SmokingNCT04090606
Tobacco Constituents and Biomarkers
An observational study of Smoking, run by Masonic Cancer Center, University of Minnesota.
Trial summary
This proposal addresses several research priorities related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products as mandated by the Family Smoking Prevention and Tobacco Control Act. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- FTC Method Smoking Regimen, Massachusetts Method Smoking Regimen and Health Canada Intense Smoking Regimen
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to 22 Mar 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult smokers from Minneapolis-St. Paul metro area
Who may be able to join
- Male or female adult smokers 18-65 years of age, who smoke at least 7 cigarettes per day (to assure that biomarker levels are above the limit of quantitation) and do not have plans to quit smoking in the next month;
- Smoked the same brand for >80% of their cigarettes over the course of at least 1 year, and smoked not more than 20 cigarettes (1 pack) of a different brand within two weeks prior to the eligibility screening;
- Not using any other nicotine or tobacco product;
- Subjects who are not taking any medications that affect relevant metabolic enzymes;
- Women who are not pregnant or nursing;
- Subjects have provided written informed consent to participate in the study (adolescents under the age of 18 will be excluded because this project involves use of tobacco products).
Who cannot join
- Significant immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data;
- Current or recent alcohol or drug abuse problems (to ensure alcohol and drug use does not affect biomarkers of exposure and to maximize retention);
- Regular tobacco use (e.g., greater than weekly) other than cigarettes;
- Currently using nicotine replacement or other tobacco cessation products (to minimize confounding effects of another product);
- Pregnant or breastfeeding (due to toxic effects from tobacco products)
- Report smoking more than 1 pack (20 cigarettes) of a non-usual brand cigarette in the past two weeks * Participants who report smoking 2 or more non-usual brand cigarettes the day before the clinic visit will be ineligible
About this study
Official title: Constituent Yields and Biomarkers of Exposure for Tobacco Product Regulation
This proposal addresses several research priorities related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products as mandated by the Family Smoking Prevention and Tobacco Control Act. Scientific evidence supports the important role of tobacco and cigarette smoke carcinogens in the development of cancers associated with cigarette smoking. Regulation of the levels of harmful constituents in cigarette smoke is one of the tobacco control strategies that now can be employed by the FDA and may serve to reduce tobacco carcinogen exposures in those smokers who are unable or unwilling to quit smoking. Such regulation will require a valid and robust approach to the assessment of comparative toxicity and carcinogenicity among various cigarette brands. This proposal will help develop a testing approach that can produce meaningful predictions of changes in human exposure due to changes in constituent levels in cigarette smoke, and hence serve as a reliable measure for product regulation. Thus, the proposed research will generate findings and data that are directly relevant to inform the FDA's regulation of the manufacture, distribution, and marketing of tobacco products to protect public health. The human trial deals with Aims 2 and 3 of this study.
- Conditions
- Smoking
- Being tested
- FTC Method Smoking Regimen, Massachusetts Method Smoking Regimen, Health Canada Intense Smoking Regimen
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FTC Method Smoking RegimenOther
cigarettes are smoked by drawing 35 mL puff volumes over 2 s, with 60 s interval between puffs and no blocking of filter ventilation holes
Massachusetts Method Smoking RegimenOther
45-mL puffs drawn over 2 s, with 30 s interval between puffs and 50% blocking of filter ventilation holes
Health Canada Intense Smoking RegimenOther
55-mL puff volumes of 2-s duration, with 30 s interval between puffs and 100% blocking of filter ventilation holes
| Study group | Role | What they receive |
|---|---|---|
| FTC Method | Not described Receives: Other: FTC Method Smoking Regimen | |
| Massachusetts Method | Not described Receives: Other: Massachusetts Method Smoking Regimen | |
| Health Canada Intense Method | Not described Receives: Other: Health Canada Intense Smoking Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
The extent to which differences in smoke yields of NNN and NNK per mg nicotine are predictive of differences in smokers' exposure to these carcinogens (human trial)
Correlation between urinary total NNN and total NNAL (with and without normalization for total nicotine intake) in smokers and the machine-measured yields of NNN and NNK (per mg nicotine and per cigarette) in cigarettes smoked by these individuals. The relationship will be investigated for the machine-measured yields generated by 3 different smoking regimens.
Measured: 1 Year
The extent to which NNN and NNK per mg nicotine levels in spent cigarette filters are predictive of differences in smokers' exposure to these carcinogens (human trial)
Correlation, for each smoker, between the TSNA per mg nicotine content in their spent cigarette filters with the levels of total NNN and total NNAL per nicotine equivalents in their urine
Measured: 1 Year
Secondary outcomes (2)
Individual factors affecting TSNA per mg nicotine and exposures in smokers (human trial)
Correlation (if any) of individual factors and the relationship between the machine-measured TSNA per mg nicotine and exposures in smokers.
Measured: 1 Year
Relationship between 1-HOP and TSNA per mg Nicotine
Correlation between urinary biomarker of polycyclic aromatic hydrocarbon exposure (1-HOP) and TSNA per mg nicotine yields in cigarette smoke.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study startDec 2013
- Primary completion22 Mar 2021
- Study completion22 Mar 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.
