Pharmacokinetic Evaluation of a Natural CBD Extract

Utah System of Higher Education (USHE)

Status

Completed

Conditions

Pharmacokinetics of CBD Extract, Oral and Topical Administrations

Treatments

Dietary Supplement: CBD extract

Study type

Interventional

Funder types

Other

Identifiers

NCT07359976

10058347

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy adult volunteers (males and females, 18 - 50 years old) with a BMI 19-30. Subjects who were able to ingest or apply test products. The participants understood the requirements of the study.

Exclusion criteria

Individuals less than 18 years of age or over 50 years of age at enrollment;
Individuals previously participated in a research study involving administration of the investigational compound within one month prior to the current study;
Individuals who were using any recreational drug, specifically marijuana, in the past six months;
Individuals with a history of alcoholism;
Individuals who have conditions that might have possible interference with the study product absorption, distribution, metabolism, or excretion: previous surgery of the gastrointestinal tract, including removal of parts of the stomach, bowel, liver, gall bladder, pancreas or adjustable gastric band surgery, impaired glucose tolerance, diabetes mellitus, renal disease, edema, hepatic disorder.
Individuals who are pregnant or may become pregnant during studies
Individuals who are reporting any chronic diseases, such as mental disorders
The University of Utah faculty, students, and employees whom the investigators of this study directly supervise