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Recruiting NCT06030674

Measuring Environmental Tobacco and Cannabis: Pollutants and Exposures

No phase Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Secondhand cannabis emissions/smoke exposure.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 21 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other Secondhand cannabis emissions/smoke exposure
    This is an environmental exposure performed in public places where people are consuming cannabis.

Primary outcome measures

  • 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.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Zuckerberg San Francisco General Hospital — San Francisco

Identifiers

NCT: NCT06030674 · T32IR4867

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