Safety and efficacy in healthy adults Not Applicable
Conditions
Interventions
There were two study products, the placebo and the test product (Feel Free Tonic). The test product (Feel Free Tonic) was provided in three dosage levels: low dose (15 ml per day), mid dose (30 ml per
Sponsors
Botanic Tonics, LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults who are between 21 – 55 years of age (inclusive). 2. In good general health (no uncontrolled diseases or conditions) as deemed by the investigator and is able to consume the study product (consume approx. 15 mL/0.5 oz of either study product). 3. Naïve to kratom use or occasional kratom use (no more than once within 28 days prior to Visit 2). 4. Non-smoker (including nicotine vaping) and have not used any nicotine products (patches, gums etc.) for >3 months prior to Visit 2. Non-smoker is defined as someone who does not habitually/regularly use products containing nicotine. 5. Have a body mass index (BMI) range of 18.5 – 29.9 kg/m2 at Visit 2. 6. Individuals with childbearing potential must agree to practice an acceptable form of birth control for a certain timeframe prior to the first dose of the study product and throughout the study, including: 6.1. Use for at least 3 months prior to the first dose of study product: hormonal contraceptives including oral contraceptives, hormone birth control patch (e.g., Ortho Evra), vaginal contraceptive ring (e.g., NuvaRing), injectable contraceptives (e.g., Depo-Provera, Lunelle), hormone implant (e.g., Norplant System), or intrauterine devices (e.g., Mirena); or 6.2. Use for at least 1 month prior to the first dose of study product: double-barrier method, non-hormonal intrauterine devices (i.e., copper), or complete abstinence from sexual intercourse that can result in pregnancy; or 6.3. Vasectomy of partner at least 6 months prior to the first dose of study product. Individuals with the potential to impregnate others must agree to use condoms or other acceptable methods to prevent pregnancy throughout the study. Complete abstinence from sexual intercourse that can result in pregnancy is also acceptable. 7. Agree to refrain from treatments and other items listed in Section 6.5 in the defined timeframe. 8. Agree not to donate blood until 3 months after the study completion. 9. Must have suitable veins for repeated venipuncture. 10. Have maintained consistent dietary habits (including supplement intake) and lifestyle for the last 3 months prior to screening and agree to maintain dietary habits and lifestyle throughout 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.
Exclusion criteria
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 8 3 or positive breath alcohol test. 4. Have abnormal RR or SpO2 measurements at the discretion of the investigator. 5. Is currently enrolled in another clinical trial or has received/used an investigational product in another research study within 28 days prior to Visit 2 for either the Main study or the Sub-study (except for participants who are willing to participate in both portions of the study, they may be screened for eligibility for the Main study after a minimum of a 2-week washout from the last visit of the Sub-study). 6. 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). 7. Have Type I/Type II diabetes, high BP at visit 2 (=140 systolic or =90 diastolic mmHg), or thyroid disease. 8. Have a history of heart disease, blood clotting disorders, renal or hepatic impairment/disease. 9. Have known genetic polymorphisms of CYP450, CYP3A4, CYP2D6, and/or CYP1A2 enzymes. 10. Individuals with active asthma or have experienced an asthma attack in the last 5 years. 11. Are receiving treatments for or have been hospitalized in the last 12 months for psychiatric disorders (e.g., depression, bipolar disorder, schizophrenia, etc.). 12. Have a history of cancer (except localized skin cancer without metastases or in situ cervical cancer) with recovery occurring within 5 years prior to the screening visit. 13. Reports significant blood loss or blood donation totaling between 101 mL to 449 mL of blood within 30 days prior to Visit 2 (either study) or a blood donation of more than 450 mL within 56 days prior to Visit 2 (either study). 14. Reports donating plasma (e.g., plasmapheresis) within 15 days prior to Visit 2 (either study). 15. Major surgery in 3 months prior to screening or planned major surgery during the study. 16. History of alcohol or substance abuse in the 12 months prior to screening (including having been hospitalized for such an in-patient or out-patient intervention program). 17. Evidence of addictive tendency as indicated by an LDQ score =21. 18. Currently consumes more than 2 standard alcoholic beverages a day. Note: A standard alcoholic beverage is defined as 12 ounces of beer, 5 ounces of wine, or 1.5 ounces of liquor. 19. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognition is measured using the Computerized Cognitive Testing Battery at baseline and Day 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mood and mental health is measured using Mood and Mental Health Survey scores at baseline and Day 6 2. Mitragynine and 7-hydroxymitragynine pharmacokinetic profiles are measured using plasma concentrations at baseline, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, and 72.0 hours post-dose to determine maximum concentration (Cmax), time to peak concentration (Tmax), half-life (T1/2) and total systemic exposure (measured by area under curve (AUC) from 0-72 hours) 3. Kavain and dihydrokavain pharmacokinetic profiles are measured using plasma concentrations at baseline, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, and 72.0 hours post-dose to determine maximum concentration (Cmax), time to peak concentration (Tmax), half-life (T1/2) and total systemic exposure (measured by area under curve (AUC) from 0-72 hours) 4. The accumulation of mitragynine, 7-hydroxymitragynine, kavain, and dihydrokavain are measured using trough pre-dose plasma concentrations at baseline, Day 2, Day 3, Day 4, Day 5, and Day 6 5. Safety is assessed using: 5.1. Vitals (heart rate [HR] and blood pressure [BP]) at baseline, Day 7 and Day 9 5.2. Laboratory blood tests at baseline, Day 6, Day 7, and Day 9 unless otherwise specified 5.3. Hematology: hemoglobin, hematocrit, red blood cells (RBC), red cell distribution width (RDW), and RBC indices, which consist of mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH) and mean corpuscular hemoglobin concentration (MCHC). Additionally, white blood cells (WBC) and their differentials (neutrophils, eosinophils, basophils, lymphocytes, and monocytes) are measured, along with mean platelet volume (MPV), platelet count, and blood smear 5.4. Clinical chemistry: urea, creatinine with estimated glomerular filtration rate (eGFR), total bilirubin, alkaline phosphatase, aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyl transferase (GGT), albumin, random glucose (baseline only), fasting glucose ( | — |
Countries
Canada
Contacts
Public ContactLois Lin
Outcome results
None listed