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Determination of Cannabinoid and Cannabinoid Metabolite Levels in Healthy Volunteers
Phase < 1
Waitlist Available
Led By Igor Koturbash, MD, PhD
Research Sponsored by University of Arkansas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 13 days
Awards & highlights
No Placebo-Only Group
Summary
This trial involves healthy adults taking CBD capsules over a short period to measure CBD levels in their blood. The goal is to understand how the body processes CBD. Participants must be between 18-45 years old and free from cannabinoid use for a while. Cannabidiol (CBD) has been studied in various formulations and dosages for its safety and tolerability in both healthy volunteers and patients with conditions like epilepsy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 13 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~13 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Amount of 11-OH-THC in plasma of healthy volunteers that have ingested hemp extract/CBD for 10 consecutive days using LCMS
Amount of CBD in plasma of healthy volunteers that have ingested hemp extract/CBD for 10 consecutive days using LCMS
Amount of CBD-OH in plasma of healthy volunteers that have ingested hemp extract/CBD for 10 consecutive days using LCMS
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: 50 mg/day dose of Happy Lane CBD (Larger Dose)Experimental Treatment1 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 Treatment1 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.
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Who is running the clinical trial?
University of ArkansasLead Sponsor
496 Previous Clinical Trials
150,664 Total Patients Enrolled
Igor Koturbash, MD, PhDPrincipal InvestigatorUniversity of Arkansas