Clinical trial Recruiting at 1 site Interventional Ages 21 to 55

Feel Free Classic Tonic to reduce stress in healthy adults

Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effects of Feel Free® Classic Tonic on Self-Perceived Stress and Pharmacokinetic Profile in Healthy Adults

Run by Botanic Tonics, LLC · NCT07469527 · Data updated 2026-11-12

This will test whether the Feel Free Classic Tonic (containing kava and kratom) can reduce how stressed healthy adults aged 21–55 feel and change physiological stress markers.

More Anxiety trials

Quick facts

Study typeInterventional
Ages21 Years to 55 Years
SexAll
Enrollment165 (estimated)
SponsorBotanic Tonics, LLC
Industry-sponsored
Locations1 site (Guelph, Ontario)
StatusRecruiting
StartedMarch 7, 2026
Main results expectedSeptember 30, 2026
Study endsOctober 14, 2026
Registry record updatedMay 1, 2026
Trial IDNCT07469527 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Healthy adults 21–55 with self-reported mild-to-moderate stress (PSS-10 14–26), BMI 18.5–29.9 kg/m2, willing to abstain from kava/kratom/nicotine and follow study restrictions are the ideal candidates.

Probably not a fit

People with severe anxiety or other uncontrolled medical or psychiatric conditions, those outside the age or BMI ranges, regular kava/kratom users, pregnant or breastfeeding people, or those unwilling to follow visit requirements are unlikely to benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, parallel, three-arm, placebo-controlled study testing two dose levels of the Feel Free Classic Tonic in healthy adults. Participants who report mild-to-moderate stress (PSS-10 score 14–26) and meet BMI and other eligibility criteria are randomized to placebo or one of two active doses. The trial includes a pharmacokinetic sub-study to measure absorption and processing of the tonic's botanical components. Participants must abstain from regular kava, kratom, and nicotine use and attend in-person visits at the study site in Guelph, Ontario.

Why it matters

Potential benefit: If successful, the tonic could offer a non-prescription botanical option to help reduce subjective and physiological stress.

How similar studies have gone: Kava has shown modest benefits for anxiety in prior randomized trials while kratom is less studied and has safety concerns, so this specific kava–kratom combination is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Adults who are between 21 - 55 years of age (inclusive) at screening.
2. Have self-reported stress at screening and baseline scoring 14 - 26 (inclusive) on the PSS-10.
3. In good general health (no uncontrolled diseases or conditions) as deemed by the investigator and is able to consume the study product.
4. 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.
5. Have a BMI range of 18.5 - 29.9 kg/m2 at screening and baseline.
6. Agree to follow the restrictions on concomitant treatments.
7. Agree to follow the restrictions on lifestyle.
8. Have maintained consistent dietary habits, including supplement intake, and lifestyle for the last 3 months before screening and agree to maintain them throughout the study.
9. Agree to use acceptable contraceptive methods.
10. Agree to abstain from alcohol consumption for the entire duration of the study.
11. Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.
12. For Sub-Study participants only:

    * Must have suitable veins for repeated venipuncture.
    * Willing and able to attend video conference calls with study coordinators.

Exclusion Criteria:

1. Individuals who are lactating, planning to become pregnant during the study, or pregnant as confirmed by a positive pregnancy test during study visits.
2. Have a known sensitivity, intolerability, or allergy to any of the study products, their excipients, or rescue medication.
3. 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.
4. Have abnormal RR or SpO2 measurements at Screening or Baseline at the discretion of the investigator.
5. Screening laboratory results showing liver enzyme levels \[Alanine Transaminase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP), Gamma-Glutamyl Transferase (GGT), total bilirubin\] ≥ 2 times the upper limit of normal, or any other clinically significant abnormal safety laboratory values as per the Investigator's discretion.
6. Is currently enrolled in another clinical trial or has received/used an investigational product in another research study within 28 days before baseline.
7. Individuals with an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea).
8. Have Type I/Type II diabetes or thyroid disease (thyroid function to be assessed by TSH, T3, and T4 levels at Screening visit).
9. High BP at the Screening or Baseline Visit (≥140 systolic or ≥90 diastolic mmHg)
10. Have low BP (\<90 systolic or \<60 diastolic mmHg) at Baseline unless deemed clinically insignificant by the investigator and the participant is asymptomatic.
11. Have a history of heart disease, blood clotting disorders, renal or hepatic impairment/disease, or liver injury.
12. Have known genetic polymorphisms of CYP450, CYP3A4, CYP2D6, and/or CYP1A2 enzymes.
13. Individuals with active asthma or have experienced an asthma attack in the last 5 years.
14. Are receiving treatments for or have been hospitalized in the last 12 months for psychiatric disorders (e.g., depression, bipolar disorder, schizophrenia, etc.).
15. Have a history of cancer (except localized skin cancer without metastases or in situ cervical cancer) with recovery occurring within 5 years before the screening visit.
16. Reports significant blood loss or blood donation totaling between 101 mL to 449 mL of blood within 30 days before baseline or a blood donation of more than 450 mL within 56 days before baseline.
17. Reports donating plasma (e.g., plasmapheresis) within 15 days before baseline.
18. Major surgery in 3 months before screening or planned major surgery during the study.
19. History of alcohol or substance abuse (e.g., opioids, kratom) (including having been hospitalized for such an in-patient or out-patient intervention program).
20. Evidence of addictive tendency as indicated by an LDQ score ≥21.
21. Use of anxiolytic or sleep aids (natural health products or drugs) in the 4 weeks before baseline.
22. Currently consumes more than two (2) standard alcoholic beverages per day on average for 4 weeks.

    Note: A standard alcoholic beverage is defined as 12 ounces of beer, 5 ounces of wine, or 1.5 ounces of liquor.
23. Excessive caffeine intake, defined as habitual consumption of \>500 mg per day.
24. Any other medical conditions or use of medications/supplements/therapies that, in the opinion of the investigator, may adversely affect the participant's ability to complete the study or its measures, pose a significant risk to the participant or compromise the quality of study data.

Where it's running

  • ApexTrials
    Guelph, Ontario, Canada
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.