Thirdhand Smoke Exposure for Healthy Subjects

(THS05 Trial)

Overseen By Abel Huang, BS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must not be taking: Psychiatric medications

Disqualifiers: Asthma, Heart disease, Hypertension, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those using more than two psychiatric medications or unable to hold allergy or other over-the-counter medicines.

What data supports the effectiveness of the treatment of wearing clothing exposed to cigarette smoke for healthy subjects?

The research shows that nicotine from cigarette smoke can be absorbed through the skin from clothing, which means that wearing smoke-exposed clothing can lead to nicotine exposure similar to being in a smoking environment. This suggests that the treatment could effectively simulate exposure to cigarette smoke without direct inhalation. ^{1 2 3 4 5}

Is it safe for humans to be exposed to thirdhand smoke through clothing?

Research shows that thirdhand smoke exposure through clothing can lead to significant absorption of nicotine and other harmful chemicals, which may cause oxidative damage and skin inflammation. This suggests potential health risks, especially for children and adults in environments with cigarette smoke residue. ^{1 2 3 5 6}

How does the treatment for thirdhand smoke exposure differ from other treatments?

The treatment for thirdhand smoke exposure is unique because it focuses on reducing exposure to residual tobacco smoke chemicals that persist on surfaces and in the air, unlike other treatments that typically address direct smoking or secondhand smoke exposure. This approach may involve strategies to clean or remediate environments contaminated with thirdhand smoke, which is not a standard treatment for smoking-related conditions. ^{1 2 5 7 8}

What is the purpose of this trial?

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.

Research Team

Suzaynn F Schick, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for healthy adults aged 18-50 with specific skin reflectance scores, normal blood pressure, cholesterol, liver and kidney function. Smokers or those exposed to smoke are excluded, as well as individuals outside the BMI range of 18-35 or with certain medical conditions.

Inclusion Criteria

You are an adult who does not smoke.

According to your medical history, you are in good health.

You have not been exposed to secondhand smoke from tobacco products.

Exclusion Criteria

You have a job where you are regularly exposed to smoke, dust, or fumes.

I do not have an unstable psychiatric condition or use more than two psychiatric medications.

Concurrent participation in another clinical trial

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Exposure

Participants are exposed to smoke-exposed clothing to study dermal uptake and retention of nicotine

1 day

1 visit (in-person)

Monitoring

Blood concentrations of nicotine are measured before and after exposure

3 hours

1 visit (in-person)

Follow-up

Participants are monitored for nicotine metabolites in urine for 10 days after exposure

10 days

Treatment Details

Interventions

• Wear clothing exposed to cigarette smoke

Trial Overview The study investigates how melanin in the skin affects absorption and retention of nicotine from clothes exposed to cigarette smoke. Participants will wear these clothes for three hours to see if more melanin means less nicotine uptake and longer retention.

Participant Groups

Group I: Low melanin Experimental Treatment 1 Intervention

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

Group II: High melanin Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Measurements of dermal uptake of nicotine directly from air and clothing. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Thirdhand cigarette smoke: factors affecting exposure and remediation. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Dermal uptake of nicotine from air and clothing: Experimental verification. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Cotton pillows: A novel field method for assessment of thirdhand smoke pollution. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Identification and determination of the volatile organics of third-hand smoke from different cigarettes and clothing fabrics. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Dermal thirdhand smoke exposure induces oxidative damage, initiates skin inflammatory markers, and adversely alters the human plasma proteome. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Biomarkers of Exposure to Secondhand and Thirdhand Tobacco Smoke: Recent Advances and Future Perspectives. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Detection of third-hand smoke on clothing fibers with a surface acoustic wave gas sensor. [2020]