Smoking Clinical Trial
Official title:
e-Cigarettes: Formaldehyde DNA Adducts, Oxidative Damage, and Potential Toxicity and Carcinogenesis
NCT number | NCT03284632 |
Other study ID # | 2017NTLS040 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 11, 2017 |
Est. completion date | June 1, 2021 |
Verified date | November 2022 |
Source | University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 217 |
Est. completion date | June 1, 2021 |
Est. primary completion date | June 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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: 1. Regular smokers confirmed by CO; 2. E-cigarette users (exclusive e-cigarette use for 3 months); Non-Tobacco Users 3. Non-smokers Exclusion Criteria: - Unstable medical condition Not willing to attend visits |
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota | National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | DNA Adducts | Formation of Formaldehyde DNA Adducts in oral cells before and after smoking or vaping | 6 months | |
Secondary | Urinary 8-iso-PGF-2a | Stability of Urinary 8-iso-PGF-2a (biomarkers of oxidative damage) over a 6-month sample period | 6 months | |
Secondary | Urinary PGEM | Stability of Urinary PGEM (biomarker of inflammation) over a 6-month sample period | 6 months | |
Secondary | C-reactive protein | Stability of C-reactive protein in serum (biomarker of inflammation) over a 6-month sample period | 6 months | |
Secondary | TNE | Total Nicotine Equivalents (nicotine exposure) over a 6-month sample period | 6 months |
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