NCT03295903

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jan 2018

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 28, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

October 23, 2019

Status Verified

October 1, 2019

Enrollment Period

3.7 years

First QC Date

September 20, 2017

Last Update Submit

October 21, 2019

Conditions

Diet Modification

Keywords

Vascular functionCannabidiol supplementation

Outcome Measures

Primary Outcomes (2)

  • Circulating cannabidiol and nitric oxide markers

    Measured by venous blood sampling

    Through study completion, an average of 1 year

  • Vascular function

    Duplex ultrasound system

    Through study completion, an average of 1 year

Secondary Outcomes (12)

  • Height

    Through study completion, an average of 1 year

  • Weight

    Through study completion, an average of 1 year

  • Body mass index

    Through study completion, an average of 1 year

  • Systolic blood pressure

    Through study completion, an average of 1 year

  • Diastolic blood pressure

    Through study completion, an average of 1 year

  • +7 more secondary outcomes

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Sugar pill that will have no effect.

Dietary Supplement: Cannabidiol supplement

Cannabidiol and herbal capsules (1 dose)

ACTIVE COMPARATOR

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

Dietary Supplement: Cannabidiol supplement

Cannabidiol (1 dose)

ACTIVE COMPARATOR

Only cannabidiol supplement.

Dietary Supplement: Cannabidiol supplement

Cannabidiol and herbal capsules (2 dose)

ACTIVE COMPARATOR

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

Dietary Supplement: Cannabidiol supplement

Cannabidiol only (2 dose)

ACTIVE COMPARATOR

Only cannabidiol supplement.

Dietary Supplement: Cannabidiol supplement

Interventions

Cannabidiol supplementDIETARY_SUPPLEMENT

Subjects will be administered in a double-blinded, randomized and cross-over design

Cannabidiol (1 dose)Cannabidiol and herbal capsules (1 dose)Cannabidiol and herbal capsules (2 dose)Cannabidiol only (2 dose)Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia

Kelowna, Ontario, V1V 1V7, Canada

Location

Related Publications (1)

  • 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: 31512143DERIVED

Study Design

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

Study Record Dates

First Submitted

September 20, 2017

First Posted

September 28, 2017

Study Start

January 1, 2018

Primary Completion

September 30, 2021

Study Completion

October 1, 2021

Last Updated

October 23, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Individual values will be reported in figures if applicable.

Locations

CA(1)