e-Cigarette - DNA Adducts

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03284632

Enrollment

217

Registered

2017-09-15

Start date

2017-07-11

Completion date

2021-06-01

Last updated

2022-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cigarette Smoking, Electronic Cigarettes, Smoking

Keywords

Tobacco, E-Cigarettes, Toxicants, Formaldehyde DNA Adducts, Oxidative Damage

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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: 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

Design outcomes

Primary

Measure	Time frame	Description
DNA Adducts	6 months	Formation of Formaldehyde DNA Adducts in oral cells before and after smoking or vaping

Secondary

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

Countries

United States

Outcome results