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Measuring Environmental Tobacco and Cannabis: Pollutants and Exposures (CAN03)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06030674
Recruitment Status : Not yet recruiting
First Posted : September 11, 2023
Last Update Posted : September 11, 2023
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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

Condition or disease Intervention/treatment Phase
Healthy Other: Secondhand cannabis emissions/smoke exposure Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is an unblinded pilot study of an environmental exposure in one group.
Masking: None (Open Label)
Masking Description: The exposure cannot be masked or blinded. Data analysts and chemists will be blinded.
Primary Purpose: Basic Science
Official Title: Measuring Environmental Tobacco and Cannabis: Pollutants and Exposures
Estimated Study Start Date : September 1, 2023
Estimated Primary Completion Date : June 30, 2025
Estimated Study Completion Date : June 30, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Other: Secondhand cannabis emissions/smoke exposure
This is an environmental exposure performed in public places where people are consuming cannabis.


Outcome Measures
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Primary Outcome Measures :
  1. Change in the concentration of urinary cannabinoid metabolites in health nonsmokers exposed to cannabis smoke and emissions [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06030674


Contacts
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Contact: Suzaynn F Schick, Phd 4155143535 suzaynn.schick@ucsf.edu
Contact: Abel Huang, BS 415-514-9011 abel.huang@ucsf.edu

Locations
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United States, California
Zuckerberg San Francisco General Hospital
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Suzaynn F Schick University of California, San Francisco
More Information
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT06030674    
Other Study ID Numbers: T32IR4867
First Posted: September 11, 2023    Key Record Dates
Last Update Posted: September 11, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
Nonsmokers
Secondhand cannabis smoke
Environmental cannabis
Exposure
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders