Melanin and Dermal Uptake of Thirdhand Cigarette Smoke

Healthy Clinical Trial

— THS05  

Official title:

Melanin and Dermal Uptake of Thirdhand Cigarette Smoke

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06020248
• Other study ID #: 22-37861
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2023
• Est. completion date: November 2025

Study information

• Verified date: September 2023
• Source: University of California, San Francisco
• Contact: Suzaynn F Schick, PhD
• Phone: 415-514-3535
• Email: suzaynn[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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.

Locations

Country	Name	City	State
United States	Zuckerberg San Francisco General Hospital	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	First void, collected for 10 days