Examination of a New Delivery Approach for Oral Cannabidiol in Healthy Subjects: A Randomized, Double-Blinded, Placebo-Controlled Pharmacokinetics Study.

Abstract

Therapeutic effects of cannabidiol (CBD) in specialized populations continue to emerge. Despite supra-physiological dosing being shown to be tolerable in various pathologies, optimization of CBD absorption has obvious benefits for general health and recreational usage. Our objectives were to: (1) to investigate a joint pharmacokinetic-physiological time course of multiple recreational-equivalent (< 100mg) dosages of oral CBD in young healthy adults and (2) evaluate a newly developed technology (TurboCBD™) for the enhanced delivery of CBD. In a double-blinded, placebo-controlled, cross-over design, 12 participants received placebo, generic 45 or 90mg of CBD, or TurboCBD™ delivery technology capsules on five separate occasions. Although there were no differences in the 45mg conditions, circulating CBD levels were higher with the TurboCBD™90mg group at both 90 (+ 86%) and 120 (+ 65%) min compared with the 90mg control (p < 0.05). Total area under the curve tended to be higher with TurboCBD™ 90mg compared with 90mg (10,865 ± 6322ngml-1 vs. 7114 ± 2978ngml-1; p = 0.088). Only the TurboCBD™ 90mg dose was elevated greater than placebo at 30min (p = 0.017) and remained elevated at 4h (p = 0.002). Consistent with higher bioavailability, TurboCBD™90mg at the peak CBD concentration was associated with an increase in cerebral perfusion and slight reduction in blood pressure compared with baseline and the 90mg control. Further studies are needed to establish the mechanisms of action of this technology and to explore the therapeutic potential of acute and chronic dosing on more at-risk populations. Lexaria Bioscience Corp. ClinicalTrials.gov identifier, NCT03295903.