Melanin and Dermal Uptake of Thirdhand Cigarette Smoke

NCT ID: NCT06020248

Last Updated: 2023-09-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-30
• Study Completion Date: 2025-11-30

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Low melanin

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

High melanin

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suzaynn F Schick, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Zuckerberg San Francisco General Hospital

San Francisco, California, United States

Countries

United States

Central Contacts

Suzaynn F Schick, PhD

Role: CONTACT

suzaynn@gmail.com

415-514-3535

Abel Huang, BS

Role: CONTACT

abel.huang@ucsf.edu

(415) 514-9011

Other Identifiers

22-37861

Identifier Type: -

Identifier Source: org_study_id