Smoking CessationNCT02020005
Evaluation of Cessation Preferences of Menthol Smoker
A study testing Non-flavored 2mg nicotine gum, Non-flavored 4mg nicotine gum and Mint-flavored 2mg nicotine gum in people with Smoking Cessation, run by University of Minnesota at 1 site in United States.
Trial summary
The primary aim of this study is to determine menthol smokers' perception, product preference, and pattern of use across six products including, mint-flavored nicotine gum; non-flavored nicotine gum; mentholated nicotine inhaler; and non-menthol nicotine inhaler. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Non-flavored 2mg nicotine gum, Non-flavored 4mg nicotine gum and Mint-flavored 2mg nicotine gum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Dec 2013
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-identified as African American or Black;
- Aged 18 years or older;
- High school graduate or GED;
- Smoking at least 10 cigarettes daily for the past year;
- Usually smoked mentholated cigarette brand (greater than 80% of the time) in the past two years;
- Good physical health (no unstable medical condition);
- No contraindications for nicotine inhaler or gum use, such as mouth sores or significant dental or jaw problems;
- Stable, good health.
Who cannot join
- Recent unstable or untreated psychiatric diagnosis including substance abuse, as determined by the DSM-IV criteria;
- Currently using other tobacco or nicotine products other than cigarettes;
- Pregnant or nursing.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, 55455
About this study
Official title: Evaluation of Cessation Preferences of Menthol Smokers
The primary aim of this study is to determine menthol smokers' perception, product preference, and pattern of use across six products including, mint-flavored nicotine gum; non-flavored nicotine gum; mentholated nicotine inhaler; and non-menthol nicotine inhaler. Participants will undergo an orientation and baseline assessment followed by a 2-week product sampling phase. At the end of the 2 weeks of sampling, subjects will select a product to use during the following 2-week smoking cessation phase. This 2-week abstinence phase is followed by one week of abrupt withdrawal of the product. This study design was successfully used in a study we conducted that examined the smokers' preference for a variety or oral tobacco products.
- Conditions
- Smoking Cessation
- Being tested
- Non-flavored 2mg nicotine gum, Non-flavored 4mg nicotine gum, Mint-flavored 2mg nicotine gum, Mint-flavored 4mg nicotine gum, Non-flavored nicotine inhaler
- Keywords
- menthol cigarettes, smoking cessation
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-flavored 2mg nicotine gumOther
Non-flavored 4mg nicotine gumOther
Mint-flavored 2mg nicotine gumOther
Mint-flavored 4mg nicotine gumOther
Non-flavored nicotine inhalerOther
Mint-flavored nicotine ihalerOther
| Study group | Role | What they receive |
|---|---|---|
| non-flavored 2mg nicotine gum | Experimental | All subjects will test six different nicotine replacement products over the course of the 2-week product sampling phase. The six nicotine replacement products being tested are non-flavored 2mg nicotine gum, non-flavored 4mg nicotine gum, mint-flavored 2mg nicotine gum, mint-flavored 4mg nicotine gum, non-flavored nicotine inhaler and mint-flavored inhaler. The order in which the subjects test these products will be randomized and subjects will be blinded to the nicotine content of the product but will be instructed about the flavor of the product. Receives: Other: Non-flavored 2mg nicotine gum |
| non-flavored 4mg nicotine gum | Experimental | All subjects will test six different nicotine replacement products over the course of the 2-week product sampling phase. The six nicotine replacement products being tested are non-flavored 2mg nicotine gum, non-flavored 4mg nicotine gum, mint-flavored 2mg nicotine gum, mint-flavored 4mg nicotine gum, non-flavored nicotine inhaler and mint-flavored inhaler. The order in which the subjects test these products will be randomized and subjects will be blinded to the nicotine content of the product but will be instructed about the flavor of the product. Receives: Other: Non-flavored 4mg nicotine gum |
| mint-flavored 2mg nicotine gum | Experimental | All subjects will test six different nicotine replacement products over the course of the 2-week product sampling phase. The six nicotine replacement products being tested are non-flavored 2mg nicotine gum, non-flavored 4mg nicotine gum, mint-flavored 2mg nicotine gum, mint-flavored 4mg nicotine gum, non-flavored nicotine inhaler and mint-flavored inhaler. The order in which the subjects test these products will be randomized and subjects will be blinded to the nicotine content of the product but will be instructed about the flavor of the product. Receives: Other: Mint-flavored 2mg nicotine gum |
