Measuring Environmental Tobacco and Cannabis: Pollutants and Exposures

Not Applicable

Not yet recruiting

• Conditions: Healthy

• Registration Number: NCT06030674
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study First Submitted: 2023-08-25
• Status Verified: 2023-09
• Study Start: 2023-09-01
• Study First Submitted QC: 2023-09-01
• Last Update Submitted: 2023-09-01
• Study First Posted: 2023-09-11
• Last Update Posted: 2023-09-11
• Primary Completion: 2025-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in the concentration of urinary cannabinoid metabolites in health nonsmokers exposed to cannabis smoke and emissions	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.

Trial Locations

Locations (1)

Zuckerberg San Francisco General Hospital; 🇺🇸 San Francisco, California, United States