Effects Of Cannabis Products On Blood Pressure Control
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- Mayo Clinic
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Blood Pressure
研究概览
简要总结
To investigate the effects of Dronabinol use on blood pressure and neurovascular physiology
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recreational occasional Cannabis use (Consuming THC less than 2 times a week)
- •21 - 40 years of age
- •Biological male or female
排除标准
- •BMI > 35 kg/m2
- •Diagnosed psychiatric disorders
- •Hypotension
- •History of seizures
- •History of substance abuse or recreational drug use or positive urine drug screen
- •History of uncontrolled disease including:
- •Cardiovascular
- •Pulmonary
- •Gastrointestinal
- •Pancreatic
- •Hematological
- •Endocrine (including Type I Diabetes)
- •Neurological
- •Urological
- •Sleep disorders
- •Pregnant or breastfeeding
- •Use of certain antimicrobial, chemotherapeutic, anticoagulant, hypoglycemic, anti-inflammatory, psychotropic, and antihistamine drugs
- •Prescribed CYP2C9 and/or CYP3A4 inhibitors
- •History of shift work or rotating shifts within 1 month
研究组 & 干预措施
Dronabinol Group
Patients taking Dronabinol first and Placebo second
干预措施: Dronabinol (Drug)
Placebo Group
Patients taking Placebo first and Dronabinol second
干预措施: Placebo (Drug)
Placebo Group
Patients taking Placebo first and Dronabinol second
干预措施: Dronabinol (Drug)
Dronabinol Group
Patients taking Dronabinol first and Placebo second
干预措施: Placebo (Drug)
结局指标
主要结局
Blood Pressure
时间窗: Baseline, 30 days
Blood pressure is the force exerted by circulating blood on the walls of the arteries as it is pumped through the body. Blood pressure will be measured as a ratio of systolic/diastolic (mmHg).
Heart Rate
时间窗: Baseline, 30 days
Heart Rate is the number of contractions (beats) that the heart makes per minute. This will be measured in bpm (beats per minute)
次要结局
- Flow Mediated Dilation(Baseline, 30 days)
- Aortic Wave Reflection(Baseline, 30 days)
- Baroreflex Sensitivity(Baseline, 30 days)
- Sympathetic control(Baseline, 30 days)
研究者
Virend Somers, MD, PhD
Principal Investigator
Mayo Clinic