Clinical trial NCT06020248: Melanin and Dermal Uptake of Thirdhand Cigarette Smoke
Official title: Melanin and Dermal Uptake of Thirdhand Cigarette Smoke
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Thirdhand tobacco smoke
Dermal
Exposure
Tobacco Smoke Pollution
Melanin
Nicotine
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Dermal uptake, metabolism and excretion of nicotine in participants with high and low levels of dermal melanin will be compared.
Primary purpose: BASIC_SCIENCE

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 longer retention of nicotine in the skin and body.

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 of dermal melanin. The study will measure nicotine and metabolites of nicotine in the blood during exposure and in urine for 10 days after exposure.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Change in blood concentrations of nicotine
timeFrame: Baseline and 3 hours
measure: Total combined urinary concentrations of the nicotine metabolites cotinine and 3-hydroxycotinine
timeFrame: First void, collected for 10 days
Secondary outcomes:
measure: Urinary concentration of the NNK metabolite NNAL
timeFrame: First void, collected for 10 days
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Zuckerberg San Francisco General Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Suzaynn F Schick, PhD
role: PRINCIPAL_INVESTIGATOR
References: