Clinical trial NCT06030674: Measuring Environmental Tobacco and Cannabis: Pollutants and Exposures
Official title: Measuring Environmental Tobacco and Cannabis: Pollutants and Exposures
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Nonsmokers
Secondhand cannabis smoke
Environmental cannabis
Exposure
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is an unblinded pilot study of an environmental exposure in one group.
Primary purpose: BASIC_SCIENCE

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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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

Primary outcomes:
measure: Change in the concentration of urinary cannabinoid metabolites in health nonsmokers exposed to cannabis smoke and emissions
timeFrame: Baseline (before exposure) and the morning after exposure, up to 22 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Zuckerberg San Francisco General Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Suzaynn F Schick
role: PRINCIPAL_INVESTIGATOR
References: