Status:
COMPLETED
Oral Cannabidiol Effect on Blood Pressure in Hypertensive Patients
Lead Sponsor:
University of Split, School of Medicine
Collaborating Sponsors:
Lexaria Bioscience Corp.
University of British Columbia
Conditions:
Hypertension
Eligibility:
All Genders
40-70 years
Phase:
PHASE1
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 h...
Detailed Description
Research Design A double-blind, placebo-controlled, cross-over pilot study in which 60 volunteers (aged 40-70 years) will visit to laboratory on six occasions following an overnight fast. All particip...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
April 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2022
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05346562
Start Date
April 8 2022
End Date
October 5 2022
Last Update
May 16 2023
Active Locations (1)
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1
University of Split School of medicine
Split, Croatia, 21000