Healthy
Conditions
Keywords
Nonsmokers, Secondhand cannabis smoke, Environmental cannabis, Exposure
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.
Interventions
OTHERSecondhand cannabis emissions/smoke exposure
This is an environmental exposure performed in public places where people are consuming cannabis.
Sponsors
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
The exposure cannot be masked or blinded. Data analysts and chemists will be blinded.
Intervention model description
This is an unblinded pilot study of an environmental exposure in one group.
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the concentration of urinary cannabinoid metabolites in health nonsmokers exposed to cannabis smoke and emissions | 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. |
Countries
United States
Contacts
CONTACTSuzaynn F Schick, Phd
CONTACTAbel Huang, BS
PRINCIPAL_INVESTIGATORSuzaynn F Schick
University of California, San Francisco
Outcome results
None listed