Persistence of Oral DNA Adducts in Smokers and Vapers

NCT06983392 | Withdrawn

• 1 other identifier: 2025LS003
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to better understand what damage caused to oral cells from smoking and vaping might be important in the formation of oral cancers. We will compare levels of DNA damage between those asked to stop smoking or vaping to those who continue to smoke or vape and those who never use tobacco or nicotine products. The goal is to identify damage that is found at higher levels or remains in the oral cells longer because they might be more important in causing cancer than other types of damage.

Conditions

Smokers; Vaping; Healthy Volunteers

Keywords

smoking; vaping; tobacco; nicotine; abstain

Outcome Measures

Primary Outcomes (2)

• Oral DNA damage (adduct) levels

  The levels and types of DNA damage (adducts) will be measured in the oral cells of all participants. DNA adducts will be reported as fmol/umol dG or as # adducts / 10\^8 nucleotides. DNA adduct levels will be compared between those who continue to use their products, those who stop using their products, and those who never use tobacco or nicotine products. The goal is to identify DNA damage that is found at higher levels or remains in the oral cells longer because they might be more important in causing cancer than other types of DNA damage.

  DNA damage will be assessed at baseline and Days 3, 6, 12, and 21 after stopping use or continuing use

• Urinary smoking markers

  Total nicotine equivalents (TNE), cyanoethyl mercapturic acid (CEMA), and NNAL will be measured in the urine of participants to confirm if they smoked during the study. The concentration of these compounds will be reported at pmol/mL urine

  Urine levels will be measured at baseline and Days 3, 6, 12, and 21 after stopping use or continuing use.

Secondary Outcomes (1)

• Urinary vape markers

  Vaping markers will be measured in the urine at baseline and Days 3, 6, 12 and 21 after stopping or continuing use.

Study Arms (1)

Study group

EXPERIMENTAL

Abstain from product use (either smoking cigarettes or vaping)

Behavioral: Abstain from smoking/vaping

Interventions

Abstain from smoking/vaping BEHAVIORAL

They may be asked to stop smoking cigarettes or vaping during the study for 21 days. If they are asked to abstain from their product use they will be given nicotine patches and/or lozenges to help with abstinence during the study.

Study group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + years old
• Good physical and mental health
• Stable physical and mental health
• Either 1) smokes cigarettes daily, 2) vapes daily, 3) does not use any tobacco or nicotine products

You may not qualify if:

• Pregnant or nursing
• High blood pressure
• Unstable health condition(s)
• History of cancer or liver disease

Sponsors & Collaborators

• University of Minnesota: lead

MeSH Terms

Conditions

Vaping; Smoking

Interventions

Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Stephen Hecht

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be asked to fill out study questionnaires and attend six in-person study visits to provide saliva, mouth cells, cheek cells, and urine. They will not be able to eat or drink anything other than water for at least 1 hour before your study visits. They may be asked to stop smoking cigarettes or vaping during the study for 21 days. If they are asked to abstain from their product use they will be given nicotine patches and/or lozenges to help with abstinence during the study.

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: May 21, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): July 30, 2029
• Study Completion (Estimated): July 30, 2030
• Last Updated: February 13, 2026

Record last verified: 2026-02