lasting until September 2026. Participants must meet health criteria and age requirements to join.

Pharmacokinetics of Kava and Kratom Alone and in Combination