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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low melanin | Experimental | Individuals with skin reflectance scores below 150 using the Mexameter 18 instrument. |
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| High melanin | Experimental | Individuals with skin reflectance scores above 249 using the Mexameter 18 instrument |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wear clothing that has been exposed to cigarette smoke for 3 hours. | Other | Cotton clothing is exposed to smoke from Marlboro Red (hard pack) cigarettes at 1-1.2 mg/m3 repeatedly, until total exposure equals 3 grams total particulate material. When tested after exposure, the clothing typically contained 59.15 +/- 18 µg nicotine and 42 +/- 24 ng NNK per gram. The mass of the clothing varies by size, but the average combination of pants and shirt contains 32 mgs nicotine and 23 µg NNK. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood concentrations of nicotine | The study will measure concentration of nicotine in the blood before and after the dermal exposure to nicotine. | Baseline and 3 hours |
| Total combined urinary concentrations of the nicotine metabolites cotinine and 3-hydroxycotinine | The study will measure urinary metabolites of nicotine in the first void of the day for 10 days after exposure and sum the total mass of metabolites. | First void, collected for 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary concentration of the NNK metabolite NNAL | The study will measure urinary metabolites of NNK in the first void of the day for 10 days after exposure and sum the total mass of metabolites. | First void, collected for 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suzaynn F Schick, PhD | Contact | 415-514-3535 | suzaynn@gmail.com | |
| Abel Huang, BS | Contact | (415) 514-9011 | abel.huang@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Suzaynn F Schick, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zuckerberg San Francisco General Hospital | Recruiting | San Francisco | California | 94110 | United States |
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Dermal uptake, metabolism and excretion of nicotine in participants with high and low levels of dermal melanin will be compared.
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Smoke exposure is impossible to mask and team is too small to mask data analysis until later stages.
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