PII-120 - AN INTERIM PHARMACOKINETIC (PK) ANALYSIS OF CANNABINOIDS IN SERUM OF VOLUNTEERS RECEIVING COSMETIC HEMP EXTRACT VIA THE ORAL OR TOPICAL ROUTES.

R. Hudson¹, C. Sayre^2,1, J. Rower¹, V. Yellepeddi¹, E. Enioutina¹; ¹University of Utah, Salt Lake City, UT, USA, ²Roseman University of Health Science, South Jordan, UT, USA.

Background: Hemp formulations are used in cosmetics and as dietary supplements. An important consideration for hemp products is the Δ9-tetrahydrocannabinol (THC) content. Although hemp formulations are reportedly THC free, some consumers report positive urine THC tests. The objective of this study was to investigate whether cannabinoids, including THC and its metabolites, were detectable in plasma after a single dose of oral or topical cosmetic hemp extract (HE).

Methods: In this randomized, open-label, single-dose, crossover study, volunteers (n=20) received 200 mg of HE orally or topically with a 15-day washout period. THC content in the HE product was below allowed limits ( < 0.04%). Plasma cannabinoids and their metabolites were quantified with LC-MS/MS. Urine was tested 24 hours after each dose for THC-COOH using THC test strips. The interim PK analysis (n=8) was conducted using non-compartmental analysis.

Results: Cannabidiol (CBD) and 7OH-CBD were detected in the plasma of volunteers receiving HE orally (CBD Cmax 20.1 ng/mL, and AUC0-∞ 231.34 h/ng/mL). Only CBD was detected in the plasma of volunteers receiving topical HE. Cmax and AUC of CBD were 7-10-fold lower after topical administration. THC and THC metabolites were undetectable in plasma samples. Although participants self-reported no prior cannabis use, 50% of volunteers showed positive results for THC-COOH when tested using urine THC test strips.

Conclusion: THC or its metabolites were not detected in plasma samples, despite positive urine tests. A variety of potential explanations exist, including cross-reactivity of COOH-CBD with COOH-THC in the strip, greater persistence/accumulation of THC or its metabolites in urine vs. plasma, and/or inaccurate self-report of the participant’s prior cannabis use. Work to evaluate these hypotheses is ongoing.