Cannabinoid Supplementation on Vascular and Cognitive Function

University of British Columbia

Status and phase: Unknown; Early Phase 1

Conditions: Diet Modification

Treatments: Dietary Supplement: Cannabidiol supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT03295903

H17-01957

Details and patient eligibility

About

Cannabidiol (CBD) is a bioactive cannabinoid compound in marijuana (cannabis sativa), but unlike Δ9 tetrahydrocannabinol (THC), lacks the psychoactivity effect of THC. Available evidence suggests that there are marked therapeutic CBD effects for diverse disease processes including inflammation, cancers, psychosis, and epileptic seizures. The purpose of this study, in both younger and older healthy humans, is to improve our understanding of how CBD might control and regulate blood vessel health as well as cognitive and exercise performance.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• non-smoking
• non-obese
• between the ages of 18-30 & 60-75 years
• have no history of cardiopulmonary, liver, gastrointestinal, kidney or cerebrovascular disease.

Exclusion criteria

• are obese
• are taking prescription drugs or over-the-counter supplements that influence cardiovascular or nitric oxide metabolism
• have a history of smoking
• have history of cardiovascular, respiratory (including asthma) or neurological disease
• have known intolerance to ginseng or ginkgo herbals
• have kidney, gastrointestinal or liver disease
• have epilepsy
• have diabetes
• are pregnant or breast feeding
• do not speak English as first language
• a student in the University of British Columbia (UBC) Okanagan Centre for Heart, Lung and Vascular Health
• medical or recreational use of cannabis
• clinically diagnosed anxiety or depression
• history of opioid use
• unwilling or unable to execute the informed consent documentation

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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24 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Sugar pill that will have no effect.

Treatment:

Dietary Supplement: Cannabidiol supplement

Cannabidiol and herbal capsules (1 dose)

Active Comparator group

Description:

Cannabidiol supplement with added ginseng, ginkgo biloba, and organic hemp oil.

Treatment:

Dietary Supplement: Cannabidiol supplement

Cannabidiol (1 dose)

Active Comparator group

Description:

Only cannabidiol supplement.

Treatment:

Dietary Supplement: Cannabidiol supplement

Cannabidiol and herbal capsules (2 dose)

Active Comparator group

Description:

Cannabidiol supplement with added ginseng, ginkgo biloba, and organic hemp oil.

Treatment:

Dietary Supplement: Cannabidiol supplement

Cannabidiol only (2 dose)

Active Comparator group

Description:

Only cannabidiol supplement.

Treatment:

Dietary Supplement: Cannabidiol supplement