Pharmacokinetics of Kava and Kratom Alone and in Combination
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-55
SponsorBotanic Tonics, LLC
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults who are between 21 - 55 years of age (inclusive) at the time of signing the informed consent.
In otherwise good general health, as deemed by the investigator (based on review of medical history, vital signs, laboratory safety tests, and physical examination performed at screening and/or before the first dose of study product).
Are able to consume the study product completely within the specified timeframe.
Not currently using, defined as ≤ 3 uses in the past 3 months prior to Visit 2, any nicotine-containing products (patches, gums, vapes, etc.), kava products, and/or kratom products, and willing to abstain starting 14 days prior to Visit 2 and throughout the study.
Disqualifiers
Individuals who are lactating, planning to become pregnant during the study, or pregnant as confirmed by a positive pregnancy test during study visits.
Have a known sensitivity, intolerability, or allergy to any of the study products, their excipients, or rescue medication.
Demonstrates a positive urine drug screen test for compounds listed in Table 8 4 at the Screening Visit or Visit 2, a positive urine cotinine test at the Screening Visit or Visit 2, or a positive breath alcohol test at Screening Visit or Visit 2.
Have abnormal respiratory rate (RR) or SpO2 measurements at Screening or Baseline at the discretion of the investigator.
Trial design
Design model
Parallel
Treatments tested in this trial
Kava and Kratom Herbal Supplement
Dietary supplementHalf- Strength Feel Free Classic Tonic (TP1)
Kava Herbal Supplement
Dietary supplementKava Only Variant - Feel Free Tonic (TP2)
Kratom Herbal Supplement
Dietary supplementKratom Only Variant - Feel Free Tonic (TP3)
Treatment groups
18 Participants
are divided into 3 treatment groupsGroup A: Half- Strength Feel Free Classic Tonic (TP1)Active comparator 1 intervention
Group B: Kava Only Variant - Feel Free Tonic (TP2)Active comparator 1 intervention
Group C: Kratom Only Variant - Feel Free Tonic (TP3)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24) for Kavain
AUC0-24 for kavain following single-dose administration of Kava alone or combined Kava and Kratom
Time frame
Day 1 and Day 2 of each treatment period (0-24 hours post-dose)2
Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24) for Dihydrokavain
AUC0-24 for dihydrokavain following single-dose administration of Kava alone or combined Kava and Kratom
Time frame
Day 1 and Day 2 of each treatment period (0-24 hours post-dose)3
Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24) for Mitragynine
AUC0-24 for mitragynine following single-dose administration of Kratom alone or combined Kava and Kratom
Time frame
Day 1 and Day 2 of each treatment period (0-24 hours post-dose)4
Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24) for 7-Hydroxymitragynine
AUC0-24 for 7-Hydroxymitragynine following single-dose administration of Kratom alone or combined Kava and Kratom
Time frame
Day 1 and Day 2 of each treatment period (0-24 hours post-dose)Secondary outcomes
1
Area Under the Plasma Concentration-Time Curve From Time Zero to 72 Hours (AUC0-72) for Kavain
AUC0-72 for kavain following single-dose administration of Kava alone or combined Kava and Kratom
Time frame
Day 1 to Day 4 of each treatment period (0-72 hours post-dose)2
Maximum Observed Plasma Concentration (Cmax) for Kavain
Peak plasma concentration of kavain following single-dose administration of Kava alone or combined Kava and Kratom
Time frame
Day 1 of each treatment period (0-12 hours post-dose)3
Time to Maximum Plasma Concentration (Tmax) for Kavain
Time to reach maximum observed plasma concentration of kavain following single-dose administration of Kava alone or combined Kava and Kratom
Time frame
Day 1 and Day 2 of each treatment period (0-24 hours post-dose)4
Terminal Elimination Half-Life (T½) for Kavain
Terminal elimination half-life of kavain following single-dose administration of Kava alone or combined Kava and Kratom
Time frame
Day 1 to Day 4 of each treatment period (0-72 hours post-dose)Other outcomes
1
Modified Drug Effects Questionnaire (DEQ)
To assess the effect of TP on subjective drug effects compared to comparator. This non-validated questionnaire consists of 4 questions scored from 0 to 100, that assesses the participants subjective experience after consuming the TP.
Time frame
Days 1 and 14 of each treatment period2
Overall Well Being, Health, and Pain
To assess the effect of TP on overall well-being, health, and pain compared to comparator. This non-validated questionnaire consists of 4 questions scored from 0 to 100, that assesses overall quality of life with questions specifically on physical health and pain. Higher scores indicate better overall well-being, health, and pain.
Time frame
Pre-dose Day 1 to Pre-dose Days 7 and 14 of each treatment period3
Ecological Momentary Assessment (EMA) Survey
To assess the effect of TP on mood compared to comparator. A non-validated questionnaire consisting of 13 questions assessing the participants emotional and mental/physical states they are feeling "right now." This questionnaire uses bipolar visual analogue scales in which participants how they feel "right now" on lines between two opposite feelings or physical sensations.
Time frame
Days 2, 4, 6, 8, 10, 12, and 14 of each treatment period4
Study Product Perception & Attitude Survey
To assess the effect of TP on study product perceptions and attitudes compared to comparator. A non-validated questionnaire consisting of multiple items assessing participants' subjective experiences with the study product, including effects on daily functioning, energy, sleep, mood, mild stress/anxiety, focus, mild pain, muscle recovery, tolerability, and product quality. Items are scored on a 5#point Likert scale ranging from "Strongly Disagree" to "Strongly Agree." Higher scores indicate more favorable perceptions of the study product (except for the side effects item, where higher scores indicate greater perceived side effects).
Time frame
Days 7 and 14 of each treatment periodSponsors and contacts
Click on the lead sponsor to view all of their trials.
Botanic Tonics, LLC
Lead sponsor
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Collaborator
Source ClinicalTrials.gov