Measuring Environmental Tobacco and Cannabis: Pollutants and Exposures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change in the concentration of urinary cannabinoid metabolites in health nonsmokers exposed to cannabis smoke and emissions
研究概览
简要总结
This is an unblinded pilot study of an environmental exposure to secondhand cannabis smoke in one group of healthy nonsmokers.
详细描述
The goal is to gather accurate information on uptake of smoke toxicants from cannabis exposures in the real world. The investigators will be taking healthy nonsmokers to public places where people are consuming cannabis and measuring their uptake of cannabinoids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
The exposure cannot be masked or blinded. Data analysts and chemists will be blinded.
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult nonsmokers, aged 21-50, who:
- •Are healthy on the basis of medical history
- •Have systolic blood pressure <150
- •Have diastolic blood pressure <100
- •Have BMI between 18.1 and 34.9
- •Able to perform moderate exercise,
- •Are not exposed to tobacco or cannabis SHS in their daily lives. (Nonsmoking status and low SHS exposure are determined by self-report on the screening questionnaire, salivary cotinine < 10 ng/ml and THC < 50 ng/m and exhaled CO2 below 4 ppm)
排除标准
- •Current use of cannabis products, including CBD and edible THC products
- •Regular exposure to secondhand tobacco or cannabis smoke
- •Positive SARS-CoV-2 antibody test
- •Age 18 < or > 50
- •Physician diagnosis of asthma, heart disease, hypertension, thyroid disease, diabetes, renal or liver impairment or glaucoma.
- •Unstable psychiatric condition (such as current major depression, history of schizophrenia or bipolar disorder) or current use of more than two psychiatric medications
- •Systolic blood pressure > 150
- •Diastolic blood pressure > 100
- •Pregnancy or breastfeeding (by urine hCG and/or history)
- •Alcohol or illicit drug dependence within the past 5 years
- •BMI > 35 and < 18
- •Current illicit drug use (by history or urine test)
- •More than 1 pack year smoking history
- •Ever a daily marijuana smoker
- •Smoked anything within the last 2 months
- •Occupational exposure to smoke, dusts OR fumes
- •Concurrent participation in another clinical trial
- •Unable to communicate in English
- •No social security number
研究组 & 干预措施
Exposure to secondhand cannabis smoke in public places
The research staff and participants will travel together to a public location by either ride share vehicles, taxis or public transit. The study will arrange and pay for the transit. Staff and participants will be exposed to ambient air in public places where cannabis products are being consumed by smoking, vaporizing or dabbing. Participants will remain in the company of the laboratory staff throughout the exposure. The exposures will last 0.5-4 hours, depending on the nature and duration of the event. Staff and participants will travel together back to the laboratory for the post-exposure study measures.
干预措施: Secondhand cannabis emissions/smoke exposure (Other)
结局指标
主要结局
Change in the concentration of urinary cannabinoid metabolites in health nonsmokers exposed to cannabis smoke and emissions
时间窗: Baseline (before exposure) and the morning after exposure, up to 22 hours.
The concentration of 11-Nor-9-carboxy-THC will be measured in urine with LC/MS-MS. The LOQ for this assay is 15 pg/ml. Anticipated changes in concentration are from BLOQ to 0.5-20 ng/ml. The duration of the exposures will depend on the event or venue at which exposures occur, ranging from 30 minutes to 4 hours. The investigators will compare the concentration of 11-Nor-9-carboxy-THC in participants' urine before exposure to concentrations in the first void of the morning after the day of exposure.
次要结局
未报告次要终点