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Oral Cannabidiol Effect on Blood Pressure in Hypertensive Patients (HYPER-H21-4)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05346562
Recruitment Status : Active, not recruiting
First Posted : April 26, 2022
Last Update Posted : April 26, 2022
Sponsor:
Collaborators:
Lexaria Bioscience Corp
University of British Columbia
University of Colorado, Denver
Information provided by (Responsible Party):
Zeljko Dujic, University of Split, School of Medicine

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.

Condition or disease Intervention/treatment Phase
Hypertension Dietary Supplement: Cannabidiol Dietary Supplement: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chronic Effects of Effective Oral Cannabidiol Delivery on 24-hour Ambulatory Blood Pressure and Vascular Outcomes in Treated and Untreated Hypertension: A Randomized, Placebo-controlled and Crossover Study
Actual Study Start Date : April 8, 2022
Estimated Primary Completion Date : October 5, 2022
Estimated Study Completion Date : April 5, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Cannabidiol

Arm Intervention/treatment
Experimental: Cannabidiol, then Placebo
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
Cannabidiol tablets

Dietary Supplement: Placebo
Cannabidiol-matched placebo tablets

Experimental: Placebo, then Cannabidiol
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
Cannabidiol tablets

Dietary Supplement: Placebo
Cannabidiol-matched placebo tablets




Primary Outcome Measures :
  1. 24-hour ambulatory blood pressure [ Time Frame: Through study completion, an average of 1 year ]
    Measured by ambulatory blood pressure monitoring system


Secondary Outcome Measures :
  1. The burning of calories through physical activity [ Time Frame: Through study completion, an average of 1 year ]
    Measured in kcal by wrist-based health & fitness tracker

  2. Number of awakenings [ Time Frame: Through study completion, an average of 1 year ]
    Measured by wrist-based health & fitness tracker

  3. Total sleep time [ Time Frame: Through study completion, an average of 1 year ]
    Measured by wrist-based health & fitness tracker

  4. Total wake time [ Time Frame: Through study completion, an average of 1 year ]
    Measured by wrist-based health & fitness tracker

  5. Circulating cannabidiol [ Time Frame: Through study completion, an average of 1 year ]
    Measured by venous blood sampling

  6. Nitric oxide markers [ Time Frame: Through study completion, an average of 1 year ]
    Measured by venous blood sampling

  7. C-reactive protein concentration in serum [ Time Frame: Through study completion, an average of 1 year ]
    Measured by venous blood sampling

  8. Arterial stiffness [ Time Frame: Through study completion, an average of 1 year ]
    Measured by pulse wave analysis

  9. Volume of hippocampus [ Time Frame: Through study completion, an average of 1 year ]
    Measured by MRI, T1-MPRAGE sequence

  10. Blood flow through a. carotis interna [ Time Frame: Through study completion, an average of 1 year ]
    Measured by MRI, 4D flow

  11. Blood cholesterol concentration in serum [ Time Frame: Through study completion, an average of 1 year ]
    Measured by venous blood sampling

  12. Catestatin concentration in serum [ Time Frame: Through study completion, an average of 1 year ]
    Measured by venous blood sampling

  13. Liver enzymes in serum [ Time Frame: Through study completion, an average of 1 year ]
    Measured by venous blood sampling

  14. Heart rate [ Time Frame: Through study completion, an average of 1 year ]
    Measured by 3-lead electrocardiogram

  15. Salt intake [ Time Frame: Through study completion, an average of 1 year ]
    Measured by Big life sodium calculator, range from 0 to 100 (higher score indicates higher salt intake)

  16. Sleepiness [ Time Frame: Through study completion, an average of 1 year ]
    Measured by Epworth sleepiness scale; range from 0 to 24 (higher score indicates higher sleepiness)

  17. Geriatric depression [ Time Frame: Through study completion, an average of 1 year ]
    Measured by Geriatric depression scale-short form; range from 0 to 15 (higher score indicates higher propensity for depression in geriatric population)

  18. Physical activity [ Time Frame: Through study completion, an average of 1 year ]
    Measured by Global Physical Activity Questionnaire; Total weekly MET-min is calculated in a following manner: (Minutes engaged in moderate-intensity activity each week X 4 MET) + (Minutes engaged in vigorous-intensity activity each week X 8 MET)

  19. Memory [ Time Frame: Through study completion, an average of 1 year ]
    Measured by Memory Complaint Questionnaire; range from 6 to 35 (higher scores indicate greater decline in memory)

  20. Sleep quality [ Time Frame: Through study completion, an average of 1 year ]
    Measured by Pittsburgh sleep quality index; range from 0 to 21 (higher score indicating worse sleep quality)

  21. Perceived stress [ Time Frame: Through study completion, an average of 1 year ]
    Measured by Perceived stress scale; range from 0 to 40 (higher score indicates higher perceived stress)

  22. General health [ Time Frame: Through study completion, an average of 1 year ]
    Measured by SF-36; range from 0 to 100 (higher scores indicate better health status)

  23. Anxiety [ Time Frame: Through study completion, an average of 1 year ]
    Measured by State-Trait Anxiety Inventory; range from 20 to 80 (higher scores indicates higher level of anxiety)

  24. Obstructive sleep apnea risk [ Time Frame: Through study completion, an average of 1 year ]
    Measured by STOP-BANG; range from 0 to 8 (higher scores indicate higher risk for OSA)

  25. Depression [ Time Frame: Through study completion, an average of 1 year ]
    Measured by Beck's Depression Inventory; range from 0 to 63 (higher score indicates higher level of depression)



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 < 30.0 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.

Exclusion Criteria:

  • 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
  • Liver disease, including, taking valproate, confirmed on baseline blood biochemistry - exclusion of subjects that have > 1.5 upper limit of normal (ULN) for ALT or AST, TBL >ULN at baseline determined by local reference population values in Croatia:

    • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05346562


Locations
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Croatia
University of Split School of medicine
Split, Croatia, 21000
Sponsors and Collaborators
University of Split, School of Medicine
Lexaria Bioscience Corp
University of British Columbia
University of Colorado, Denver
Investigators
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Principal Investigator: Zeljko Dujic, MD, PhD University of Split, School of Medicine
Publications:
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Responsible Party: Zeljko Dujic, Professor, University of Split, School of Medicine
ClinicalTrials.gov Identifier: NCT05346562    
Other Study ID Numbers: 2181-198-01-01-22-0002
First Posted: April 26, 2022    Key Record Dates
Last Update Posted: April 26, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Zeljko Dujic, University of Split, School of Medicine:
hypertension
cannabidiol
arterial stiffness
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Cannabidiol
Anticonvulsants