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

Primary Purpose

Healthy

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Secondhand cannabis emissions/smoke exposure
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy focused on measuring Nonsmokers, Secondhand cannabis smoke, Environmental cannabis, Exposure

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Zuckerberg San Francisco General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exposure to secondhand cannabis smoke in public places

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 25, 2023
Last Updated
September 1, 2023
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT06030674
Brief Title
Measuring Environmental Tobacco and Cannabis: Pollutants and Exposures
Acronym
CAN03
Official Title
Measuring Environmental Tobacco and Cannabis: Pollutants and Exposures
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Nonsmokers, Secondhand cannabis smoke, Environmental cannabis, Exposure

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exposure to secondhand cannabis smoke in public places
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Secondhand cannabis emissions/smoke exposure
Intervention Description
This is an environmental exposure performed in public places where people are consuming cannabis.
Primary Outcome Measure Information:
Title
Change in the concentration of urinary cannabinoid metabolites in health nonsmokers exposed to cannabis smoke and emissions
Description
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.
Time Frame
Baseline (before exposure) and the morning after exposure, up to 22 hours.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suzaynn F Schick, Phd
Phone
4155143535
Email
suzaynn.schick@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Abel Huang, BS
Phone
415-514-9011
Email
abel.huang@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzaynn F Schick
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zuckerberg San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Measuring Environmental Tobacco and Cannabis: Pollutants and Exposures

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