Tobacco SmokingCOMETNCT03111537
Methods Project 4: Clinical Trial - Amended
A study testing Cigarettes, E-Cigarette and Nicotine Gum or Lozenge in people with Tobacco Smoking, run by University of Minnesota at 3 sites in United States.
Trial summary
Cigarette smokers will be randomized to E-cigarette, Nicotine Gum or Lozenge, or Control Group. Participants will enter a 1 week sampling phase. Smokers interested in continuing with the study after the sampling phase will undergo a 2 week baseline assessment phase and will then enter an 8 week intervention. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Smoking
- What is being tested?
- Cigarettes, E-Cigarette and Nicotine Gum or Lozenge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2015to Feb 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects who are at least 18 years of age;
- Daily smoker;
- Generally good health;
- Subject has provided written informed consent to participate in the study (adolescents under the age of 18 will be excluded because this project involves continued use of tobacco products and new tobacco products);
Who cannot join
- Unstable health;
- Pregnant or breastfeeding (due to toxic effects from tobacco products);
- Unable to read for comprehension or completion of study documents.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Roswell Park Cancer Center
Buffalo, New York, 14263
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Project 4: Clinical Trial Method for Assessing a Tobacco Product Part of Models for Tobacco Product Evaluation:
Cigarette smokers will be randomized to E-cigarette, Nicotine Gum or Lozenge, or Control Group. Participants will enter a 1 week sampling phase. Smokers interested in continuing with the study after the sampling phase will undergo a 2 week baseline assessment phase and will then enter an 8 week intervention. Tobacco use patterns, subjective responses to product, and nicotine and toxicant exposure will be assessed.
Read the detailed description
Sampling period (1 week): Subjects will be randomized to an alternative nicotine product (E-cigarette, Nicotine Gum or Lozenge) or assigned to continue smoking their usual brand cigarettes. Subjects will complete screening assessments, asked to sample the assigned product and start recording their cigarette or other tobacco intake on a daily basis using an interactive voice response system (IVR). Smokers assigned to the control condition (smoking usual brand cigarettes) will be asked to choose the product that they would like to sample.
Baseline smoking period: After sampling, subjects who meet specific criteria will continue with the experimental intervention phase. These subjects will be required to attend 2 baseline clinic visits where baseline assessments will be captured. Records of their cigarette or other tobacco intake on a daily basis will continue using the interactive voice response system (IVR).
Experimental Period: After the baseline assessment, subjects will be instructed to either partially or completely substitute their cigarette smoking with their assigned product. They will assigned to one of six experimental conditions:
- smoking usual brand cigarette controls, who after 8-weeks will be offered any of the other nicotine products to use as they choose for 8 weeks;
- complete substitution (i.e., no smoking) with an E-cigarette;
- partial substitution with an E-cigarette;
- complete substitution (i.e., no smoking) with nicotine gum or nicotine lozenge.
The assigned product, E-cigarette, Nic Gum or Lozenge, but not usual brand cigarettes, will be provided to subjects at the clinic visits. Subjects will attend clinic visits over the next 8 weeks where tobacco use patterns and biomarker data will be collected.
- Conditions
- Tobacco Smoking
- Being tested
- Cigarettes, E-Cigarette, Nicotine Gum or Lozenge
- Keywords
- cigarette, smoking, e-cigarette, nicotine replacement therapy, nrt, tobacco
- Medical subject headings
- Tobacco Smoking, Smoking, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CigarettesOther
Smoke their usual brand of cigarettes and follow their normal patterns of use.
E-CigaretteOther
Use of E-cigarette: multiple flavors offered.
Nicotine Gum or LozengeOther
Subject choice: Use of nicotine gum or nicotine lozenge, multiple flavors offered
| Study group | Role | What they receive |
|---|---|---|
| Usual Brand Cigarette | Experimental | Smoking usual brand cigarette controls, who after 8-weeks will be offered alternative nicotine products and instructed for partial or complete substitution of cigarettes (subject's choice); Receives: Other: Cigarettes |
| Complete Substitution E-Cigarette | Experimental | Complete substitution (i.e., no smoking) with e-cigarette use Receives: Other: E-Cigarette |
| Partial Substitution E-Cigarette | Experimental | Partial substitution, encouraged to use e-cigarettes instead of smoking usual cigarettes Receives: Other: Cigarettes; Other: E-Cigarette |
| Complete Substitution Nic Gum or Lozenge | Experimental | Complete substitution (i.e., no smoking) to nicotine gum or lozenge use Receives: Other: Nicotine Gum or Lozenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare total nicotine equivalents (TNE) based on differing instructions for oral tobacco, nicotine replacement or e-cigarette use.
Compare the exposure to nicotine in the two instructions for use arms (complete substitution vs. partial substitution) across study products and compared to medicinal nicotine products and usual brand cigarettes.
Measured: 6 months
Determine stabilization of product use (e.g., cigarette, oral tobacco, e-cigarette or medicinal nicotine patterns of use).
Examining time effects for patterns of use of cigarettes, nicotine replacement, oral tobacco or e-cigarette.
Measured: 6 months
Consumer perception of the product and response to the product after sampling.
Consumer perception of the product evidenced by choice of which product to use in the trial after sampling.
Measured: 6 months
Compare NNK exposure based on differing instructions for oral tobacco, nicotine replacement or e-cigarette use.
