SmokersNCT06983392
Persistence of Oral DNA Adducts in Smokers and Vapers
A study testing Abstain from smoking/vaping in people with Smokers and Vaping, run by University of Minnesota.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smokers, Vaping, Healthy Volunteers
- What is being tested?
- Abstain from smoking/vaping
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 30 Jul 2030
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant or nursing
- High blood pressure
- Unstable health condition(s)
- History of cancer or liver disease
About this study
Official title: Levels and Persistence of Oral DNA Adducts in Smokers, Vapers, and Non-users
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.
Read the 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.
- Conditions
- Smokers, Vaping, Healthy Volunteers
- Being tested
- Abstain from smoking/vaping
- Keywords
- smoking, vaping, tobacco, nicotine, abstain
- Medical subject headings
- Vaping, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abstain from smoking/vapingBehavioural
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 | Role | What they receive |
|---|---|---|
| Study group | Experimental | Abstain from product use (either smoking cigarettes or vaping) Receives: Behavioral: Abstain from smoking/vaping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Propylene glycol and glycerol will be measured in the urine of participants to confirm if they vaped during the study. The concentration of these compounds will be reported as pmol/mL urine.
Measured: Vaping markers will be measured in the urine at baseline and Days 3, 6, 12 and 21 after stopping or continuing use.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start1 Mar 2026 (estimated)
- Primary completion30 Jul 2029 (estimated)
- Study completion30 Jul 2030 (estimated)
Why it stopped: No longer funded and not moving forward
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokersStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Hecht, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983392
- Sponsor's protocol ID
- 2025LS003
- Status last verified
- Feb 2026
- First submitted
- 14 Apr 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levels and Persistence of Oral DNA Adducts in Smokers, Vapers, and Non-users
- ClinicalTrials.gov ID
- NCT06983392
- Acronym / sponsor ID
- 2025LS003
- Conditions
- Smokers, Vaping, Healthy Volunteers
- Keywords
- smoking, vaping, tobacco, nicotine, abstain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No longer funded and not moving forward
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 30 Jul 2029 (estimated)
- Study completion
- 30 Jul 2030 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Behavioral: Abstain from smoking/vapingAbstain from product use (either smoking cigarettes or vaping) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnant or nursing
- High blood pressure
- Unstable health condition(s)
- History of cancer or liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abstain from smoking/vapingThey 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. | Behavioural | Study group |
Primary outcome
Oral DNA damage (adduct) levels
Time frame: DNA damage will be assessed at baseline and Days 3, 6, 12, and 21 after stopping use or continuing use
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.
Urinary smoking markers
Time frame: Urine levels will be measured at baseline and Days 3, 6, 12, and 21 after stopping use or continuing use.
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
1 secondary outcome
Urinary vape markers
Time frame: Vaping markers will be measured in the urine at baseline and Days 3, 6, 12 and 21 after stopping or continuing use.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Hecht principal investigator
University of Minnesota
Questions about this trial
What is this clinical trial studying?
A study testing Abstain from smoking/vaping in people with Smokers and Vaping, run by University of Minnesota.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral DNA damage (adduct) levels (time frame: DNA damage will be assessed at baseline and Days 3, 6, 12, and 21 after stopping use or continuing use). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.