Melanin and Dermal Uptake of Thirdhand Cigarette Smoke (THS05)

University of California San Francisco (UCSF)

Status: Not yet enrolling

Conditions: Healthy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06020248

22-37861

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Low melanin

Experimental group

Description:

Individuals with skin reflectance scores below 150 using the Mexameter 18 instrument.

Treatment:

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

High melanin

Experimental group

Description:

Individuals with skin reflectance scores above 249 using the Mexameter 18 instrument

Treatment:

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