| mint-flavored 4mg nicotine gum | Experimental | All subjects will test six different nicotine replacement products over the course of the 2-week product sampling phase. The six nicotine replacement products being tested are non-flavored 2mg nicotine gum, non-flavored 4mg nicotine gum, mint-flavored 2mg nicotine gum, mint-flavored 4mg nicotine gum, non-flavored nicotine inhaler and mint-flavored inhaler. The order in which the subjects test these products will be randomized and subjects will be blinded to the nicotine content of the product but will be instructed about the flavor of the product. Receives: Other: Mint-flavored 4mg nicotine gum |
| non-flavored nicotine inhaler | Experimental | All subjects will test six different nicotine replacement products over the course of the 2-week product sampling phase. The six nicotine replacement products being tested are non-flavored 2mg nicotine gum, non-flavored 4mg nicotine gum, mint-flavored 2mg nicotine gum, mint-flavored 4mg nicotine gum, non-flavored nicotine inhaler and mint-flavored inhaler. The order in which the subjects test these products will be randomized and subjects will be blinded to the nicotine content of the product but will be instructed about the flavor of the product. Receives: Other: Non-flavored nicotine inhaler |
| mint-flavored inhaler | Experimental | All subjects will test six different nicotine replacement products over the course of the 2-week product sampling phase. The six nicotine replacement products being tested are non-flavored 2mg nicotine gum, non-flavored 4mg nicotine gum, mint-flavored 2mg nicotine gum, mint-flavored 4mg nicotine gum, non-flavored nicotine inhaler and mint-flavored inhaler. The order in which the subjects test these products will be randomized and subjects will be blinded to the nicotine content of the product but will be instructed about the flavor of the product. Receives: Other: Mint-flavored nicotine ihaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Product preference for nicotine replacement
To determine menthol smokers' product perception and preference across 6 different types of products with varying mint content.
Measured: 6 weeks
Secondary outcomes (1)
Nicotine content preference
To determine menthol smokers' product perception and preference across 6 different types of products with varying nicotine content.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kola Okuyemi, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02020005
- Sponsor's protocol ID
- 2013NTLS014
- Status last verified
- Oct 2025
- First submitted
- 18 Dec 2013
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cessation Preferences of Menthol Smokers
- ClinicalTrials.gov ID
- NCT02020005
- Acronym / sponsor ID
- 2013NTLS014
- Conditions
- Smoking Cessation
- Keywords
- menthol cigarettes, smoking cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 24 Dec 2013 (estimated)
- 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.
The primary aim of this study is to determine menthol smokers' perception, product preference, and pattern of use across six products including, mint-flavored nicotine gum; non-flavored nicotine gum; mentholated nicotine inhaler; and non-menthol nicotine inhaler. Participants will undergo an orientation and baseline assessment followed by a 2-week product sampling phase. At the end of the 2 weeks of sampling, subjects will select a product to use during the following 2-week smoking cessation phase. This 2-week abstinence phase is followed by one week of abrupt withdrawal of the product. This study design was successfully used in a study we conducted that examined the smokers' preference for a variety or oral tobacco products.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| non-flavored 2mg nicotine gum | Experimental | Other: Non-flavored 2mg nicotine gumAll subjects will test six different nicotine replacement products over the course of the 2-week product sampling phase. The six nicotine replacement products being tested are non-flavored 2mg nicotine gum, non-flavored 4mg nicotine gum, mint-flavored 2mg nicotine gum, mint-flavored 4mg nicotine gum, non-flavored nicotine inhaler and mint-flavored inhaler. The order in which the subjects test these products will be randomized and subjects will be blinded to the nicotine content of the product but will be instructed about the flavor of the product. |
| non-flavored 4mg nicotine gum | Experimental | Other: Non-flavored 4mg nicotine gumAll subjects will test six different nicotine replacement products over the course of the 2-week product sampling phase. The six nicotine replacement products being tested are non-flavored 2mg nicotine gum, non-flavored 4mg nicotine gum, mint-flavored 2mg nicotine gum, mint-flavored 4mg nicotine gum, non-flavored nicotine inhaler and mint-flavored inhaler. The order in which the subjects test these products will be randomized and subjects will be blinded to the nicotine content of the product but will be instructed about the flavor of the product. |
