165 Participants NeededMy employer runs this trial

Feel Free® Classic Tonic for Stress

AA
SR
Overseen ByStephanie Recker

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Feel Free® Classic Tonic can reduce stress in healthy adults. Researchers seek to understand how the tonic's ingredients affect stress levels and how the body processes them. Participants will receive either a placebo, a half-strength tonic, or a full-strength tonic. This trial may suit individuals who have felt stressed recently but are generally healthy, do not use nicotine, kava, or kratom products, and abstain from alcohol during the study. As an unphased trial, it offers a unique opportunity to contribute to scientific understanding and potentially discover new ways to manage stress.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop taking your current medications. However, you must agree to follow restrictions on treatments and lifestyle, and any medications or supplements that might affect the study could be restricted by the investigator.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Feel Free® Classic Tonic, containing kava and kratom, is generally well tolerated according to early data. Traditionally, kava and kratom are used to aid relaxation and mood. However, concerns exist regarding the tonic's ingredients, which have been linked to risks such as dependency, withdrawal symptoms, and liver damage. Some studies suggest that in higher amounts, these substances can act like opioids, potentially leading to serious health risks. Although marketed as safe, prospective trial participants should be aware of these potential issues.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about Feel Free® Classic Tonic for stress because it uses a unique combination of natural ingredients: Kava root extract and Kratom leaf powder. Unlike standard stress treatments like SSRIs or benzodiazepines, which primarily alter neurotransmitter levels, Feel Free® offers a more natural approach, potentially reducing side effects associated with synthetic medications. Additionally, the tonic comes in two strengths, allowing for a customizable experience that could cater to different levels of stress and individual patient needs.

What evidence suggests that Feel Free® Classic Tonic might be an effective treatment for stress?

Research has shown that Feel Free® Classic Tonic, which contains kava and kratom, may enhance mood and cognitive abilities. Kava is known for its relaxing effects, while kratom can boost energy in small amounts and act as a strong painkiller in larger doses. In this trial, participants will receive either Feel Free® Classic Tonic at full strength, half strength, or a placebo. An early study found that the tonic improved mood and thinking skills in healthy adults compared to a placebo. However, concerns exist about potential health risks and addiction associated with kratom. Overall, initial findings suggest the tonic might help with stress, but caution is advised due to possible side effects.12678

Who Is on the Research Team?

RA

Ramsey Atallah

Principal Investigator

Botanic Tonics

Are You a Good Fit for This Trial?

This trial is for adults aged 21-55 who are generally healthy, have moderate self-reported stress, a BMI between 18.5 and 29.9, do not regularly use nicotine, kava, or kratom products, and can follow lifestyle restrictions like avoiding alcohol during the study.

Inclusion Criteria

6. Agree to follow the restrictions on concomitant treatments.
7. Agree to follow the restrictions on lifestyle.
3. In good general health (no uncontrolled diseases or conditions) as deemed by the investigator and is able to consume the study product.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Feel Free® Classic Tonic or placebo to assess effects on stress and pharmacokinetics

4 weeks
Multiple visits for dosing and assessments

Pharmacokinetic Assessment

Pharmacokinetic sub-study to assess absorption and processing of tonic components

Day 1 to Day 2
Intensive sampling over 24 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week
Follow-up phone call

What Are the Treatments Tested in This Trial?

Interventions

  • Feel Free® Classic Tonic

Trial Overview

The study compares the effects of Feel Free® Classic Tonic (a supplement containing kava and kratom) to a placebo in reducing stress among healthy adults. It also looks at how the body processes these ingredients.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: Feel Free Classic Tonic Dose 2 (half strength)Experimental Treatment1 Intervention
Group II: Feel Free Classic Tonic Dose 1Experimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Botanic Tonics, LLC

Lead Sponsor

Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

Collaborator

Trials
40
Recruited
2,400+

Citations

Effects of Feel Free® Classic Tonic on Stress and ...

The tonic contains kava and kratom, botanicals traditionally used for relaxation and mood support, and early data suggest it is generally well tolerated.

Effects of Feel Free® Classic Tonic on Stress and ...

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 ...

Clinically characterizing adults who use kava or kratom - PMC

However, among kratom-naïve adults, kratom leaf and mitragynine extract have not produced clear indicators of intoxication or drug demand, ...

Effects of a liquid blend containing kava and kratom in ...

The test product, Feel Free Tonic, at the dosages investigated, improves cognitive function and mood in healthy adults, compared to placebo. It also ...

Understanding Kratom-Containing Feel Free and Its Risks

The combination and concentration of these botanicals in the Feel Free Classic tonic can lead to potent effects and potential health risks, ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39807458/

The Safety of Multiple-Dose Liquid Blend Containing Kava ...

This study investigates the safety of three different daily dosages of a liquid blend containing kava and kratom (Feel Free® Classic Tonic {FFCT}) ...

"Feel Free" Drinks: The Hidden Risk

"Feel Free" drinks are available over the counter as safe and marketed as non-addictive. Unpack the hidden dangers & how we can help.

Is the Feel Free Drink Safe? Kava, Kratom & Addiction Risks

The Feel Free drink with kava and kratom is marketed as natural, but is it safe? Learn the risks, addiction concerns, and what people in ...