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Recruiting NCT06020248

Melanin and Dermal Uptake of Thirdhand Cigarette Smoke

No phase Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Wear clothing that has been exposed to cigarette smoke for 3 hours..
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other Wear clothing that has been exposed to cigarette smoke for 3 hours.
    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.

Primary outcome measures

  • Change in blood concentrations of nicotine [Time frame: Baseline and 3 hours]
  • Total combined urinary concentrations of the nicotine metabolites cotinine and 3-hydroxycotinine [Time frame: First void, collected for 10 days]
Secondary outcome measures (1)
  • Urinary concentration of the NNK metabolite NNAL [Time frame: First void, collected for 10 days]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Zuckerberg San Francisco General Hospital — San Francisco

Identifiers

NCT: NCT06020248 · 22-37861

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