CBD for Healthy Subjects
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.12345Why 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.24567
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Baseline plasma sample collected to determine presence of cannabinoids
Treatment
Participants take Happy Lane CBD soft gels for 10 consecutive days
Follow-up
Participants receive a follow-up phone call to collect any adverse events
What Are the Treatments Tested in This Trial?
Interventions
- Happy Lane Hemp Extract/CBD Soft Gels
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Arkansas
Lead Sponsor
Citations
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.htmlCV 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 ...
Happy Lane Softgels - 25 mg - 60 ct | CV Sciences
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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.
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 ...
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