Literature DB >> 31512143

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

Alexander Patrician1, Maja Versic-Bratincevic2, Tanja Mijacika3, Ivana Banic3, Mario Marendic4, Davorka Sutlović2,5, Željko Dujić3, Philip N Ainslie6.   

Abstract

INTRODUCTION: 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.
METHODS: 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.
RESULTS: 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).
CONCLUSION: 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. FUNDING: Lexaria Bioscience Corp. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT03295903.

Entities:  

Keywords:  Cannabidiol; Cerebrovascular conductance; Gas chromatography-mass spectrometry; Pharmacokinetics 

Mesh:

Substances:

Year:  2019        PMID: 31512143     DOI: 10.1007/s12325-019-01074-6

Source DB:  PubMed          Journal:  Adv Ther        ISSN: 0741-238X            Impact factor:   3.845


  9 in total

Review 1.  Cannabinoid Formulations and Delivery Systems: Current and Future Options to Treat Pain.

Authors:  Barbara Stella; Francesca Baratta; Carlo Della Pepa; Silvia Arpicco; Daniela Gastaldi; Franco Dosio
Journal:  Drugs       Date:  2021-09-04       Impact factor: 9.546

2.  Statement on safety of cannabidiol as a novel food: data gaps and uncertainties.

Authors:  Dominique Turck; Torsten Bohn; Jacqueline Castenmiller; Stefaan De Henauw; Karen Ildico Hirsch-Ernst; Alexandre Maciuk; Inge Mangelsdorf; Harry J McArdle; Androniki Naska; Carmen Pelaez; Kristina Pentieva; Alfonso Siani; Frank Thies; Sophia Tsabouri; Marco Vinceti; Francesco Cubadda; Thomas Frenzel; Marina Heinonen; Rosangela Marchelli; Monika Neuhäuser-Berthold; Morten Poulsen; Miguel Prieto Maradona; Josef Rudolf Schlatter; Viviana Trezza; Henk van Loveren; Océane Albert; Céline Dumas; Andrea Germini; Wolfgang Gelbmann; Georges Kass; Eirini Kouloura; Estefania Noriega Fernandez; Annamaria Rossi; Helle Katrine Knutsen
Journal:  EFSA J       Date:  2022-06-07

3.  Food effects on the formulation, dosing, and administration of cannabidiol (CBD) in humans: A systematic review of clinical studies.

Authors:  Lucy H Silmore; Andrew R Willmer; Edmund V Capparelli; Gus R Rosania
Journal:  Pharmacotherapy       Date:  2021-03-18       Impact factor: 4.705

4.  Urinary Pharmacokinetic Profile of Cannabidiol (CBD), Δ9-Tetrahydrocannabinol (THC) and Their Metabolites following Oral and Vaporized CBD and Vaporized CBD-Dominant Cannabis Administration.

Authors:  Dennis J Sholler; Tory R Spindle; Edward J Cone; Elia Goffi; David Kuntz; John M Mitchell; Ruth E Winecker; George E Bigelow; Ronald R Flegel; Ryan Vandrey
Journal:  J Anal Toxicol       Date:  2022-05-20       Impact factor: 3.220

Review 5.  Pharmacokinetics of Cannabis and Its Derivatives in Animals and Humans During Pregnancy and Breastfeeding.

Authors:  Anaëlle Monfort; Ema Ferreira; Grégoire Leclair; Gregory Anton Lodygensky
Journal:  Front Pharmacol       Date:  2022-07-12       Impact factor: 5.988

6.  Chronic Effects of Effective Oral Cannabidiol Delivery on 24-h Ambulatory Blood Pressure and Vascular Outcomes in Treated and Untreated Hypertension (HYPER-H21-4): Study Protocol for a Randomized, Placebo-Controlled, and Crossover Study.

Authors:  Marko Kumric; Josko Bozic; Goran Dujic; Josip Vrdoljak; Zeljko Dujic
Journal:  J Pers Med       Date:  2022-06-24

Review 7.  A Review of Hemp as Food and Nutritional Supplement.

Authors:  Pellegrino Cerino; Carlo Buonerba; Giuseppe Cannazza; Jacopo D'Auria; Ermete Ottoni; Andrea Fulgione; Antonio Di Stasio; Biancamaria Pierri; Alfonso Gallo
Journal:  Cannabis Cannabinoid Res       Date:  2021-02-12

Review 8.  Therapeutic Applications of Cannabinoids in Cardiomyopathy and Heart Failure.

Authors:  J A Garza-Cervantes; M Ramos-González; O Lozano; C Jerjes-Sánchez; G García-Rivas
Journal:  Oxid Med Cell Longev       Date:  2020-10-27       Impact factor: 6.543

Review 9.  The Effects of Cannabidiol, a Non-Intoxicating Compound of Cannabis, on the Cardiovascular System in Health and Disease.

Authors:  Aleksandra Kicman; Marek Toczek
Journal:  Int J Mol Sci       Date:  2020-09-14       Impact factor: 5.923

  9 in total

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