SmokingPhase 3NCT03637972
COMET2 Project 1 Filter Ventilation Study
A Phase 3 study testing Ventilated cigarettes only, Unventilated cigarettes only and Access to Experimental Marketplace: Ventilated cigarettes + alternative nicotine delivery systems in people with Smoking and Tobacco Use, run by Masonic Cancer Center, University of Minnesota at 2 sites in United States.
Trial summary
Phase III randomized, 2 x 2 design, open label, multi-center study that will assess the removal of filter ventilation on smoking behavior and biomarkers in a tobacco and nicotine product marketplace simulation of a real world environment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking, Tobacco Use
- What is being tested?
- Ventilated cigarettes only, Unventilated cigarettes only and Access to Experimental Marketplace: Ventilated cigarettes + alternative nicotine delivery systems
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Oct 2018to 9 Dec 2021
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Biochemically confirmed regular cigarette smoker
Who cannot join
- Unstable health
- Unstable medications
- Pregnant or nursing
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
University of Minnesota Tobacco Research Program
Minneapolis, Minnesota, 55414
About this study
Official title: Clinical Trial to Assess the Removal of Filter Ventilation on Smoking Behavior and Biomarkers
Phase III randomized, 2 x 2 design, open label, multi-center study that will assess the removal of filter ventilation on smoking behavior and biomarkers in a tobacco and nicotine product marketplace simulation of a real world environment.
Read the detailed description
This randomized, open label, controlled multi-site study will simulate a "real world" tobacco environment by providing access to an experimental marketplace where they will be given vouchers that can be exchanged for assigned study cigarettes (either ventilated or unventilated) and two of the groups will also have access to non-combusted tobacco/nicotine products.
Subjects (N=550; N=125 in each group) will be randomly assigned to: 1) Ventilated cigarettes only; or 2) Unventilated cigarettes only; 3) Ventilated cigarettes + alternative nicotine delivery systems (ANDS); 4) Unventilated cigarettes + ANDS.
Smokers will undergo an in person screening and then a 12 week experimental trial consisting of 2 weeks of baseline; 2 weeks of usual brand cigarettes in the marketplace and 8 weeks on the study cigarettes in the marketplace, plus a follow-up visit 4 weeks after the intervention is over. The experimental period will simulate a "real world" environment by providing participants with vouchers for a specified number of points that can be exchanged for study cigarettes and/or ANDS. At the end of the study they can exchange unspent points for money.
Biomarker samples (total nicotine equivalents, tobacco specific nitrosamines, volatile organic compound and inflammation markers), smoking topography and inhalation measures are taken at baseline and end of trial.
- Conditions
- Smoking, Tobacco Use
- Being tested
- Ventilated cigarettes only, Unventilated cigarettes only, Access to Experimental Marketplace: Ventilated cigarettes + alternative nicotine delivery systems, Access to Experimental Marketplace: Unventilated cigarettes + ANDS
- Keywords
- Cigarette smoking, Filter Ventilation
- Medical subject headings
- Smoking, Tobacco Use, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilated cigarettes onlyOther
Participants given vouchers that are exchanged for ventilated cigarettes study cigarettes.
Unventilated cigarettes onlyOther
Participants given vouchers that are exchanged for unventilated cigarettes study cigarettes.
Access to Experimental Marketplace: Ventilated cigarettes + alternative nicotine delivery systemsOther
Participants given vouchers that are exchanged for ventilated cigarettes + alternative nicotine delivery systems cigarettes.
