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Cannabinoid
Cannabidiol extract for Epilepsy
Phase < 1
Waitlist Available
Led By Bill Gurley, Ph. D.
Research Sponsored by University of Mississippi, Oxford
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Normal, healthy adults aged 21 to 55 years
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-72 hours
Awards & highlights
Study Summary
This trial will study how CBD affects the body after a single dose of CBDE, with the goal of extending to multiple doses in the future.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0-72 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-72 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Plasma concentration of minor phytocannabinoids, and metabolites following single dose administration of Cannabis extract (CBDE) (at 2.5 mg/kg cannabidiol (CBD).
Urine concentration of minor phytocannabinoids, and metabolites following single dose administration of Cannabis extract (CBDE) (at 2.5 mg/kg cannabidiol (CBD).
Secondary outcome measures
Area-under-the-concentration-time profiles (AUC), and area-under-the moment curve (AUMC), for CBD (cannabidiol) , up to 72 hours after Cannabis extract administration.
Clearance (Cl/F) up to 72 hours after Cannabis extract administration.
Maximum serum concentration (Cmax), up to 72 hours after Cannabis extract administration.
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Cannabidiol extractExperimental Treatment1 Intervention
10 healthy subjects (5 female, 5 male), will be enrolled into the study. Each subject will receive a single CBDE dose delivering 2.5 mg/kg CBD, after consumption of a standardized meal.
Nine (9mL) of blood for PK analysis, at each of the following timepoints: 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hours after the study drug administration.
Urine will be collected at the following timepoints: Predose, 0-4 hrs, 4-8 hrs, 8-12 hrs, 12-24 hrs, 24-36 hrs, 36-48 hrs, and 48-72 hrs for PK analysis
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Who is running the clinical trial?
University of Mississippi, OxfordLead Sponsor
11 Previous Clinical Trials
982 Total Patients Enrolled
Bill Gurley, Ph. D.Principal InvestigatorPrincipal Scientist, National Center for Natural Products Research
Frequently Asked Questions
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