- More trials run by Masonic Cancer Center, 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04090606
- Sponsor's protocol ID
- 2013NTLS115
- Status last verified
- Aug 2021
- First submitted
- 10 Sep 2019
- Last updated
- 11 Aug 2021
- 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 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Constituent Yields and Biomarkers of Exposure for Tobacco Product Regulation
- ClinicalTrials.gov ID
- NCT04090606
- Acronym / sponsor ID
- 2013NTLS115
- Conditions
- Smoking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Dec 2013 (actual)
- Primary completion
- 22 Mar 2021 (actual)
- Study completion
- 22 Mar 2021 (actual)
- First posted
- 16 Sep 2019 (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 proposal addresses several research priorities related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products as mandated by the Family Smoking Prevention and Tobacco Control Act. Scientific evidence supports the important role of tobacco and cigarette smoke carcinogens in the development of cancers associated with cigarette smoking. Regulation of the levels of harmful constituents in cigarette smoke is one of the tobacco control strategies that now can be employed by the FDA and may serve to reduce tobacco carcinogen exposures in those smokers who are unable or unwilling to quit smoking. Such regulation will require a valid and robust approach to the assessment of comparative toxicity and carcinogenicity among various cigarette brands. This proposal will help develop a testing approach that can produce meaningful predictions of changes in human exposure due to changes in constituent levels in cigarette smoke, and hence serve as a reliable measure for product regulation. Thus, the proposed research will generate findings and data that are directly relevant to inform the FDA's regulation of the manufacture, distribution, and marketing of tobacco products to protect public health. The human trial deals with Aims 2 and 3 of this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FTC Method | – | Other: FTC Method Smoking Regimen |
| Massachusetts Method | – | Other: Massachusetts Method Smoking Regimen |
| Health Canada Intense Method | – | Other: Health Canada Intense Smoking Regimen |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult smokers from Minneapolis-St. Paul metro area
Key inclusion criteria (6 listed)
- Male or female adult smokers 18-65 years of age, who smoke at least 7 cigarettes per day (to assure that biomarker levels are above the limit of quantitation) and do not have plans to quit smoking in the next month;
- Smoked the same brand for >80% of their cigarettes over the course of at least 1 year, and smoked not more than 20 cigarettes (1 pack) of a different brand within two weeks prior to the eligibility screening;
- Not using any other nicotine or tobacco product;
- Subjects who are not taking any medications that affect relevant metabolic enzymes;
- Women who are not pregnant or nursing;
Key exclusion criteria (6 listed)
- Significant immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data;
- Current or recent alcohol or drug abuse problems (to ensure alcohol and drug use does not affect biomarkers of exposure and to maximize retention);
- Regular tobacco use (e.g., greater than weekly) other than cigarettes;
- Currently using nicotine replacement or other tobacco cessation products (to minimize confounding effects of another product);
- Pregnant or breastfeeding (due to toxic effects from tobacco products)
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 |
|---|---|---|
| FTC Method Smoking Regimencigarettes are smoked by drawing 35 mL puff volumes over 2 s, with 60 s interval between puffs and no blocking of filter ventilation holes | Other | FTC Method |
| Massachusetts Method Smoking Regimen45-mL puffs drawn over 2 s, with 30 s interval between puffs and 50% blocking of filter ventilation holes | Other | Massachusetts Method |
| Health Canada Intense Smoking Regimen55-mL puff volumes of 2-s duration, with 30 s interval between puffs and 100% blocking of filter ventilation holes | Other | Health Canada Intense Method |
Primary outcome
The extent to which differences in smoke yields of NNN and NNK per mg nicotine are predictive of differences in smokers' exposure to these carcinogens (human trial)
Time frame: 1 Year
Correlation between urinary total NNN and total NNAL (with and without normalization for total nicotine intake) in smokers and the machine-measured yields of NNN and NNK (per mg nicotine and per cigarette) in cigarettes smoked by these individuals. The relationship will be investigated for the machine-measured yields generated by 3 different smoking regimens.
The extent to which NNN and NNK per mg nicotine levels in spent cigarette filters are predictive of differences in smokers' exposure to these carcinogens (human trial)
Time frame: 1 Year
Correlation, for each smoker, between the TSNA per mg nicotine content in their spent cigarette filters with the levels of total NNN and total NNAL per nicotine equivalents in their urine
2 secondary outcomes
Individual factors affecting TSNA per mg nicotine and exposures in smokers (human trial)
Time frame: 1 Year
Relationship between 1-HOP and TSNA per mg Nicotine
Time frame: 1 Year
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 11 Aug 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking, run by Masonic Cancer Center, 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 6 inclusion and 6 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 11 Aug 2021. 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 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?
The extent to which differences in smoke yields of NNN and NNK per mg nicotine are predictive of differences in smokers' exposure to these carcinogens (human trial) (time frame: 1 Year). 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 11 Aug 2021.