Melanin and Dermal Uptake of Thirdhand Cigarette Smoke
ConditionHealthy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity of California, San Francisco
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Wear clothing that has been exposed to cigarette smoke for 3 hours.
Other interventionCotton 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Low melaninExperimental treatment 1 intervention
Group B: High melaninExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in blood concentrations of nicotine
The study will measure concentration of nicotine in the blood before and after the dermal exposure to nicotine.
Time frame
Baseline and 3 hours2
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.
Time frame
First void, collected for 10 daysSecondary outcomes
1
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.
Time frame
First void, collected for 10 daysSponsors and contacts
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Source ClinicalTrials.gov