Melanin and Dermal Uptake of Thirdhand Cigarette Smoke

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Melanin and Dermal Uptake of Thirdhand Cigarette Smoke

Conditions
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Healthy

Intervention / Treatment
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* Other: Wear clothing that has been exposed to cigarette smoke for 3 hours.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Dermal uptake, metabolism and excretion of nicotine in participants with high and low levels of dermal melanin will be compared.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low melanin<br>Individuals with skin reflectance scores below 150 using the Mexameter 18 instrument. | Other: Wear clothing that has been exposed to cigarette smoke for 3 hours.<br>* 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.<br>|
| Experimental: High melanin<br>Individuals with skin reflectance scores above 249 using the Mexameter 18 instrument | Other: Wear clothing that has been exposed to cigarette smoke for 3 hours.<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thirdhand tobacco smoke, Dermal, Exposure, Tobacco Smoke Pollution, Melanin, Nicotine