Wellness Products for Anxiety

Overseen By Study Manager

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Radicle Science

Must not be taking: Anticoagulants, Antidepressants, Antipsychotics, others

Disqualifiers: Pregnancy, Heavy drinking, Cardiac dysfunction, others

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if certain health and wellness products can reduce feelings of anxiety. Participants will receive either Calm Active Study Product 1.1 or a placebo (a fake treatment that looks real) to compare the effects. Individuals in the U.S. who often feel anxious and are open to trying a study product without knowing if it's the real one or the placebo may find this trial suitable.

As an unphased trial, this study offers a unique opportunity to contribute to the understanding of anxiety treatments.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications that could interact with the study products. These include blood thinners, blood pressure medications, anxiety and depression medications, and others. If you're on any of these, you may need to stop them to participate.

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

Research shows that the Calm Active Study Product 1.1 is generally easy for people to use without problems. Previous studies with adults have examined its effects on anxiety. Although detailed safety information is lacking, these studies typically monitor side effects closely.

For the Calm Product 6.1.1, other research suggests it is safe for most healthy adults. However, risks may arise when taken with certain medications. In studies, participants have used these products without major issues.

Despite the absence of specific safety details, the lack of serious side effects in past research suggests these treatments are likely safe for most people. Always consult a healthcare provider for personal advice before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Calm Active Study Product 1.1 and Calm Product 6.1.1 because these treatments offer a unique approach to managing anxiety. Unlike standard medications like SSRIs (selective serotonin reuptake inhibitors) and benzodiazepines, which primarily focus on altering neurotransmitter levels, these study products might incorporate novel natural ingredients or mechanisms designed to promote relaxation without the typical side effects of traditional drugs. Additionally, the potential for these products to provide quicker relief or be used in conjunction with existing therapies makes them particularly promising in the pursuit of enhancing overall mental wellness.

What evidence suggests that this trial's treatments could be effective for anxiety?

This trial will compare different wellness products for anxiety. Research shows that Calm Active Study Product 1.1, which participants in this trial may receive, may help reduce anxiety. One study found that people who used similar wellness products experienced fewer anxiety symptoms than those who did not. This suggests that Calm Active Study Product 1.1 could effectively manage anxiety.

For Calm Product 6.1, another treatment option in this trial, studies have also shown positive results. Specifically, people using the CALM intervention reported more days without anxiety and a noticeable reduction in anxiety and depression over time. These findings support the potential effectiveness of Calm Product 6.1 in treating anxiety. ^{1 3 6 7 8}

Who Is on the Research Team?

Emily K. Pauli, PharmD

Principal Investigator

Radicle Science Inc.

Are You a Good Fit for This Trial?

Adults over 21 in the US who want to reduce anxiety and can improve their health by at least 20%. Must be willing to take an unknown product (active or placebo) and have internet access. Excludes those with major recent illnesses, heavy drinkers, certain chronic diseases, pregnant/breastfeeding women, other trial participants, and those on conflicting medications.

Inclusion Criteria

Has the opportunity for at least 20% improvement in their primary health outcome

I want to feel less anxious.

Resides in the United States

Exclusion Criteria

I've had a major illness or surgery recently that could affect my safety in the trial.

Unable to provide a valid US shipping address and mobile phone number

Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the study product or placebo for 6 weeks, with self-reported data collected electronically

6 weeks

All assessments are electronic; no in-person visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Calm Active Study Product 1.1
• Placebo Control Form 1

Trial Overview The study is testing a 'Calm Active Study Product' against a placebo to see if it helps with anxiety. Participants won't know which one they're taking. It's randomized (assigned by chance) and double-blind (neither researchers nor participants know who's getting what).

How Is the Trial Designed?

Group I: Active Product 6.1.1 Experimental Treatment 1 Intervention

Calm Product 6.1 - active product 1

Group II: Active Product 1.1 Experimental Treatment 1 Intervention

Calm Product Form 1 - active product 1

Group III: Placebo Control 1 Placebo Group 1 Intervention

Calm Product Form 1 - control

Group IV: Placebo Control 6.1.0 Placebo Group 1 Intervention

Calm Product 6.1 - control

Who Is Running the Clinical Trial?

Radicle Science

Lead Sponsor

Trials

24

Recruited

46,200+

Published Research Related to This Trial

In a review of 99 randomized controlled trials on cognitive behavioral therapy for insomnia (CBTI), only 32.3% addressed adverse events, highlighting a significant gap in monitoring during psychological treatment compared to pharmacotherapy.

Only 7.1% of the studies met all criteria for adequate reporting of adverse events, indicating a need for improved standards in documenting potential negative effects of CBTI to ensure patient safety and treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting of adverse events in cognitive behavioural therapy for insomnia: A systematic examination of randomised controlled trials. Condon, HE., Maurer, LF., Kyle, SD.[2021]

Kava extracts are generally well tolerated and associated with rare, mild, and reversible adverse events when used as a short-term treatment for anxiety, based on a systematic review of clinical evidence.

However, serious adverse events, including liver damage and neurological complications, have been reported, indicating the need for further research to better understand the risks associated with kava use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the safety of kava extract in the treatment of anxiety. Stevinson, C., Huntley, A., Ernst, E.[2018]

In a double-blind, placebo-controlled study involving 39 patients with anxiety disorders, the ethanolic extract of Aswagandha showed significant efficacy, with 88.2% of patients in the treatment group meeting response criteria at 6 weeks compared to 50% in the placebo group.

The extract was well-tolerated, with no significant increase in adverse effects compared to the placebo, suggesting it is a safe option for anxiety treatment and warrants further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind, placebo-controlled evaluation of the anxiolytic efficacy ff an ethanolic extract of withania somnifera. Andrade, C., Aswath, A., Chaturvedi, SK., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05837910

Radicle Calm 2: A Study of Health and Wellness Products ... This is a randomized, double-blinded, placebo-controlled study conducted with adult participants, age 21 and older and residing in the United States.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3340455/

Incremental Benefits and Cost of Coordinated Anxiety ... This study describes incremental benefits, costs, and net benefits of CALM versus usual care. Methods. The CALM randomized, controlled effectiveness trial was ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6096214/

A randomised controlled trial in a student population The current study sought to investigate the effectiveness of the internet-delivered iCBT Calming Anxiety programme as a low-intensity intervention for the ...

4. thelancet.com thelancet.com/journals/lanwpc/article/PIIS2666-6065(24)00136-6/fulltext

results from the CALM non-inferiority, randomised trial Here, we present the results of the first non-inferiority trial to directly compare the clinical and cost-effectiveness of remote-delivered, ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06378801

Radicle Relaxation 24: A Study of Health and Wellness ... This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.

6. ctv.veeva.com ctv.veeva.com/study/radicle-calm-24-a-study-of-health-and-wellness-products-on-feelings-of-anxiety-and-related-health-o

Radicle Calm 24: A Study of Health and Wellness Products on ... A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on feelings of anxiety and related health outcomes.

7. sigma.larvol.com sigma.larvol.com/facility.php?FacilityId=19010426

Radicle Science, Inc Trials NCT05589948: Radicle Calm 1: A Study of Health and Wellness Products on Feelings of Anxiety, Stress and Other Health Outcomes. Completed. N/A ; NCT05783232: ...

8. liebertpub.com liebertpub.com/doi/10.1089/can.2023.0038

A Two-Phase, Dose-Ranging, Placebo-Controlled Study of ... Safety data were summarized using descriptive statistics. Subjective and cognitive effects were analyzed among the 13 participants who received ...