xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06030674</url>
    </required_header>
    <id_info>
      <org_study_id>T32IR4867</org_study_id>
      <nct_id>NCT06030674</nct_id>
    </id_info>
    <brief_title>Measuring Environmental Tobacco and Cannabis: Pollutants and Exposures</brief_title>
    <acronym>CAN03</acronym>
    <official_title>Measuring Environmental Tobacco and Cannabis: Pollutants and Exposures</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of California, San Francisco</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of California, San Francisco</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is an unblinded pilot study of an environmental exposure to secondhand cannabis smoke in&#xD;
        one group of healthy nonsmokers.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The goal is to gather accurate information on uptake of smoke toxicants from cannabis&#xD;
        exposures in the real world. The investigators will be taking healthy nonsmokers to public&#xD;
        places where people are consuming cannabis and measuring their uptake of cannabinoids.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>This is an unblinded pilot study of an environmental exposure in one group.</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>The exposure cannot be masked or blinded. Data analysts and chemists will be blinded.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change in the concentration of urinary cannabinoid metabolites in health nonsmokers exposed to cannabis smoke and emissions</measure>
      <time_frame>Baseline (before exposure) and the morning after exposure, up to 22 hours.</time_frame>
      <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.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>Exposure to secondhand cannabis smoke in public places</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Secondhand cannabis emissions/smoke exposure</intervention_name>
      <description>This is an environmental exposure performed in public places where people are consuming cannabis.</description>
      <arm_group_label>Exposure to secondhand cannabis smoke in public places</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          -&#xD;
  &#xD;
          Adult nonsmokers, aged 21-50, who:&#xD;
  &#xD;
            -  Are healthy on the basis of medical history&#xD;
  &#xD;
            -  Have systolic blood pressure &lt;150&#xD;
  &#xD;
            -  Have diastolic blood pressure &lt;100&#xD;
  &#xD;
            -  Have BMI between 18.1 and 34.9&#xD;
  &#xD;
            -  Able to perform moderate exercise,&#xD;
  &#xD;
            -  Are not exposed to tobacco or cannabis SHS in their daily lives. (Nonsmoking status&#xD;
               and low SHS exposure are determined by self-report on the screening questionnaire,&#xD;
               salivary cotinine &lt; 10 ng/ml and THC &lt; 50 ng/m and exhaled CO2 below 4 ppm)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Current use of cannabis products, including CBD and edible THC products&#xD;
  &#xD;
            -  Regular exposure to secondhand tobacco or cannabis smoke&#xD;
  &#xD;
            -  Positive SARS-CoV-2 antibody test&#xD;
  &#xD;
            -  Age 18 &lt; or &gt; 50&#xD;
  &#xD;
            -  Physician diagnosis of asthma, heart disease, hypertension, thyroid disease, diabetes,&#xD;
               renal or liver impairment or glaucoma.&#xD;
  &#xD;
            -  Unstable psychiatric condition (such as current major depression, history of&#xD;
               schizophrenia or bipolar disorder) or current use of more than two psychiatric&#xD;
               medications&#xD;
  &#xD;
            -  Systolic blood pressure &gt; 150&#xD;
  &#xD;
            -  Diastolic blood pressure &gt; 100&#xD;
  &#xD;
            -  Pregnancy or breastfeeding (by urine hCG and/or history)&#xD;
  &#xD;
            -  Alcohol or illicit drug dependence within the past 5 years&#xD;
  &#xD;
            -  BMI &gt; 35 and &lt; 18&#xD;
  &#xD;
            -  Current illicit drug use (by history or urine test)&#xD;
  &#xD;
            -  More than 1 pack year smoking history&#xD;
  &#xD;
            -  Ever a daily marijuana smoker&#xD;
  &#xD;
            -  Smoked anything within the last 2 months&#xD;
  &#xD;
            -  Occupational exposure to smoke, dusts OR fumes&#xD;
  &#xD;
            -  Concurrent participation in another clinical trial&#xD;
  &#xD;
            -  Unable to communicate in English&#xD;
  &#xD;
            -  No social security number&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Suzaynn F Schick</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of California, San Francisco</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Suzaynn F Schick, Phd</last_name>
      <phone>4155143535</phone>
      <email>suzaynn.schick@ucsf.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Abel Huang, BS</last_name>
      <phone>415-514-9011</phone>
      <email>abel.huang@ucsf.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Zuckerberg San Francisco General Hospital</name>
        <address>
          <city>San Francisco</city>
          <state>California</state>
          <zip>94110</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Nonsmokers</keyword>
    <keyword>Secondhand cannabis smoke</keyword>
    <keyword>Environmental cannabis</keyword>
    <keyword>Exposure</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Marijuana Abuse</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06030674
  org study id: T32IR4867
  nct id: NCT06030674
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is an unblinded pilot study of an environmental exposure to secondhand cannabis smoke in
        one group of healthy nonsmokers.
  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.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: This is an unblinded pilot study of an environmental exposure in one group.
  primary purpose: Basic Science
  masking: None (Open Label)
  masking description: The exposure cannot be masked or blinded. Data analysts and chemists will be blinded.
  measure: 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.
  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.
  arm group label: Exposure to secondhand cannabis smoke in public places
  arm group type: Experimental
  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: Secondhand cannabis emissions/smoke exposure
  description: This is an environmental exposure performed in public places where people are consuming cannabis.
  arm group label: Exposure to secondhand cannabis smoke in public places
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Suzaynn F Schick
  role: Principal Investigator
  affiliation: University of California, San Francisco
  last name: Suzaynn F Schick, Phd
  phone: 4155143535
  email: suzaynn.schick@ucsf.edu
  last name: Abel Huang, BS
  phone: 415-514-9011
  email: abel.huang@ucsf.edu
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Marijuana Abuse
  sharing ipd: No