Complete substitution vs. partial substitution of study products for cigarettes and compare the exposure to NNK by analyzing NNAL levels in subject urine. These products are compared to medicinal nicotine products and usual brand cigarettes.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study startMay 2015
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111537
- Sponsor's protocol ID
- 2012NTLS050b
- Acronym
- COMET
- Status last verified
- Sep 2022
- First submitted
- 21 May 2015
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project 4: Clinical Trial Method for Assessing a Tobacco Product Part of Models for Tobacco Product Evaluation:
- ClinicalTrials.gov ID
- NCT03111537
- Acronym / sponsor ID
- COMET / 2012NTLS050b
- Conditions
- Tobacco Smoking
- Keywords
- cigarette, smoking, e-cigarette, nicotine replacement therapy, nrt, tobacco
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 13 Apr 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.
Cigarette smokers will be randomized to E-cigarette, Nicotine Gum or Lozenge, or Control Group. Participants will enter a 1 week sampling phase. Smokers interested in continuing with the study after the sampling phase will undergo a 2 week baseline assessment phase and will then enter an 8 week intervention. Tobacco use patterns, subjective responses to product, and nicotine and toxicant exposure will be assessed.
Detailed description
Sampling period (1 week): Subjects will be randomized to an alternative nicotine product (E-cigarette, Nicotine Gum or Lozenge) or assigned to continue smoking their usual brand cigarettes. Subjects will complete screening assessments, asked to sample the assigned product and start recording their cigarette or other tobacco intake on a daily basis using an interactive voice response system (IVR). Smokers assigned to the control condition (smoking usual brand cigarettes) will be asked to choose the product that they would like to sample.
Baseline smoking period: After sampling, subjects who meet specific criteria will continue with the experimental intervention phase. These subjects will be required to attend 2 baseline clinic visits where baseline assessments will be captured. Records of their cigarette or other tobacco intake on a daily basis will continue using the interactive voice response system (IVR).
Experimental Period: After the baseline assessment, subjects will be instructed to either partially or completely substitute their cigarette smoking with their assigned product. They will assigned to one of six experimental conditions:
- smoking usual brand cigarette controls, who after 8-weeks will be offered any of the other nicotine products to use as they choose for 8 weeks;
- complete substitution (i.e., no smoking) with an E-cigarette;
- partial substitution with an E-cigarette;
- complete substitution (i.e., no smoking) with nicotine gum or nicotine lozenge.
The assigned product, E-cigarette, Nic Gum or Lozenge, but not usual brand cigarettes, will be provided to subjects at the clinic visits. Subjects will attend clinic visits over the next 8 weeks where tobacco use patterns and biomarker data will be collected.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Usual Brand Cigarette | Experimental | Other: CigarettesSmoking usual brand cigarette controls, who after 8-weeks will be offered alternative nicotine products and instructed for partial or complete substitution of cigarettes (subject's choice); |
| Complete Substitution E-Cigarette | Experimental | Other: E-CigaretteComplete substitution (i.e., no smoking) with e-cigarette use |
| Partial Substitution E-Cigarette | Experimental | Other: Cigarettes, Other: E-CigarettePartial substitution, encouraged to use e-cigarettes instead of smoking usual cigarettes |
| Complete Substitution Nic Gum or Lozenge | Experimental | Other: Nicotine Gum or LozengeComplete substitution (i.e., no smoking) to nicotine gum or lozenge use |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subjects who are at least 18 years of age;
- Daily smoker;
- Generally good health;
- Subject has provided written informed consent to participate in the study (adolescents under the age of 18 will be excluded because this project involves continued use of tobacco products and new tobacco products);
Key exclusion criteria (3 listed)
- Unstable health;
- Pregnant or breastfeeding (due to toxic effects from tobacco products);
- Unable to read for comprehension or completion of study documents.
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 |
|---|---|---|
| CigarettesSmoke their usual brand of cigarettes and follow their normal patterns of use. | Other | Partial Substitution E-Cigarette, Usual Brand Cigarette |
| E-CigaretteUse of E-cigarette: multiple flavors offered. | Other | Complete Substitution E-Cigarette, Partial Substitution E-Cigarette |
| Nicotine Gum or LozengeSubject choice: Use of nicotine gum or nicotine lozenge, multiple flavors offered | Other | Complete Substitution Nic Gum or Lozenge |
Primary outcome
Compare total nicotine equivalents (TNE) based on differing instructions for oral tobacco, nicotine replacement or e-cigarette use.
Time frame: 6 months
Compare the exposure to nicotine in the two instructions for use arms (complete substitution vs. partial substitution) across study products and compared to medicinal nicotine products and usual brand cigarettes.
Determine stabilization of product use (e.g., cigarette, oral tobacco, e-cigarette or medicinal nicotine patterns of use).
Time frame: 6 months
Examining time effects for patterns of use of cigarettes, nicotine replacement, oral tobacco or e-cigarette.
Consumer perception of the product and response to the product after sampling.
Time frame: 6 months
Consumer perception of the product evidenced by choice of which product to use in the trial after sampling.
Compare NNK exposure based on differing instructions for oral tobacco, nicotine replacement or e-cigarette use.
Time frame: 8 weeks
Complete substitution vs. partial substitution of study products for cigarettes and compare the exposure to NNK by analyzing NNAL levels in subject urine. These products are compared to medicinal nicotine products and usual brand cigarettes.
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 28 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cigarettes, E-Cigarette and Nicotine Gum or Lozenge in people with Tobacco Smoking, run by University of Minnesota at 3 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 4 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 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
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?
Compare total nicotine equivalents (TNE) based on differing instructions for oral tobacco, nicotine replacement or e-cigarette use. (time frame: 6 months). The study lists 4 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 28 Sep 2022; AzTrials last refreshed its copy on 28 Oct 2026.