Actively Recruiting
Pharmacokinetics of Kava and Kratom Alone and in Combination
Led by Botanic Tonics, LLC · Updated on 2026-05-13
18
Participants Needed
1
Research Sites
17 weeks
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
This study is being conducted to evaluate how different formulations of the Feel Free® Tonic containing Kava, Kratom, or a combination of both are processed in the body in healthy adults. 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.
CONDITIONS
Official Title
Pharmacokinetics of Kava and Kratom Alone and in Combination
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults between 21 and 55 years of age at the time of consent
- Generally healthy as determined by medical history, vital signs, lab tests, and physical exam
- Able to consume the study product fully within the specified timeframe
- Use nicotine, kava, and 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 between 18.5 and 29.9 kg/m2 at screening and first dosing visit
- Agree to follow restrictions on treatments and lifestyle during the study
- Maintain consistent diet, supplement intake, and lifestyle for 3 months before screening and during the study
- Negative pregnancy test at screening and before each treatment for individuals with childbearing potential
- Use highly effective contraception from 14 days before first dose through 30 days after last dose if able to impregnate or become pregnant
- 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
- Able and willing to consent, understand questionnaires, and complete study procedures
- Suitable veins for repeated blood draws
- Willing to attend video conference calls with study staff
- 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 allergies or sensitivities to study products or their ingredients
- Positive drug or alcohol tests at screening or dosing visits
- Abnormal respiratory rate or oxygen levels at screening or baseline
- Elevated liver enzymes or other significant lab abnormalities
- Low hemoglobin or hematocrit levels at screening
- Positive HIV test at screening
- Participation in another clinical trial or use of investigational products within 28 days before dosing
- Gastrointestinal disorders affecting swallowing, digestion, or absorption, or history of related surgeries
- Diagnosed diabetes or thyroid disease
- High blood pressure (>=140/90 mmHg) at screening or dosing
- Low blood pressure (<90/60 mmHg) at baseline unless asymptomatic and clinically insignificant
- History of heart, blood clotting, kidney, or liver diseases
- Known genetic polymorphisms affecting drug metabolism enzymes
- Active asthma or significant asthma exacerbations in past 12 months
- Recent or ongoing treatment or hospitalization for psychiatric disorders
- Use of medications metabolized by CYP enzymes or with CNS depressant/opioid effects that may interact with study treatments
- History of cancer within past 5 years except certain localized skin or cervical cancers
- Recent significant blood loss or donations
- Major surgery within 3 months before screening or planned during the study
- History of alcohol or substance abuse including kratom
- High addictive tendency indicated by LDQ score
- Use of anxiolytics or sleep aids within 4 weeks before dosing
- Consuming more than 2 standard alcoholic drinks daily on average for 4 weeks
- Excessive caffeine intake over 500 mg daily
- Any other medical conditions or treatments that may affect study participation or safety as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
ApexTrials
Guelph, Ontario, Canada, N1G 0B4
Actively Recruiting
Research Team
A
Ambreen Atif, MD
CONTACT
S
Stephanie Recker
CONTACT
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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