Health Products for Sleep Disorders

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 tests various health and wellness products to assess their impact on sleep and related health outcomes. Participants will use either an active product (Radicle Rest Active Study Product 1.1 or 2.1) or a placebo, without knowing which one they have, to ensure objective results. The trial seeks U.S. residents who wish to improve their sleep and are comfortable taking a product without knowing if it's active or a placebo. Those who experience sleep difficulties and are not currently facing major health issues or taking certain medications might be suitable for this study. As an unphased trial, it offers a unique opportunity to contribute to the understanding of sleep improvement products.

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, such as anticoagulants, antidepressants, and others listed in the exclusion criteria. 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 has shown that Radicle Rest products have undergone testing in earlier studies to ensure their safety for people. For Radicle Rest Active Study Product 1.1, studies found that a mix of plant-based ingredients with a small amount of THC (a compound found in cannabis) improved sleep, reduced anxiety, and enhanced overall well-being without major side effects. Participants generally tolerated it well.

Radicle Rest Active Study Product 2.1 underwent similar tests with adult participants in controlled environments. Although detailed safety information remains limited, these studies are designed to ensure participant safety.

Radicle Rest Active Study Product 4.1.1 also underwent similar trials. Results showed that participants tolerated the products well, with the main goal of improving sleep and related health outcomes. Again, no significant negative effects were reported.

While various studies have tested these products, they remain under research. Anyone interested in joining a clinical trial should discuss potential risks and benefits with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Radicle Rest Active Study Products 1.1 and 2.1 because they offer potential new ways to tackle sleep disorders. Unlike standard treatments like melatonin supplements or prescription sleep aids, these products might work by targeting different pathways in the brain that regulate sleep, which could lead to more effective or faster relief. Additionally, these treatments might have a unique formulation that reduces common side effects associated with traditional sleep medications, such as grogginess or dependence. This innovative approach could provide a refreshing alternative to those who haven't found success with current options.

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

Research shows that the treatments in this trial, Radicle Rest Active Products 1.1, 2.1, and 4.1.1, might improve sleep. These products contain a mix of plant-based ingredients with a small amount of THC, which has reduced sleep problems. Participants in previous studies reported better sleep, less anxiety, lower stress, and improved well-being. These results suggest the products could help with sleep issues. However, further research is needed to confirm these benefits across diverse populations. ^{1 2 3 5 6}

Who Is on the Research Team?

Emily K. Pauli, PharmD

Principal Investigator

Radicle Science Inc.

Are You a Good Fit for This Trial?

This trial is for individuals experiencing sleep disorders who are interested in testing health and wellness products designed to improve sleep. Specific eligibility details aren't provided, but typically participants must meet certain health conditions.

Inclusion Criteria

Resides in the United States

I am 21 years or older and understand my participation will involve sex-specific aspects.

I could see at least a 20% improvement in my main health issue.

Exclusion Criteria

Lack of reliable daily access to the internet

Reports current enrollment in another clinical trial

I've had a major illness or surgery in the last 3 months that could be risky for my health.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive the study product or placebo for 6 weeks to assess impact on sleep and related health outcomes

6 weeks

All assessments are electronic; no in-person visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Radicle Rest Active Study Product 1.1 Usage
• Radicle Rest Active Study Product 2.1 Usage

Trial Overview The study tests two different Radicle Rest active products against two placebo controls to see if they help with sleep issues. It's a randomized trial, meaning participants are assigned to one of the four groups by chance and neither they nor the researchers know which group they're in (double-blind).

How Is the Trial Designed?

Group I: Placebo Control 4.1.0 Experimental Treatment 1 Intervention

Rest Product 4 - control

Group II: Active Product 4.1.1 Experimental Treatment 1 Intervention

Rest Product 4 - active product 1

Group III: Active Product 2.1 Experimental Treatment 1 Intervention

Rest Product Form 2 - active product 1

Group IV: Active Product 1.1 Experimental Treatment 1 Intervention

Rest Product Form 1 - active product 1

Group V: Placebo Control 2 Placebo Group 1 Intervention

Rest Product Form 2 - control

Group VI: Placebo Control 1 Placebo Group 1 Intervention

Rest Product Form 1 - control

Who Is Running the Clinical Trial?

Radicle Science

Lead Sponsor

Trials

24

Recruited

46,200+

Published Research Related to This Trial

Melatonin receptor agonists have the lowest rate of adverse events (43.1 per 1000), while non-benzodiazepine benzodiazepine receptor agonists have the highest (255.0 per 1000), indicating a significant difference in safety profiles among insomnia medications.

Benzodiazepines showed the highest efficacy in improving sleep outcomes with an effect size of 1.94, while melatonin receptor agonists had the lowest efficacy (0.109), suggesting that histamine antagonists may offer the best risk-benefit ratio for treating insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative short-term safety and efficacy of hypnotics: A quantitative risk-benefit analysis. Cheung, JMY., Scott, H., Muench, A., et al.[2023]

The use of herbal preparations for sleep issues among adults in the U.S. has significantly increased from 2.5% to 12.4% over the past decade, highlighting a growing interest in alternative remedies.

Health care professionals need to be informed about the pharmacological properties of commonly used herbal sleep aids and wake-promoting products to better educate their patients on safe and effective use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Herbal remedies: efficacy in controlling sleepiness and promoting sleep. Merritt, SL., Gyllenhaal, C., Peterson, SD., et al.[2015]

Patients who received education on using sleep-enhancing tools (like eye masks and white noise machines) experienced a significant reduction in fatigue compared to those who only received general sleep information, indicating that targeted education can improve patient outcomes.

While the education intervention showed benefits in fatigue, it did not significantly affect other sleep-related issues or the length of hospital stay, suggesting that while helpful, the approach may need to be part of a broader strategy for improving overall patient well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Sleep Tool Education During Hospitalization: A Randomized Controlled Trial. Farrehi, PM., Clore, KR., Scott, JR., et al.[2019]

In a 6-month open-label extension study involving 360 adults with primary insomnia, eszopiclone significantly improved sleep quality, reduced sleep latency, and enhanced daytime functioning without evidence of tolerance.

Patients who switched from placebo to eszopiclone maintained and even further improved their sleep and daytime function over the 6-month period, with the treatment being well tolerated, aside from a mild side effect of unpleasant taste.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of the efficacy and safety of eszopiclone over 12 months in patients with chronic primary insomnia. Roth, T., Walsh, JK., Krystal, A., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06347744

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

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05511818

NCT05511818 | Radicle Rest: A Study of Cannabinoids on ... This is a randomized, blinded, placebo-controlled study conducted with up to 300 adult participants per study arm, age 21 and older and residing in the ...

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

Radicle Science, Inc Trials NCT05511818: Radicle Rest: A Study of Cannabinoids on Sleep and Health Outcomes. Completed. N/A ; NCT05589948: Radicle Calm 1: A Study of Health and Wellness ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10490534/

A Randomized, Double-Blind, Placebo-Controlled ... A botanical blend containing a low concentration of THC improved sleep disturbance, anxiety, stress, and well-being in healthy individuals that reported better ...

5. medrxiv.org medrxiv.org/content/10.1101/2023.07.02.23292135v2

A randomized, double-blind, placebo-controlled ... A botanical blend containing a low concentration of THC improved sleep disturbance, anxiety, stress, and well-being in healthy individuals.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37686820/

A Randomized, Double-Blind, Placebo-Controlled ... A botanical blend containing a low concentration of THC improved sleep disturbance, anxiety, stress, and well-being in healthy individuals.