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Published Online: 21 April 2023

Chronic Effects of Oral Cannabidiol Delivery on 24-h Ambulatory Blood Pressure in Patients with Hypertension (HYPER-H21-4): A Randomized, Placebo-Controlled, and Crossover Study

Publication: Cannabis and Cannabinoid Research

Abstract

Background: Recent data indicate that cannabidiol (CBD), a nonintoxicating constituent of cannabis, is involved in several aspects of cardiovascular regulation, including blood pressure (BP). However, the impact of chronic CBD administration on 24-h BP and vascular health has not been previously examined in patients with hypertension. The primary aim of this randomized, triple-blind, placebo-controlled, and crossover study was to examine the influence of chronic CBD on 24-h ambulatory BP and arterial stiffness in hypertensive patients.
Methods: Seventy patients with mild or moderate primary hypertension, who were untreated or receiving standard of care therapy, were randomly assigned to receive either 5 weeks of oral CBD or placebo-matched controls. Following a >2-week washout period, patients were crossed over to alternate therapy. The primary outcome of the study was dynamic in 24-h ambulatory BP and was assessed using two-way repeated measure analysis of variance.
Results: Administration of CBD reduced average 24 h mean, systolic, and diastolic BP after 2.5 weeks (−3.22±0.90 mmHg [95% confidence interval −1.01 to −5.44 mmHg], −4.76±1.24 mmHg [−1.72 to −7.80 mmHg], and −2.25±0.80 mmHg [−0.30 to −6.01 mmHg], respectively (all p<0.05); however, these values largely remained stable following the uptitration of CBD dosing. There were no changes in liver enzymes or serious adverse events (AEs). There was no significant difference in pulse wave velocity (group×factor interaction: F=1.50, p=0.226) at different time points, regardless of the intervention arm.
Conclusions: In conclusion, chronic administration of CBD reduces ambulatory BP in those with untreated and treated hypertension. In addition, lack of serious AEs implies safety and tolerability of the above-noted CBD formulation. ClinicalTrials.gov ID: NCT05346562, Registered April 6th 2022.

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Cite this article as: Dujic G, Kumric M, Vrdoljak J, Dujic Z, Bozic J (2023) Chronic effects of oral cannabidiol delivery on 24h ambulatory blood pressure in patients with hypertension (HYPER-H21-4): a randomized, placebo-controlled, and crossover study, Cannabis and Cannabinoid Research X:X, 1–11, DOI: 10.1089/can.2022.0320.

Information & Authors

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Published In

cover image Cannabis and Cannabinoid Research
Cannabis and Cannabinoid Research
PubMed: 37093160

History

Published online: 21 April 2023

Topics

Authors

Affiliations

Goran Dujic
Clinical Department of Diagnostic and Interventional Radiology, University Hospital of Split, Split, Croatia.
Department of Pathophysiology, University of Split School of Medicine, Split, Croatia.
Josip Vrdoljak
Department of Pathophysiology, University of Split School of Medicine, Split, Croatia.
Zeljko Dujic* [email protected]
Department of Integrative Physiology, University of Split School of Medicine, Split, Croatia.
Department of Pathophysiology, University of Split School of Medicine, Split, Croatia.

Notes

*
Address correspondence to: Zeljko Dujic, MD, PhD, Department of Integrative Physiology, University of Split School of Medicine, Soltanska 2, Split 21000, Croatia. [email protected]
*
Address correspondence to: Josko Bozic, MD, PhD, Department of Pathophysiology, University of Split School of Medicine, Soltanska 2, Split 21000, Croatia. [email protected]

Authors' Contributions

G.D.: Participated in conceptualization, methodology, investigation, formal analysis, and original draft preparation. M.K. and J.V.: Participated in visualization, investigation, formal analysis, and original draft preparation. Z.D. and J.B.: Participated in conceptualization, funding acquisition, resources, project administration, and reviewing and editing of the article.

Author Disclosure Statement

Not applicable.

Funding Information

The study was sponsored by Lexaria Bioscience Corp (Grant number: 2181-198-01-01-22-0002). 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.

Ethics Considerations

The Ethics Committee of the University of Split School of Medicine approved the study on December 15, 2021 (Class: 003-08/21-03/0003; Reg. No.: 2181-198-03-04-21-0091), and all patients signed a written informed consent after they were informed about the procedures, safety, and purpose of this research.

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