Status:
UNKNOWN
Melanin and Dermal Uptake of Thirdhand Cigarette Smoke
Lead Sponsor:
University of California, San Francisco
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
This is a pilot study of the effects of dermal melanin on dermal uptake and retention of nicotine. The initial hypothesis is that higher levels of dermal melanin will correlate with lower uptake and l...
Detailed Description
This is an interventional pharmacokinetic study comparing the uptake and metabolism of nicotine from smoke-exposed clothing in people with low high levels of dermal melanin and people with high levels...
Eligibility Criteria
Inclusion
- Adult nonsmoker
- Aged 18-50
- Skin reflectance scores below 150 or above 249 using the Mexameter 18 instrument
- Healthy on the basis of medical history
- Systolic blood pressure \<150
- Diastolic blood pressure \<100
- C-reactive protein \<3.1 mg/ml
- Liver function (AST and ALT) in normal ranges
- kidney function (BUN) in normal ranges
- LDL\<131
- Blood glucose \<110
- Not exposed to tobacco SHS.
Exclusion
- Dermal skin reflectance score between 150 and 249, as measured by the Mexameter 18 instrument.
- 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 greater than or equal to 150
- Diastolic blood pressure greater than or equal to 100
- Blood glucose greater than or equal to 110
- LDL greater than or equal to130
- 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 3 months
- Unable to hold allergy or other OTC medicines
- Occupational exposure to smoke, dusts OR fumes
- Concurrent participation in another clinical trial
- Unable to communicate in English
- No social security number
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06020248
Start Date
September 1 2023
End Date
November 1 2025
Last Update
September 6 2023
Active Locations (1)
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1
Zuckerberg San Francisco General Hospital
San Francisco, California, United States, 94110