Measuring Environmental Tobacco and Cannabis: Pollutants and Exposures

Healthy Clinical Trial

— CAN03  

Official title:

Measuring Environmental Tobacco and Cannabis: Pollutants and Exposures

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06030674
• Other study ID #: T32IR4867
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: September 2023
• Source: University of California, San Francisco
• Contact: Suzaynn F Schick, Phd
• Phone: 4155143535
• Email: suzaynn.schick[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Marijuana Abuse

Intervention

Other:
• Secondhand cannabis emissions/smoke exposure
This is an environmental exposure performed in public places where people are consuming cannabis.

Locations

Country	Name	City	State
United States	Zuckerberg San Francisco General Hospital	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.