| mint-flavored 2mg nicotine gum | Experimental | Other: Mint-flavored 2mg nicotine gumAll subjects will test six different nicotine replacement products over the course of the 2-week product sampling phase. The six nicotine replacement products being tested are non-flavored 2mg nicotine gum, non-flavored 4mg nicotine gum, mint-flavored 2mg nicotine gum, mint-flavored 4mg nicotine gum, non-flavored nicotine inhaler and mint-flavored inhaler. The order in which the subjects test these products will be randomized and subjects will be blinded to the nicotine content of the product but will be instructed about the flavor of the product. |
| mint-flavored 4mg nicotine gum | Experimental | Other: Mint-flavored 4mg nicotine gumAll subjects will test six different nicotine replacement products over the course of the 2-week product sampling phase. The six nicotine replacement products being tested are non-flavored 2mg nicotine gum, non-flavored 4mg nicotine gum, mint-flavored 2mg nicotine gum, mint-flavored 4mg nicotine gum, non-flavored nicotine inhaler and mint-flavored inhaler. The order in which the subjects test these products will be randomized and subjects will be blinded to the nicotine content of the product but will be instructed about the flavor of the product. |
| non-flavored nicotine inhaler | Experimental | Other: Non-flavored nicotine inhalerAll subjects will test six different nicotine replacement products over the course of the 2-week product sampling phase. The six nicotine replacement products being tested are non-flavored 2mg nicotine gum, non-flavored 4mg nicotine gum, mint-flavored 2mg nicotine gum, mint-flavored 4mg nicotine gum, non-flavored nicotine inhaler and mint-flavored inhaler. The order in which the subjects test these products will be randomized and subjects will be blinded to the nicotine content of the product but will be instructed about the flavor of the product. |
| mint-flavored inhaler | Experimental | Other: Mint-flavored nicotine ihalerAll subjects will test six different nicotine replacement products over the course of the 2-week product sampling phase. The six nicotine replacement products being tested are non-flavored 2mg nicotine gum, non-flavored 4mg nicotine gum, mint-flavored 2mg nicotine gum, mint-flavored 4mg nicotine gum, non-flavored nicotine inhaler and mint-flavored inhaler. The order in which the subjects test these products will be randomized and subjects will be blinded to the nicotine content of the product but will be instructed about the flavor of the product. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Self-identified as African American or Black;
- Aged 18 years or older;
- High school graduate or GED;
- Smoking at least 10 cigarettes daily for the past year;
- Usually smoked mentholated cigarette brand (greater than 80% of the time) in the past two years;
Key exclusion criteria (3 listed)
- Recent unstable or untreated psychiatric diagnosis including substance abuse, as determined by the DSM-IV criteria;
- Currently using other tobacco or nicotine products other than cigarettes;
- 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 |
|---|---|---|
| Non-flavored 2mg nicotine gum | Other | non-flavored 2mg nicotine gum |
| Non-flavored 4mg nicotine gum | Other | non-flavored 4mg nicotine gum |
| Mint-flavored 2mg nicotine gum | Other | mint-flavored 2mg nicotine gum |
| Mint-flavored 4mg nicotine gum | Other | mint-flavored 4mg nicotine gum |
| Non-flavored nicotine inhaler | Other | non-flavored nicotine inhaler |
| Mint-flavored nicotine ihaler | Other | mint-flavored inhaler |
Primary outcome
Product preference for nicotine replacement
Time frame: 6 weeks
To determine menthol smokers' product perception and preference across 6 different types of products with varying mint content.
1 secondary outcome
Nicotine content preference
Time frame: 6 weeks
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 3 Oct 2025.
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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.
Kola Okuyemi, MD 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?
A study testing Non-flavored 2mg nicotine gum, Non-flavored 4mg nicotine gum and Mint-flavored 2mg nicotine gum in people with Smoking Cessation, 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 8 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 3 Oct 2025. 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?
Product preference for nicotine replacement (time frame: 6 weeks). 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 3 Oct 2025.