Measuring Environmental Tobacco and Cannabis: Pollutants and Exposures

Study Overview
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Brief Summary
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This is an unblinded pilot study of an environmental exposure to secondhand cannabis smoke in one group of healthy nonsmokers.

Detailed Description
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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.

Official Title
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Measuring Environmental Tobacco and Cannabis: Pollutants and Exposures

Conditions
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Healthy

Intervention / Treatment
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* Other: Secondhand cannabis emissions/smoke exposure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: This is an unblinded pilot study of an environmental exposure in one group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exposure to secondhand cannabis smoke in public places<br>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. | Other: Secondhand cannabis emissions/smoke exposure<br>* This is an environmental exposure performed in public places where people are consuming cannabis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the concentration of urinary cannabinoid metabolites in health nonsmokers exposed to cannabis smoke and emissions | 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. | Baseline (before exposure) and the morning after exposure, up to 22 hours. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nonsmokers, Secondhand cannabis smoke, Environmental cannabis, Exposure