Melanin and Dermal Uptake of Thirdhand Cigarette Smoke

NCT06020248 | Unknown

• 1 other identifier: 22-37861
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Thirdhand tobacco smoke; Dermal; Exposure; Tobacco Smoke Pollution; Melanin; Nicotine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Urinary concentration of the NNK metabolite NNAL

  First void, collected for 10 days

Study Arms (2)

Low melanin

EXPERIMENTAL

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.

High melanin

EXPERIMENTAL

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.

Interventions

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Study Officials

• Suzaynn F Schick, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suzaynn F Schick, PhD

CONTACT

415-514-3535; suzaynn@gmail.com

Abel Huang, BS

CONTACT

(415) 514-9011; abel.huang@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Smoke exposure is impossible to mask and team is too small to mask data analysis until later stages.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Dermal uptake, metabolism and excretion of nicotine in participants with high and low levels of dermal melanin will be compared.

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: August 31, 2023
• Study Start: September 1, 2023
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)