Access to Experimental Marketplace: Unventilated cigarettes + ANDSOther
Participants given vouchers that are exchanged for unventilated cigarettes + ANDS.
| Study group | Role | What they receive |
|---|---|---|
| Ventilated cigarettes only | Experimental | Filters with approximately 30-36% filter ventilation Receives: Other: Ventilated cigarettes only |
| Unventilated cigarettes only | Experimental | Filters with approximately 3.0-4.6% filter ventilation Receives: Other: Unventilated cigarettes only |
| Ventilated cigarettes + alternative nicotine delivery systems | Experimental | Filters with approximately 30-36% filter ventilation and access to alternative nicotine delivery systems including e-cigarette/vaping device, medicinal nicotine (lozenge, gum and patch). Receives: Other: Access to Experimental Marketplace: Ventilated cigarettes + alternative nicotine delivery systems |
| Unventilated cigarettes + ANDS | Experimental | Filters with approximately 3.0-4.6% filter ventilation and access to alternative nicotine delivery systems including e-cigarette/vaping device, medicinal nicotine (lozenge, gum and patch). Receives: Other: Access to Experimental Marketplace: Unventilated cigarettes + ANDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total NNAL at Week 8 Visit
The total NNAL at the 8 week visit of Phase 3 adjusted for NNAL at baseline (Phase 2, week 00)
Measured: Week 8
Mean CPD based on 7 day IVR before week 8 visit.
The mean CPD based on 7 days IVR data before week 8 visit adjusted for the mean CPD during Phase 2, week 00.
Measured: Week 8
Secondary outcomes (2)
Change in biomarkers (TNE, NNN, mercapturic acids, PheT) from baseline
Absolute change from baseline in other biomarkers (e.g., TNE, NNN, mercapturic acids, PheT)
Measured: Week 8
Number of cigarette-free days
number of cigarette-free days based on no cigarettes smoked in the previous day on IVR (dropouts with no IVR data are assumed to be smoking)
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start18 Oct 2018
- Primary completion9 Dec 2021
- Study completion9 Dec 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Phase III randomized, open label, multi-center study assessing the impact of filter ventilation. Assigned to ventilated or unventilated cigarettes and either access to ANDS in an experimental marketplace, or no access to ANDS or any other products.
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio State University
- Responsible party
- Sponsor
- Investigators
- Dorothy K Hatsukami, Ph.D, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03637972
- Sponsor's protocol ID
- 2018NTLS083
- Status last verified
- Apr 2022
- First submitted
- 12 Jul 2018
- Last updated
- 29 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Intend to share findings from this research through publications and presentations. Institutions and individuals wishing to access any resources or data must contact the Principal Investigator (Hatsukami). Data generated by this grant will be made to outside investigators, according to NIH Guidance. When data are shared, there will be no limits placed on how the data will be used. Users will agree, however, that the recipient must not transfer the data to other users and that the data are only to be used for research purposes. A record of transfer of data and a copy of the dataset that was distributed will be kept by University of Minnesota.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Assess the Removal of Filter Ventilation on Smoking Behavior and Biomarkers
- ClinicalTrials.gov ID
- NCT03637972
- Acronym / sponsor ID
- 2018NTLS083
- Conditions
- Smoking, Tobacco Use
- Keywords
- Cigarette smoking, Filter Ventilation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Collaborators
- Ohio State University
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- 9 Dec 2021 (actual)
- Study completion
- 9 Dec 2021 (actual)
- First posted
- 20 Aug 2018 (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.
Phase III randomized, 2 x 2 design, open label, multi-center study that will assess the removal of filter ventilation on smoking behavior and biomarkers in a tobacco and nicotine product marketplace simulation of a real world environment.
Detailed description
This randomized, open label, controlled multi-site study will simulate a "real world" tobacco environment by providing access to an experimental marketplace where they will be given vouchers that can be exchanged for assigned study cigarettes (either ventilated or unventilated) and two of the groups will also have access to non-combusted tobacco/nicotine products.
Subjects (N=550; N=125 in each group) will be randomly assigned to: 1) Ventilated cigarettes only; or 2) Unventilated cigarettes only; 3) Ventilated cigarettes + alternative nicotine delivery systems (ANDS); 4) Unventilated cigarettes + ANDS.
Smokers will undergo an in person screening and then a 12 week experimental trial consisting of 2 weeks of baseline; 2 weeks of usual brand cigarettes in the marketplace and 8 weeks on the study cigarettes in the marketplace, plus a follow-up visit 4 weeks after the intervention is over. The experimental period will simulate a "real world" environment by providing participants with vouchers for a specified number of points that can be exchanged for study cigarettes and/or ANDS. At the end of the study they can exchange unspent points for money.
