University of Minnesota
Minneapolis, Minnesota, 55414, United States
NCT Number: NCT03284632
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.
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Notify Me18 year and older
All sexes
Observational
Minneapolis, Minnesota, 55414, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Meet criteria for 1 of three groups:
Exclusion criteria
Time frame: 6 months
Formation of Formaldehyde DNA Adducts in oral cells before and after smoking or vaping
Time frame: 6 months
Stability of Urinary 8-iso-PGF-2α (biomarkers of oxidative damage) over a 6-month sample period
Time frame: 6 months
Stability of Urinary PGEM (biomarker of inflammation) over a 6-month sample period
Time frame: 6 months
Stability of C-reactive protein in serum (biomarker of inflammation) over a 6-month sample period
Time frame: 6 months
Total Nicotine Equivalents (nicotine exposure) over a 6-month sample period
University of Minnesota
Other
e-Cigarettes: Formaldehyde DNA Adducts, Oxidative Damage, and Potential Toxicity and Carcinogenesis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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