Clinical trial NCT06983392: Persistence of Oral DNA Adducts in Smokers and Vapers
Official title: Levels and Persistence of Oral DNA Adducts in Smokers, Vapers, and Non-users
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Smokers
Vaping
Healthy Volunteers
Keywords: smoking
vaping
tobacco
nicotine
abstain
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: BASIC_SCIENCE

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.

Detailed description: DNA damage (adducts) in the oral cells will be measured in people who smoke and vape while they are using their products regularly for two weeks. Then half of the participants will be asked to stop smoking or vaping. Biological samples (saliva, urine, mouth cells, and cheek cells) will be collected at 6 visits to determine how DNA damage changes in the mouth cells of people asked to stop using their products to those who continue to use their product. The DNA damage in these groups will also be compared to those who do not use tobacco or nicotine products at all. It is believed that DNA damage that remains in the cells longer or that is at higher levels than other DNA damage might be more important to cancer formation.

Eligibility criteria: Inclusion Criteria:

* 21+ 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

Exclusion Criteria:

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

Primary outcomes:
measure: Oral DNA damage (adduct) levels
timeFrame: DNA damage will be assessed at baseline and Days 3, 6, 12, and 21 after stopping use or continuing use
measure: Urinary smoking markers
timeFrame: Urine levels will be measured at baseline and Days 3, 6, 12, and 21 after stopping use or continuing use.
Secondary outcomes:
measure: Urinary vape markers
timeFrame: Vaping markers will be measured in the urine at baseline and Days 3, 6, 12 and 21 after stopping or continuing use.
Other outcomes:
Locations:
Study officials:
affiliation: University of Minnesota
name: Stephen Hecht
role: PRINCIPAL_INVESTIGATOR
References: