Examination of a New Delivery Approach for Oral Cannabidiol in Healthy Subjects: A Randomized, Double-Blinded, Placebo-Controlled Pharmacokinetics Study
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 (< 100 mg) 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 90 mg of CBD, or TurboCBD™ delivery technology capsules on five separate occasions.
Although there were no differences in the 45 mg conditions, circulating CBD levels were higher with the TurboCBD™ 90 mg group at both 90 (+ 86%) and 120 (+ 65%) min compared with the 90 mg control (p < 0.05). Total area under the curve tended to be higher with TurboCBD™ 90 mg compared with 90 mg (10,865 ± 6322 ng ml−1 vs. 7114 ± 2978 ng ml−1; p = 0.088). Only the TurboCBD™ 90 mg dose was elevated greater than placebo at 30 min (p = 0.017) and remained elevated at 4 h (p = 0.002).
Consistent with higher bioavailability, TurboCBD™ 90 mg at the peak CBD concentration was associated with an increase in cerebral perfusion and slight reduction in blood pressure compared with baseline and the 90 mg 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.
KeywordsCannabidiol Cerebrovascular conductance Gas chromatography-mass spectrometry Pharmacokinetics
The authors would like to thank the participants of the study.
The study was sponsored by Lexaria Bioscience Corp., who also funded the Rapid Service Fees. All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis.
All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.
Philip N Ainslie acts as a Scientific Advisor for Lexaria Bioscience Corp. Alexander Patrician, Maja Versic-Bratincevic, Tanja Mijackia, Ivana Banic, Mario Marendic, Davorka Sutlović and Željko Dujić declare they have no conflict of interest.
Compliance with Ethics Guidelines
All procedures were performed in accordance with the Ethics Committee at the University of Split School of Medicine and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. All participants provided written informed consent prior to completion of any data collection.
The datasets generated and/or analyzed during the current study are not yet publicly available, but are available upon request.
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