Effects of Feel Free® Classic Tonic on Stress and Pharmacokinetics in Healthy Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-55
SponsorBotanic Tonics, LLC
About this trial
This study is being conducted to assess the effects of the Feel Free® Classic Tonic on stress in healthy adults. The goal is to see whether the tonic can help reduce self-perceived and physiological stress and provide information on how its ingredients are processed in the body.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults who are between 21 - 55 years of age (inclusive) at screening.
Have self-reported stress at screening and baseline scoring 14 - 26 (inclusive) on the PSS-10.
In good general health (no uncontrolled diseases or conditions) as deemed by the investigator and is able to consume the study product.
Not currently using, defined as ≤ 3 uses in the past 3 months prior to Baseline, any nicotine containing products (patches, gums, vapes etc.), kava products, and/or kratom products, and willing to abstain starting 14 days prior to Baseline 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 9 Screening or Baseline visits, a positive urine cotinine test at the Screening or Baseline visits, or a positive breath alcohol test at Baseline visit.
Have abnormal RR or SpO2 measurements at Screening or Baseline at the discretion of the investigator.
Trial design
Design model
Parallel
Treatments tested in this trial
Placebo
Other interventionPlacebo
Kava and Kratom Herbal Supplement
Other interventionFeel Free Classic Tonic Dose 1 (TP1)
Kava and Kratom Herbal Supplement
Other interventionFeel Free Classic Tonic Dose 2 (TP2 - Half Strength)
Treatment groups
165 Participants
are divided into 3 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: Feel Free Classic Tonic Dose 1Experimental treatment 1 intervention
Group C: Feel Free Classic Tonic Dose 2 (half strength)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Perceived Stress Scale-10 (PSS-10) Score
Change in PSS-10 score from baseline to Day 29 to assess the effect of the test product on self-perceived stress. Items are scored on a 5-point Likert scale ranging from 0 ('Never') to 4 ('Very Often'). Higher scores indicate higher perceived stress levels.
Time frame
Baseline (Day 1) to Day 29Secondary outcomes
1
Change in State-Trait Anxiety Inventory - State (STAI-S) - Single Dose
Change in STAI-S score from pre-dose to post-dose (pre-Trier Social Stress Test - Arithmetic \[pre-TSST-A\]) on Day 1 after a single dose. The scale assesses how participants feel "right-now". It measures subjective and temporary fluctuations in feelings associated with anxiety. Items (e.g., "I worry too much over something that really doesn't matter", "I am content") are rated on a 4-point scale, such as from "Almost Never" to "Almost Always". Higher score to be a higher anxiety.
Time frame
Day 1 pre-dose to Day 1 post-dose (pre-TSST-A)2
Change in State-Trait Anxiety Inventory - State (STAI-S) During TSST-A (Trier Social Stress Test - Arithmetic) - Single Dose
Change in STAI-S score from pre-TSST-A to post-TSST-A at 0, 15, 25, and 55 minutes on Day 1. The scale assesses how participants feel "right-now". It measures subjective and temporary fluctuations in feelings associated with anxiety. Items (e.g., "I worry too much over something that really doesn't matter", "I am content") are rated on a 4-point scale, such as from "Almost Never" to "Almost Always". Higher score to be a worse outcome.
Time frame
Day 1 assessments at pre-TSST-A, and post-TSST-A at 0, 15, 25, 55 minutes3
Change in State-Trait Anxiety Inventory - State (STAI-S) - Multiple-Day Dosing
Change in STAI-S score from pre-dose to post-dose (pre-Trier Social Stress Test - Arithmetic \[pre-TSST-A\]) on Day 29 after a single dose. The scale assesses how participants feel "right-now". It measures subjective and temporary fluctuations in feelings associated with anxiety. Items (e.g., "I worry too much over something that really doesn't matter", "I am content") are rated on a 4-point scale, such as from "Almost Never" to "Almost Always". Higher score to be a worse outcome.
Time frame
Day 29 pre-dose to Day 29 pre-TSST-A4
Change in State-Trait Anxiety Inventory - State (STAI-S) During TSST-A (Trier Social Stress Test - Arithmetic) - Multiple-Day Dosing
Change in STAI-S score from pre-TSST-A to post-TSST-A at 0, 15, 25, and 55 minutes on Day 29. The scale assesses how participants feel "right-now". It measures subjective and temporary fluctuations in feelings associated with anxiety. Items (e.g., "I worry too much over something that really doesn't matter", "I am content") are rated on a 4-point scale, such as from "Almost Never" to "Almost Always". Higher score to be a worse outcome.
Time frame
Day 29 measurements at pre-TSST-A, and post-TSST-A at 0, 15, 25 and 55 minutes.Other outcomes
1
PK Profile of Mitragynine AUC0-8 (Single Dose)
Area under the plasma concentration (AUC) -time curve from 0 to 8 hours after a single dose.
Time frame
Day 1 (0-8 hours)2
PK Profile of Mitragynine AUC8-24 (Single Dose)
Area under the plasma concentration (AUC)-time curve from 8 to 24 hours after a single dose.
Time frame
Day 1-Day 2 (8-24 hours)3
PK Profile of Mitragynine AUC0-24 (Single Dose)
Area under the plasma concentration (AUC) -time curve from 0 to 24 hours after a single dose.
Time frame
Day 1-Day 2 (0-24 hours)4
PK Profile of Mitragynine AUC0-∞ (Single Dose)
Area under the plasma concentration (AUC) -time curve from 0 to infinity after a single dose.
Time frame
Day 1-Day 2 (0-24 hours)Sponsors 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