Biomarker samples (total nicotine equivalents, tobacco specific nitrosamines, volatile organic compound and inflammation markers), smoking topography and inhalation measures are taken at baseline and end of trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Phase III randomized, open label, multi-center study assessing the impact of filter ventilation. Assigned to ventilated or unventilated cigarettes and either access to ANDS in an experimental marketplace, or no access to ANDS or any other products.
| Arm | Type | Receives |
|---|---|---|
| Ventilated cigarettes only | Experimental | Other: Ventilated cigarettes onlyFilters with approximately 30-36% filter ventilation |
| Unventilated cigarettes only | Experimental | Other: Unventilated cigarettes onlyFilters with approximately 3.0-4.6% filter ventilation |
| Ventilated cigarettes + alternative nicotine delivery systems | Experimental | Other: Access to Experimental Marketplace: Ventilated cigarettes + alternative nicotine delivery systemsFilters with approximately 30-36% filter ventilation and access to alternative nicotine delivery systems including e-cigarette/vaping device, medicinal nicotine (lozenge, gum and patch). |
| Unventilated cigarettes + ANDS | Experimental | Other: Access to Experimental Marketplace: Unventilated cigarettes + ANDSFilters with approximately 3.0-4.6% filter ventilation and access to alternative nicotine delivery systems including e-cigarette/vaping device, medicinal nicotine (lozenge, gum and patch). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least 18 years of age
- Biochemically confirmed regular cigarette smoker
Key exclusion criteria (3 listed)
- Unstable health
- Unstable medications
- Pregnant or nursing
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 |
|---|---|---|
| Ventilated cigarettes onlyParticipants given vouchers that are exchanged for ventilated cigarettes study cigarettes. | Other | Ventilated cigarettes only |
| Unventilated cigarettes onlyParticipants given vouchers that are exchanged for unventilated cigarettes study cigarettes. | Other | Unventilated cigarettes only |
| Access to Experimental Marketplace: Ventilated cigarettes + alternative nicotine delivery systemsParticipants given vouchers that are exchanged for ventilated cigarettes + alternative nicotine delivery systems cigarettes. | Other | Ventilated cigarettes + alternative nicotine delivery systems |
| Access to Experimental Marketplace: Unventilated cigarettes + ANDSParticipants given vouchers that are exchanged for unventilated cigarettes + ANDS. | Other | Unventilated cigarettes + ANDS |
Primary outcome
The total NNAL at Week 8 Visit
Time frame: Week 8
The total NNAL at the 8 week visit of Phase 3 adjusted for NNAL at baseline (Phase 2, week 00)
Mean CPD based on 7 day IVR before week 8 visit.
Time frame: Week 8
The mean CPD based on 7 days IVR data before week 8 visit adjusted for the mean CPD during Phase 2, week 00.
2 secondary outcomes
Change in biomarkers (TNE, NNN, mercapturic acids, PheT) from baseline
Time frame: Week 8
Number of cigarette-free days
Time frame: Week 8
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 29 Apr 2022.
- Individual participant dataSharing planned: Yes. Intend to share findings from this research through publications and presentations. Institutions and individuals wishing to access any resources or data must contact the Principal Investigator (Hatsukami). Data generated by this grant will be made to outside investigators, according to NIH Guidance. When data are shared, there will be no limits placed on how the data will be used. Users will agree, however, that the recipient must not transfer the data to other users and that the data are only to be used for research purposes. A record of transfer of data and a copy of the dataset that was distributed will be kept by University of Minnesota.
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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.
Dorothy K Hatsukami, Ph.D principal investigator
University of Minnesota
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ventilated cigarettes only, Unventilated cigarettes only and Access to Experimental Marketplace: Ventilated cigarettes + alternative nicotine delivery systems in people with Smoking and Tobacco Use, run by Masonic Cancer Center, University of Minnesota at 2 sites 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 2 inclusion and 3 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 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 total NNAL at Week 8 Visit (time frame: Week 8). 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 29 Apr 2022.