Oral Cannabidiol Effect on Blood Pressure in Hypertensive Patients

NCT05346562 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 2181-198-01-01-22-0002
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this randomized, placebo-controlled and crossover study is to extend the findings from the acute studies into more chronic administration of CBD in individuals with mild or moderate hypertension who are either untreated or receiving standard care therapy. The hypothesis is that the hypotensive effects of CBD will be apparent in both untreated and treated hypertension and reflected in improved vascular biomarkers and psychological well-being.

Conditions

Hypertension

Keywords

hypertension; cannabidiol; arterial stiffness

Outcome Measures

Primary Outcomes (1)

• 24-hour ambulatory blood pressure

  Measured by ambulatory blood pressure monitoring system

  Through study completion, an average of 1 year

Secondary Outcomes (25)

• The burning of calories through physical activity

  Through study completion, an average of 1 year

• Number of awakenings

  Through study completion, an average of 1 year

• Total sleep time

  Through study completion, an average of 1 year

• Total wake time

  Through study completion, an average of 1 year

• Circulating cannabidiol

  Through study completion, an average of 1 year

Study Arms (2)

Cannabidiol, then Placebo

EXPERIMENTAL

Participant receive cannabidiol: 225 to 300 mg split over three times daily for the initial 2.5 weeks and 375 to 450 mg split over three times for the following 2.5 weeks. After two week washout, participant receives Placebo for five weeks (matching Cannabidiol tablets)

Dietary Supplement: Cannabidiol; Dietary Supplement: Placebo

Placebo, then Cannabidiol

EXPERIMENTAL

Participant receive placebo tablets (matching Cannabidiol pills) for five weeks. After two week washout, Participant receive cannabidiol: 225 to 300 mg split over three times daily for the initial 2.5 weeks and 375 to 450 mg split over three times for the following 2.5 weeks.

Dietary Supplement: Cannabidiol; Dietary Supplement: Placebo

Interventions

Cannabidiol DIETARY_SUPPLEMENT

Cannabidiol tablets

Cannabidiol, then Placebo; Placebo, then Cannabidiol

Placebo DIETARY_SUPPLEMENT

Cannabidiol-matched placebo tablets

Cannabidiol, then Placebo; Placebo, then Cannabidiol

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented or measured elevated blood pressure (120/80 to 139/80 mmHg), mild (stage 1) hypertension (140/90 to 159/99 mmHg) or moderate (stage 2) hypertension (160/100 to 179/109 mmHg)
• Normal or overweight (body mass index 18.5 to 35.0 kg/m2)
• The female subjects are considered post-menopausal, and therefore not of reproductive potential, if they have not menstruated for at least 24 consecutive months in the absence of medications known to induce amenorrhea.
• Heterosexually active female subjects of reproductive potential must be on contraception management using at least one of the following methods while taking study drug and for 30 days following the last dose of study drug:
• Barrier method of contraception \[condoms (male or female), diaphragm, or cervical cap\] with spermicide
• IUD
• Hormone-based oral, injectable, or implantable contraceptive
• Bilateral tubal ligation/cauterization
• Surgically sterile (hysterectomy or bilateral oophorectomy) or vasectomized male partner Undergo \<150 minutes of moderate-to-vigorous activity per week Up to 40 subjects will be included who are not using anti-hypertensive therapy Up to 30 subjects will be included who are being treated with either (1) ACE inhibitors with or without diuretics or (2) ACE inhibitors with Calcium Channel blocker with or without diuretics.

You may not qualify if:

• Current smoker or using vapor-based products; or a medical or recreational cannabis user.
• Have kidney, liver disease (see below) or gastrointestinal disease (e.g., irritable bowel syndrome, celiac disease, Crohn's disease) or has had a cholecystectomy.
• Suffering from chronic diarrhea. (defined as \>3 times loose / watery bowel movements per day lasting for more than 7 days; and occurring at least 4 times per year)
• Current diagnosis or history of any seizure disorder
• have diabetes
• cardiac instability / disease.
• are pregnant or breast feeding, or plan to become pregnant
• history of opioid use
• Dual blood pressure therapy other than ACE inhibitors with diuretic use and ACE inhibitors with Calcium Channel blocker with or without diuretics (e.g., ACE inhibitors with beta blockers)
• unwilling or unable to execute the informed consent documentation
• ULN for ALT 48 IU/L
• ULN for AST 38 IU/L
• ULN for ALP 142 IU/L
• ULN for total bilirubin (TBL) 20 umol/L
• ULN for GGT IU/L 55

Sponsors & Collaborators

• University of Split, School of Medicine: lead
• Lexaria Bioscience Corp.: collaborator
• University of British Columbia: collaborator
• University of Colorado, Denver: collaborator

Study Sites (1)

University of Split School of medicine

Split, 21000, Croatia

Location

Related Publications (6)

• Bergamaschi MM, Queiroz RH, Chagas MH, de Oliveira DC, De Martinis BS, Kapczinski F, Quevedo J, Roesler R, Schroder N, Nardi AE, Martin-Santos R, Hallak JE, Zuardi AW, Crippa JA. Cannabidiol reduces the anxiety induced by simulated public speaking in treatment-naive social phobia patients. Neuropsychopharmacology. 2011 May;36(6):1219-26. doi: 10.1038/npp.2011.6. Epub 2011 Feb 9.

  PMID: 21307846 BACKGROUND

• Granjeiro EM, Gomes FV, Guimaraes FS, Correa FM, Resstel LB. Effects of intracisternal administration of cannabidiol on the cardiovascular and behavioral responses to acute restraint stress. Pharmacol Biochem Behav. 2011 Oct;99(4):743-8. doi: 10.1016/j.pbb.2011.06.027. Epub 2011 Jul 12.

  PMID: 21771609 BACKGROUND

• Jadoon KA, Tan GD, O'Sullivan SE. A single dose of cannabidiol reduces blood pressure in healthy volunteers in a randomized crossover study. JCI Insight. 2017 Jun 15;2(12):e93760. doi: 10.1172/jci.insight.93760. eCollection 2017 Jun 15.

  PMID: 28614793 BACKGROUND

• Patrician A, Versic-Bratincevic M, Mijacika T, Banic I, Marendic M, Sutlovic D, Dujic Z, Ainslie PN. Examination of a New Delivery Approach for Oral Cannabidiol in Healthy Subjects: A Randomized, Double-Blinded, Placebo-Controlled Pharmacokinetics Study. Adv Ther. 2019 Nov;36(11):3196-3210. doi: 10.1007/s12325-019-01074-6. Epub 2019 Sep 12.

  PMID: 31512143 BACKGROUND

• Sultan SR, Millar SA, England TJ, O'Sullivan SE. A Systematic Review and Meta-Analysis of the Haemodynamic Effects of Cannabidiol. Front Pharmacol. 2017 Feb 24;8:81. doi: 10.3389/fphar.2017.00081. eCollection 2017.

  PMID: 28286481 BACKGROUND

• Dujic G, Kumric M, Vrdoljak J, Dujic Z, Bozic J. 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. Cannabis Cannabinoid Res. 2024 Aug;9(4):979-989. doi: 10.1089/can.2022.0320. Epub 2023 Apr 21.

  PMID: 37093160 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Zeljko Dujic, MD, PhD

  University of Split, School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 26, 2022
• Study Start: April 8, 2022
• Primary Completion: October 5, 2022
• Study Completion: October 5, 2022
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)