e-Cigarette - DNA Adducts

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

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.

Study Overview

• Status: Completed
• Conditions: Smoking; Cigarette Smoking; Electronic Cigarettes

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 Type: Observational
• Enrollment (Actual): 217

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited locally within reasonable distance from the University of Minnesota.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Non-smokers
Smokers
E-cigarette users

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Stephen Hecht, Phd, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2017
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: September 13, 2017
• First Submitted That Met QC Criteria: September 13, 2017
• First Posted (Actual): September 15, 2017

Study Record Updates

• Last Update Posted (Actual): November 9, 2022
• Last Update Submitted That Met QC Criteria: November 8, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Tobacco; E-Cigarettes; Oxidative Damage; Toxicants; Formaldehyde DNA Adducts
• Other Study ID Numbers: 2017NTLS040

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No