Clinical Trial

Pharmacokinetic Evaluation of a Natural CBD Extract

Completed
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Summary
The present cross-over study investigated whether cannabidiol (CBD) or its metabolites and delta-9-tetrahydrocannabinol (THC) can be detected in the systemic circulation following a single topical application of a natural hemp extract-based cosmetic (NHEC) consisting of CBD and medium chain triglycerides (capric, caprylic triglycerides or medium chain triglycerides (MCT)) derived from coconut oil. Since consumers can consider hemp/CBD oil as a nutritional product or dietary supplement, it can be ingested by consumers. Therefore, we analyzed the concentrations of CBD, THC, and their metabolites in systemic circulation after oral NHEC administration. Additionally, we tested whether a single topical or oral use of the NHEC would lead to detectable levels of THC in the urine samples using Easy@Home THC detection strips. This study has no intent to treat or prevent any diseases or conditions. In this study, volunteer participants were assigned to one of two study groups: Cohort A (oral administration) or Cohort B (topical administration). After completing the study in the first assigned Cohort, participants had a 15-day washout period before beginning the study in the next Cohort.
Trial Details
NCT Number NCT07359976
Lead Sponsor University of Utah
Conditions Pharmacokinetics of CBD Extract, Oral and Topical Administrations
Enrollment 20 participants
Start Date 2021-01-04
Primary Completion 2024-11-07 (estimated)
Study Completion 2025-01-16 (estimated)
Updated on ClinicalTrials.gov 2026-01-22