The Influence of Cannabis Inhalation During Exercise on Cardiovascular Health and Function: Exploring the Optimal Balance of Cannabinoids and Mode of Administration to Decrease Risk and Maximize Benefits
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change in Brachial Artery Vascular Function From Baseline Following Cannabis Consumption
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged 19-45yr
- •In good general health as evidenced by medical history and free of chronic disease
- •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
- •Experience consuming cannabis recreationally by vaping dried cannabis
排除标准
- •Deemed unfit to exercise by the PARQ+.
- •Current or past diagnoses of substance abuse disorder
- •Failure of recreational substance urine screening test
- •Current, past, or strong family history of psychosis, or has previously experienced a cannabis-related psychotic episode
- •Current or past diagnoses of cannabis use disorder
- •Current or past diagnoses of any mood or anxiety disorder
- •Identified ECG abnormalities
- •Systolic blood pressure exceeding 160mmHg
- •Diastolic blood pressure exceeding 90mmHg
- •Resting heart rate exceeding 100bpm, or lower than 40bpm
- •Diagnosed with respiratory disease
- •Diagnosed with cardiovascular disease
- •Diagnosed with liver disease
- •Diagnosed with kidney disease
- •Is Pregnant or planning to be pregnant
- •Currently taking prescription medication (excluding contraceptive medication)
- •Is a cigarette smoker
研究组 & 干预措施
High THC, Smoked
干预措施: Cannabis (Drug)
High THC, Vaporized
干预措施: Cannabis (Drug)
High CBD, Smoked
干预措施: Cannabis (Drug)
High CBD, Vaporized
干预措施: Cannabis (Drug)
结局指标
主要结局
Change in Brachial Artery Vascular Function From Baseline Following Cannabis Consumption
时间窗: Baseline, Post-Intervention (<2 Hours)
Assessed via brachial artery flow mediated dilation (FMD)
Change in Cardiac Function From Baseline Following Cannabis Consumption
时间窗: Baseline, Post-Intervention (<2 Hours)
Measured by echocardiography
Change in Aortic Stiffness From Baseline Following Cannabis Consumption
时间窗: Baseline, Post-Intervention (<2 Hours)
Assessed via carotid-femoral pulse wave velocity (PWV)
Change in Sympathetic Nervous System Activity From Baseline Following Cannabis Consumption
时间窗: Baseline, Post-Intervention (<2 Hours)
Assessed via microneurographic recordings of the peroneal nerve
次要结局
- Systolic Blood Pressure(Baseline, Post-Intervention (<2 Hours))
- Exercise Capacity(Baseline, Post-Intervention (<2 Hours))
- Perceived Exertion(Baseline, Post-Intervention (<2 Hours))
- Diastolic Blood Pressure(Baseline, Post-Intervention (<2 Hours))
- Oxygen Consumption(Baseline, Post-Intervention (<2 Hours))
- Heart Rate(Baseline, Post-Intervention (<2 Hours))
研究者
Jamie Burr
Associate Professor
University of Guelph