NCT03284632

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
217

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 11, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

November 9, 2022

Status Verified

November 1, 2022

Enrollment Period

3.9 years

First QC Date

September 13, 2017

Last Update Submit

November 8, 2022

Conditions

SmokingCigarette SmokingElectronic Cigarettes

Keywords

TobaccoE-CigarettesToxicantsFormaldehyde DNA AdductsOxidative Damage

Outcome Measures

Primary Outcomes (1)

  • DNA Adducts

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

    6 months

Secondary Outcomes (4)

  • Urinary 8-iso-PGF-2α

    6 months

  • Urinary PGEM

    6 months

  • C-reactive protein

    6 months

  • TNE

    6 months

Study Arms (3)

Smokers

E-cigarette users

Non-smokers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Unstable medical condition Not willing to attend visits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Buffy Coat, Serum, Plasma, Urine, Buccal Cells, Saliva

MeSH Terms

Conditions

SmokingCigarette SmokingVaping

Condition Hierarchy (Ancestors)

BehaviorTobacco SmokingTobacco Use

Study Officials

  • Stephen Hecht, Phd

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2017

First Posted

September 15, 2017

Study Start

July 11, 2017

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

November 9, 2022

Record last verified: 2022-11

Locations

US(1)