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Cannabis Inhalation: Effects on Cardiovascular Function During Rest and Exercise

J

Jamie Burr

Status and phase

Completed
Early Phase 1

Conditions

Cannabis
Cardiovascular Risk Factor

Treatments

Drug: Cannabis

Study type

Interventional

Funder types

Other

Identifiers

NCT04693884
UOG-HPL-CAN (REB# 18-11-013)

Details and patient eligibility

About

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.

Enrollment

22 patients

Sex

All

Ages

19 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

22 participants in 4 patient groups

High THC, Smoked
Experimental group
Treatment:
Drug: Cannabis
Drug: Cannabis
Drug: Cannabis
Drug: Cannabis
High THC, Vaporized
Experimental group
Treatment:
Drug: Cannabis
Drug: Cannabis
Drug: Cannabis
Drug: Cannabis
High CBD, Smoked
Experimental group
Treatment:
Drug: Cannabis
Drug: Cannabis
Drug: Cannabis
Drug: Cannabis
High CBD, Vaporized
Experimental group
Treatment:
Drug: Cannabis
Drug: Cannabis
Drug: Cannabis
Drug: Cannabis

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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