Measuring Environmental Tobacco and Cannabis: Pollutants and Exposures

NCT06030674 | Not Yet Recruiting

• 1 other identifier: T32IR4867
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Nonsmokers; Secondhand cannabis smoke; Environmental cannabis; Exposure

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Exposure to secondhand cannabis smoke in public places

EXPERIMENTAL

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

Interventions

Secondhand cannabis emissions/smoke exposure OTHER

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

Exposure to secondhand cannabis smoke in public places

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

Location

MeSH Terms

Interventions

Smoke

Intervention Hierarchy (Ancestors)

Particulate Matter; Complex Mixtures

Study Officials

• Suzaynn F Schick

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suzaynn F Schick, Phd

CONTACT

4155143535; suzaynn.schick@ucsf.edu

Abel Huang, BS

CONTACT

415-514-9011; abel.huang@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The exposure cannot be masked or blinded. Data analysts and chemists will be blinded.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an unblinded pilot study of an environmental exposure in one group.

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: September 11, 2023
• Study Start: September 1, 2023
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)