SmokingNCT03284632
e-Cigarette - DNA Adducts
An observational study of Smoking and Cigarette Smoking, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking, Cigarette Smoking, Electronic Cigarettes
- How many people
- 217 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2017to 1 Jun 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects will be recruited locally within reasonable distance from the University of Minnesota.
Who may be able to join
- 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
Who cannot join
- Unstable medical condition Not willing to attend visits
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55414
About this study
Official title: 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.
Read the 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.
- Conditions
- Smoking, Cigarette Smoking, Electronic Cigarettes
- Keywords
- Tobacco, E-Cigarettes, Toxicants, Formaldehyde DNA Adducts, Oxidative Damage
- Medical subject headings
- Smoking, Cigarette Smoking, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Smokers | Not described | |
| E-cigarette users | Not described | |
| Non-smokers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
DNA Adducts
Formation of Formaldehyde DNA Adducts in oral cells before and after smoking or vaping
Measured: 6 months
Secondary outcomes (4)
Urinary 8-iso-PGF-2α
Stability of Urinary 8-iso-PGF-2α (biomarkers of oxidative damage) over a 6-month sample period
Measured: 6 months
Urinary PGEM
Stability of Urinary PGEM (biomarker of inflammation) over a 6-month sample period
Measured: 6 months
C-reactive protein
Stability of C-reactive protein in serum (biomarker of inflammation) over a 6-month sample period
Measured: 6 months
TNE
Total Nicotine Equivalents (nicotine exposure) over a 6-month sample period
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start11 Jul 2017
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Stephen Hecht, Phd, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03284632
- Sponsor's protocol ID
- 2017NTLS040
- Status last verified
- Nov 2022
- First submitted
- 13 Sep 2017
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- e-Cigarettes: Formaldehyde DNA Adducts, Oxidative Damage, and Potential Toxicity and Carcinogenesis
- ClinicalTrials.gov ID
- NCT03284632
- Acronym / sponsor ID
- 2017NTLS040
- Conditions
- Smoking, Cigarette Smoking, Electronic Cigarettes
- Keywords
- Tobacco, E-Cigarettes, Toxicants, Formaldehyde DNA Adducts, Oxidative Damage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 11 Jul 2017 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 15 Sep 2017 (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 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Smokers | – | – |
| E-cigarette users | – | – |
| Non-smokers | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited locally within reasonable distance from the University of Minnesota.
Key inclusion criteria (5 listed)
- Good physical health with no unstable medical conditions; Able to provide written informed consent; Stable and good mental health;
- Regular smokers confirmed by CO;
- E-cigarette users (exclusive e-cigarette use for 3 months); Non-Tobacco Users
- Non-smokers
Key exclusion criteria (1 listed)
- Unstable medical condition Not willing to attend visits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
DNA Adducts
Time frame: 6 months
Formation of Formaldehyde DNA Adducts in oral cells before and after smoking or vaping
4 secondary outcomes
Urinary 8-iso-PGF-2α
Time frame: 6 months
Urinary PGEM
Time frame: 6 months
C-reactive protein
Time frame: 6 months
TNE
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
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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, Phd principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking and Cigarette Smoking, run by University of Minnesota at 1 site in United States.
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 5 inclusion and 1 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: finished, as of the sponsor's last update on 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
DNA Adducts (time frame: 6 months). 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 9 Nov 2022.