Actively Recruiting
A Randomized, Double-Blind, 3-Period Crossover Pharmacokinetic Study in Healthy Adults Comparing Combined Kava and Kratom Supplementation With Kava or Kratom Alone Under Fasted Conditions
Led by Botanic Tonics, LLC · Updated on 2026-05-13
18
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
B
Botanic Tonics, LLC
Lead Sponsor
N
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
Pharmacokinetics of Kava and Kratom Alone and in Combination
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged between 21 and 55 years at the time of consent
- Generally good health based on medical review, vital signs, lab tests, and physical exam
- Able to consume the study product fully within the required time
- Use nicotine, kava, or kratom products no more than 3 times in the past 3 months and willing to abstain 14 days before and during the study
- Body mass index (BMI) between 18.5 and 29.9 kg/m2 at screening and baseline
- Agree to follow restrictions on treatments and lifestyle during the study
- Maintain consistent diet and supplement habits for 3 months before and during the study
- Individuals with childbearing potential must have negative pregnancy tests and use effective contraception as specified
- Individuals able to impregnate others must use effective contraception as specified
- Male-born participants agree to abstain from sperm donation; female-born participants agree to abstain from ovum donation from screening through 30 days after last dose
- Abstain from alcohol for 48 hours before and during each treatment period
- Willing and able to consent, understand questionnaires, and complete study procedures
- Suitable veins for repeated blood draws
- Willing to attend video conference calls
- Agree not to donate blood until 3 months after study completion
You will not qualify if you...
- Pregnant, lactating, or planning pregnancy during the study
- Known allergy or sensitivity to study products or their ingredients
- Positive drug, cotinine, or breath alcohol test at screening or baseline
- Abnormal respiratory rate or oxygen saturation as judged by investigator
- Elevated liver enzymes or clinically significant lab abnormalities
- Low hemoglobin or hematocrit below specified levels for males and females
- Positive HIV screening
- Participation in another clinical trial or use of investigational product within 28 days before baseline
- Gastrointestinal disorders affecting swallowing or absorption, or history of related surgery
- Diagnosis of diabetes or thyroid disease
- High or low blood pressure outside specified ranges unless clinically insignificant
- History of heart, blood clotting, liver, or kidney disease
- Known genetic polymorphisms affecting metabolism enzymes
- Active asthma or recent significant asthma exacerbation
- Recent psychiatric treatment or hospitalization for major disorders
- Current use of medications affecting metabolism or central nervous system receptors that may interact with study treatments
- History of cancer within 5 years except certain skin or cervical cancers
- Recent significant blood or plasma donation
- Major surgery within 3 months before screening or planned during study
- History of substance or alcohol abuse
- Evidence of addictive tendencies as indicated by LDQ score
- Use of anxiolytics or sleep aids within 4 weeks before baseline
- Consuming more than two standard alcoholic drinks per day on average
- Excessive caffeine intake over 500 mg per day
- Any other medical conditions or treatments that may interfere with study participation or safety as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for medical review, lab tests, physical exam, and eligibility confirmation
Duration - Each treatment period lasts several days including dosing and pharmacokinetic sampling, with washout periods between; total study duration depends on completing all three treatment periods.
Participants receive three different oral herbal supplement treatments (Kava and Kratom combined, Kava alone, and Kratom alone) in a randomized sequence with washout periods between each treatment to compare pharmacokinetic profiles.
Multiple visits over 4 days for each treatment period to collect blood samples and safety assessments; participants complete all three treatment periods in sequence
Duration - Up to 30 days after last dose
Participants are monitored for safety and tolerability after completing all treatment periods, including assessments of subjective effects, well-being, and mood.
1 to 2 visits (in-person or remote) for safety follow-up and study completion assessments
Trial Site Locations
Total: 1 location
1
ApexTrials
Guelph, Ontario, Canada, N1G 0B4
Actively Recruiting
Research Team
A
Ambreen Atif, MD
S
Stephanie Recker
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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