CBD for Healthy Subjects

Overseen By Igor Koturbash, MD, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Arkansas

Must not be taking: Cannabinoids, Prescription medications

Disqualifiers: Cannabinoid use, Serious illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 10 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how the body processes cannabinoids, compounds found in cannabis, by measuring blood levels after participants take CBD (cannabidiol) soft gels. Participants will try two different doses of Happy Lane Hemp Extract/CBD Soft Gels to assess how each dose affects cannabinoid levels in the blood. The trial seeks individuals who have not recently used cannabinoids and are not taking any medications or supplements. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants an opportunity to contribute to groundbreaking research on cannabinoids.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescription or over-the-counter medications and supplements during the study and in the 24 hours before you start the study.

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

Research has shown that CBD is generally safe when taken orally in small amounts for a short period. Studies have found that people can tolerate up to 200 milligrams a day without issues. The trial for Happy Lane CBD Soft Gels tests either 25 mg or 50 mg per day, significantly less than the 200 mg studied, potentially resulting in fewer side effects.

CBD may cause mild side effects in some individuals, such as fatigue, appetite changes, and digestive issues, though these are usually not serious. The Happy Lane Soft Gels contain less than 0.00% THC, the component of cannabis responsible for the "high."

Overall, research suggests that the doses used in this trial are likely well-tolerated by most people. However, as this is an early-stage trial, unknown safety concerns may exist. Participants should consult a healthcare provider before starting new supplements. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they explore the potential of CBD, a compound derived from hemp, as a unique approach to managing various conditions. Unlike traditional medications, which often involve synthetic compounds, Happy Lane CBD soft gels use natural hemp extract to deliver cannabinoids. This method offers a new way to study how CBD is metabolized in the body, potentially leading to more personalized and effective uses of cannabinoids. Additionally, the study's two dosage options (25 mg/day and 50 mg/day) allow researchers to assess different levels of efficacy and safety, which could pave the way for more tailored treatment plans.

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

Research has shown that CBD (cannabidiol) may aid in pain relief and improve sleep by interacting with the body's natural systems. Some studies have found that CBD can also reduce anxiety in certain situations. In this trial, participants will receive either a 25 mg/day or a 50 mg/day dose of Happy Lane CBD soft gels, made from hemp, as a safe and effective option. Although this trial involves healthy volunteers, scientists are interested in CBD for its potential health benefits. CBD products like Happy Lane are designed to offer benefits without the "high" caused by THC, the component of cannabis that affects the mind. ^{2 4 5 6 7}

Who Is on the Research Team?

Igor Koturbash, MD, PhD

Principal Investigator

University of Arkansas

Are You a Good Fit for This Trial?

Inclusion Criteria

Attestation not to use other cannabinoid-containing product(s) throughout the duration of the study

Attestation not to use prescription or over the counter medication(s) and/or supplements throughout the duration of the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline Assessment

Baseline plasma sample collected to determine presence of cannabinoids

1 day

1 visit (in-person)

Treatment

Participants take Happy Lane CBD soft gels for 10 consecutive days

10 days

1 visit (in-person) at the end of treatment

Follow-up

Participants receive a follow-up phone call to collect any adverse events

2 days

1 call (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Happy Lane Hemp Extract/CBD Soft Gels

How Is the Trial Designed?

Group I: 50 mg/day dose of Happy Lane CBD (Larger Dose) Experimental Treatment 1 Intervention

Two 25 mg Happy Lane CBD gel capsules per day (50 mg/day total dose) for 10 consecutive days at approximately the same time of day (±1 hour) on each of these days. Both capsules will be taken at the same time as each other.

Group II: 25 mg/day dose of Happy Lane CBD (Lower Dose) Experimental Treatment 1 Intervention

One 25 mg Happy Lane CBD gel capsule per day (25 mg/day total dose) for 10 consecutive days at approximately the same time of day (±1 hour) on each of these days.

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+

Citations

1. cvsciences.com cvsciences.com/happy-lane-coa-softgel-60ct.html

Happy Lane Softgel Capsule Datasheet - 25mg 60ct For more information on Happy Lane Softgel Capules, review our datasheet and test results.

2. globenewswire.com globenewswire.com/news-release/2020/08/05/2073312/0/en/CV-Sciences-Inc-Announces-Launch-of-Happy-Lane-CBD-Product-Line.html

CV Sciences, Inc. Announces Launch of Happy Lane™ CBD ... hemp derived CBD that has been verified to be safe and effective. Happy Lane™ allows us to expand our sales channels to bring the CV ...

3. hempproductsconnect.com hempproductsconnect.com/happy-lane-softgels-25-mg-60-ct-prod1262092.html

Happy Lane Softgels - 25 mg - 60 ct | CV Sciences Designed for a hip and active demographic, easy to swallow Happy Lane CBD Softgels from CV Sciences provide the advantages of daily CBD with less than 0.00% THC ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2667276624001215

Effectiveness and safety of cannabis-based products for ... Although some results denote that cannabinoids may offer pain relief and improve sleep in patients with FMS, mainly through endocannabinoid system modulation; ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7880228/

Therapeutic Efficacy of Cannabidiol (CBD): A Review of the ... Overall, evidence regarding the therapeutic efficacy of CBD to treat anxiety is mixed, with some studies showing that CBD acutely reduces self- ...

6. api.ods.od.nih.gov api.ods.od.nih.gov/staging-s3/pdf/276581.pdf

cbd softgels Suggested Use*: Adults: Take 1 or more softgels 30 minutes before bed. Store away from humidity, heat and light. WARNING: CONSULT YOUR HEALTHCARE.

7. webmd.com webmd.com/cannabinoids/cbd-safety-tips-side-effects

Cannabidiol (CBD): Safety and Side Effects Research suggests that CBD is safe when taken orally in small doses for a short period of time. Studies have shown that taking up to 200 milligrams daily for ...