Cannabis Inhalation: Effects on Cardiovascular Function During Rest and Exercise

NCT ID: NCT04693884

Last Updated: 2025-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2025-04-16

Brief Summary

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This two-phase project seeks to examine the cardiovascular response to consumption of cannabis variants of different cannabinoid composition through different methods (smoking vs. vaporizing), at rest and during aerobic exercise. Multiple measures that have been shown to predict risk factors for chronic-disease and negative health outcomes will be assessed following cannabis consumption at rest or in combination with exercise. These techniques will examine arterial stiffness, vascular function, and cardiac function. In phase I and II, subjects will visit the lab on 6 different occasions; with 1 visit acting as an introductory visit, 1 as an exercise control visit, 2 as resting cannabis visits, and 2 as cannabis + exercise visits. Cannabis used in phase I of this study will consist of approximately 10% THC. On all visits, pulse wave velocity, flow mediated dilation, and echocardiography measures will be performed following cannabis consumption by smoking or vaporizing, and cannabis consumption by smoking or vaporizing followed by 20 minutes of exercise on a cycle ergometer. Phase II of the study will implore a similar design. In favor of altering method of consumption, in all visits cannabis will be consumed by vaporization and will be either a high cannabidiol (CBD: (\~10%)) and low delta-9-tetrahydrocannabinol (THC: (\<1%)), or a high THC (\~10%) and low CBD (\<1%) variant.

Detailed Description

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Conditions

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Cannabis Cardiovascular Risk Factor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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High THC, Smoked

Group Type EXPERIMENTAL

Cannabis

Intervention Type DRUG

Cannabis of (\~10% THC concentration \<1% CBD concentration) will be smoked.

High THC, Vaporized

Group Type EXPERIMENTAL

Cannabis

Intervention Type DRUG

Cannabis of (\~10% THC concentration \<1% CBD concentration) will be vaporized.

High CBD, Smoked

Group Type EXPERIMENTAL

Cannabis

Intervention Type DRUG

Cannabis of (\~10% CBD concentration \<1% THC concentration) will be smoked.

High CBD, Vaporized

Group Type EXPERIMENTAL

Cannabis

Intervention Type DRUG

Cannabis of (\~10% CBD concentration \<1% THC concentration) will be vaporized.

Interventions

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Cannabis

Cannabis of (\~10% THC concentration \<1% CBD concentration) will be smoked.

Intervention Type DRUG

Cannabis

Cannabis of (\~10% THC concentration \<1% CBD concentration) will be vaporized.

Intervention Type DRUG

Cannabis

Cannabis of (\~10% CBD concentration \<1% THC concentration) will be smoked.

Intervention Type DRUG

Cannabis

Cannabis of (\~10% CBD concentration \<1% THC concentration) will be vaporized.

Intervention Type DRUG

Other Intervention Names

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High THC, Smoked High THC, Vaporized High CBD, Smoked High CBD, Vaporized

Eligibility Criteria

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Inclusion Criteria

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 19-45yr
4. In good general health as evidenced by medical history and free of chronic disease
5. Must be experienced with cannabis use. This requires recreational cannabis use of a minimum of once per week in the past 30 days as confirmed by urine test
6. Experience consuming cannabis recreationally by vaping dried cannabis

Exclusion Criteria

1. Deemed unfit to exercise by the PARQ+.
2. Current or past diagnoses of substance abuse disorder
3. Failure of recreational substance urine screening test
4. Current, past, or strong family history of psychosis, or has previously experienced a cannabis-related psychotic episode
5. Current or past diagnoses of cannabis use disorder
6. Current or past diagnoses of any mood or anxiety disorder
7. Identified ECG abnormalities
8. Systolic blood pressure exceeding 160mmHg
9. Diastolic blood pressure exceeding 90mmHg
10. Resting heart rate exceeding 100bpm, or lower than 40bpm
11. Diagnosed with respiratory disease
12. Diagnosed with cardiovascular disease
13. Diagnosed with liver disease
14. Diagnosed with kidney disease
15. Is Pregnant or planning to be pregnant
16. Currently taking prescription medication (excluding contraceptive medication)
17. Is a cigarette smoker
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jamie Burr

OTHER

Sponsor Role lead

Responsible Party

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Jamie Burr

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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University of Guelph

Guelph, Ontario, Canada

Site Status

Countries

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Canada

References

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Cheung CP, Coates AM, Baker RE, Burr JF. Acute Effects of Cannabis Inhalation on Arterial Stiffness, Vascular Endothelial Function, and Cardiac Function. J Am Heart Assoc. 2024 Dec 3;13(23):e037731. doi: 10.1161/JAHA.124.037731. Epub 2024 Nov 22.

Reference Type DERIVED
PMID: 39575727 (View on PubMed)

Cheung CP, Nardone M, Lee JB, Baker RE, Millar PJ, Burr JF. Cannabis Inhalation Acutely Reduces Muscle Sympathetic Nerve Activity in Humans. Circulation. 2022 Dec 20;146(25):1972-1974. doi: 10.1161/CIRCULATIONAHA.122.062564. Epub 2022 Oct 31. No abstract available.

Reference Type DERIVED
PMID: 36314198 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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UOG-HPL-CAN (REB# 18-11-013)

Identifier Type: -

Identifier Source: org_study_id

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