e-Cigarettes: Formaldehyde DNA Adducts, Oxidative Damage, and Potential Toxicity and Carcinogenesis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Minnesota
- Enrollment
- 217
- Locations
- 1
- Primary Endpoint
- DNA Adducts
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
DNA Adducts
Time Frame: 6 months
Formation of Formaldehyde DNA Adducts in oral cells before and after smoking or vaping
Secondary Outcomes
- TNE(6 months)
- Urinary 8-iso-PGF-2α(6 months)
- Urinary PGEM(6 months)
- C-reactive protein(6 months)