e-Cigarette - DNA Adducts

Study Overview
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Brief Summary
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This study will examine the level of toxicity of e-cigarette use compared to smokers and nonsmokers including inflammation markers, toxicant and carcinogen exposure. Additionally, the study will look at the effect of varying voltage levels for e-cigarette users.

Detailed Description
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In this observational study, e-cigarette users, smokers, and non-users of e-cigarette or tobacco products (up to 134 per group) will be recruited from the Minneapolis-St. Paul area. This research will be conducted at the Tobacco Research Programs at the University of Minnesota. Subjects are screened for eligibility over the phone. If eligible after the phone screen, participants will be invited to attend orientation screening visit in the clinic where consent will be obtained and subjects will complete forms about their tobacco and e-cigarette use and medical history. Subjects who eligible will be asked to return for six visits over the course of six months. At these appointments, subjects will provide biological specimen samples (buccal cells, urine and blood). Saliva will be collected before and after a smoking or vaping session. Non-users will only have 1 saliva collection. Subjects will be asked for information pertaining to and e-cigarette and tobacco use and overall health.

Official Title
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e-Cigarettes: Formaldehyde DNA Adducts, Oxidative Damage, and Potential Toxicity and Carcinogenesis

Conditions
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Smoking, Cigarette Smoking, Electronic Cigarettes

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Good physical health with no unstable medical conditions; Able to provide written informed consent; Stable and good mental health; Meet criteria for 1 of three groups: Regular smokers confirmed by CO; E-cigarette users (exclusive e-cigarette use for 3 months); Non-Tobacco Users Non-smokers Exclusion Criteria: Unstable medical condition Not willing to attend visits

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Smokers<br> | |
| E-cigarette users<br> | |
| Non-smokers<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DNA Adducts | Formation of Formaldehyde DNA Adducts in oral cells before and after smoking or vaping | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary 8-iso-PGF-2α | Stability of Urinary 8-iso-PGF-2α (biomarkers of oxidative damage) over a 6-month sample period | 6 months | 
| Urinary PGEM | Stability of Urinary PGEM (biomarker of inflammation) over a 6-month sample period | 6 months | 
| C-reactive protein | Stability of C-reactive protein in serum (biomarker of inflammation) over a 6-month sample period | 6 months | 
| TNE | Total Nicotine Equivalents (nicotine exposure) over a 6-month sample period | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tobacco, E-Cigarettes, Toxicants, Formaldehyde DNA Adducts, Oxidative Damage