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OpenTrials
Completed

NCT Number: NCT03284632

e-Cigarette - DNA Adducts

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. DNA Adducts

    Time frame: 6 months

    Formation of Formaldehyde DNA Adducts in oral cells before and after smoking or vaping

Secondary outcomes

  1. Urinary 8-iso-PGF-2α

    Time frame: 6 months

    Stability of Urinary 8-iso-PGF-2α (biomarkers of oxidative damage) over a 6-month sample period

  2. Urinary PGEM

    Time frame: 6 months

    Stability of Urinary PGEM (biomarker of inflammation) over a 6-month sample period

  3. C-reactive protein

    Time frame: 6 months

    Stability of C-reactive protein in serum (biomarker of inflammation) over a 6-month sample period

  4. TNE

    Time frame: 6 months

    Total Nicotine Equivalents (nicotine exposure) over a 6-month sample period

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Sep 15, 2017
Registry last updated
Nov 9, 2022

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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