Measuring Environmental Tobacco and Cannabis: Pollutants and Exposures

NCT ID: NCT06030674

Last Updated: 2023-09-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2026-06-30

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Secondhand cannabis emissions/smoke exposure

Intervention Type: OTHER

This is an environmental exposure performed in public places where people are consuming cannabis.

Interventions

Secondhand cannabis emissions/smoke exposure

This is an environmental exposure performed in public places where people are consuming cannabis.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suzaynn F Schick

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Zuckerberg San Francisco General Hospital

San Francisco, California, United States

Countries

United States

Central Contacts

Suzaynn F Schick, Phd

Role: CONTACT

suzaynn.schick@ucsf.edu

4155143535

Abel Huang, BS

Role: CONTACT

abel.huang@ucsf.edu

415-514-9011

Other Identifiers

T32IR4867

Identifier Type: -

Identifier Source: org_study_id