Smoking Prevention and ControlNCT05896033
Impact of Cigarette and E-cigarette Menthol Regulation on Current Smokers of Menthol Cigarettes
A study testing Non-Menthol Cigarettes, Tobacco Flavored E-cigarettes and Menthol Cigarettes in people with Smoking Prevention and Control, run by Medical University of South Carolina at 1 site in United States.
Trial summary
In a 2x2 design, current menthol smokers (N=240) will complete a baseline period before being assigned to a cigarette (menthol or non-menthol) and e-cigarette condition (menthol or tobacco-flavored e-liquid) and receiving a 7-week supply of cigarettes and e-cigarettes. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Prevention and Control
- What is being tested?
- Non-Menthol Cigarettes, Tobacco Flavored E-cigarettes and Menthol Cigarettes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2023to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adults (21+) who a) have been smoking at least 5 cigarettes daily for one year
- usual brand (the brand used most often) is mentholated
- have a smartphone that can receive text messages and access the internet (necessary for diary completion).
Who cannot join
- other tobacco and pharmacotherapy criteria
- health and safety criteria
- planning to move out of the area within the next 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Tracy Smith, PhD, 843-792-5164, smithtra@musc.edu
About this study
Official title: The Impact of Menthol Regulation for Cigarettes and E-cigarettes on Tobacco Use Patterns for Current Menthol Smokers
In a 2x2 design, current menthol smokers (N=240) will complete a baseline period before being assigned to a cigarette (menthol or non-menthol) and e-cigarette condition (menthol or tobacco-flavored e-liquid) and receiving a 7-week supply of cigarettes and e-cigarettes. The study builds upon our well-established methodology for simulating tobacco regulatory policies. To model a ban, smokers will be instructed to only use their assigned products. Primary outcomes include cigarette smoking and e-cigarette use during Week 6. However, because a menthol ban may impact the ability to abstain from smoking, the investigators will incentivize participants to abstain from smoking during Week 7 (continued e-cigarette use allowed) and assess the time to first lapse. Participants will complete daily electronic diaries assessing tobacco product use throughout, which will be corroborated by biomarkers for menthol, nicotine, and smoke. Finally, to maximize the utility of these data for FDA regulation, the investigators will assess whether any demographic or baseline smoking characteristics moderate the observed treatment effects, calibrate the treatment effects to the US adult menthol smoking population, and model the effects of menthol regulation in cigarettes and e-cigarettes on smoking and vaping-attributable deaths and life-years lost.
- Conditions
- Smoking Prevention and Control
- Being tested
- Non-Menthol Cigarettes, Tobacco Flavored E-cigarettes, Menthol Cigarettes, Menthol Flavored E-cigarettes
- Keywords
- Smoking, Menthol
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Menthol CigarettesBehavioural
Ppts will be randomly assigned to a group that receives non-menthol cigarettes
Tobacco Flavored E-cigarettesBehavioural
Ppts will be randomly assigned to a group that receives tobacco flavored e-cigarettes
Menthol CigarettesBehavioural
Ppts will be randomly assigned to a group that receives menthol flavored cigarettes
Menthol Flavored E-cigarettesBehavioural
Ppts will be randomly assigned to a group that receives menthol flavored e-cigarettes
| Study group | Role | What they receive |
|---|---|---|
| Menthol Spectrum Cigarettes and Menthol E-cigarettes | Experimental | Ppts will be randomly assigned to receive the menthol spectrum cigarettes and Njoy Ace menthol e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit. Receives: Behavioral: Menthol Cigarettes; Behavioral: Menthol Flavored E-cigarettes |
| Menthol Spectrum Cigarettes and Tobacco E-cigarettes | Experimental | Ppts will be randomly assigned to receive the menthol spectrum cigarettes and Njoy Ace tobacco e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit. Receives: Behavioral: Tobacco Flavored E-cigarettes; Behavioral: Menthol Cigarettes |
| Non-menthol Spectrum Cigarettes and Menthol E-cigarettes | Experimental | Ppts will be randomly assigned to receive the non-menthol spectrum cigarettes and Njoy Ace menthol e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit. Receives: Behavioral: Non-Menthol Cigarettes; Behavioral: Menthol Flavored E-cigarettes |
| Non-menthol Spectrum Cigarettes and Tobacco E-cigarettes | Experimental | Ppts will be randomly assigned to receive the non-menthol spectrum cigarettes and Njoy Ace tobacco e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit. Receives: Behavioral: Non-Menthol Cigarettes; Behavioral: Tobacco Flavored E-cigarettes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cigarettes per day
Will be measured through week 6 of the study
Measured: Week 1- Week 6
Secondary outcomes (2)
Fagerstrom Test for Nicotine Dependence
Cigarette Dependence
Measured: Week 1- Week 7
Ability to abstain from smoking
Participants will complete a 1-week practice quit attempt in week 7; time to first smoking lapse will be assessed.
Measured: Week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start23 Oct 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking Prevention and ControlStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), University of Minnesota, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896033
- Sponsor's protocol ID
- 00122898
- Other IDs
- 1R01DA055985-01A1
- Status last verified
- Jul 2026
- First submitted
- 19 May 2023
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Menthol Regulation for Cigarettes and E-cigarettes on Tobacco Use Patterns for Current Menthol Smokers
- ClinicalTrials.gov ID
- NCT05896033
- Acronym / sponsor ID
- 00122898
- Conditions
- Smoking Prevention and Control
- Keywords
- Smoking, Menthol
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), University of Minnesota, National Institute on Drug Abuse (NIDA)
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 9 Jun 2023 (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.
In a 2x2 design, current menthol smokers (N=240) will complete a baseline period before being assigned to a cigarette (menthol or non-menthol) and e-cigarette condition (menthol or tobacco-flavored e-liquid) and receiving a 7-week supply of cigarettes and e-cigarettes. The study builds upon our well-established methodology for simulating tobacco regulatory policies. To model a ban, smokers will be instructed to only use their assigned products. Primary outcomes include cigarette smoking and e-cigarette use during Week 6. However, because a menthol ban may impact the ability to abstain from smoking, the investigators will incentivize participants to abstain from smoking during Week 7 (continued e-cigarette use allowed) and assess the time to first lapse. Participants will complete daily electronic diaries assessing tobacco product use throughout, which will be corroborated by biomarkers for menthol, nicotine, and smoke. Finally, to maximize the utility of these data for FDA regulation, the investigators will assess whether any demographic or baseline smoking characteristics moderate the observed treatment effects, calibrate the treatment effects to the US adult menthol smoking population, and model the effects of menthol regulation in cigarettes and e-cigarettes on smoking and vaping-attributable deaths and life-years lost.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Menthol Spectrum Cigarettes and Menthol E-cigarettes | Experimental | Behavioral: Menthol Cigarettes, Behavioral: Menthol Flavored E-cigarettesPpts will be randomly assigned to receive the menthol spectrum cigarettes and Njoy Ace menthol e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit. |
| Menthol Spectrum Cigarettes and Tobacco E-cigarettes | Experimental | Behavioral: Tobacco Flavored E-cigarettes, Behavioral: Menthol CigarettesPpts will be randomly assigned to receive the menthol spectrum cigarettes and Njoy Ace tobacco e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit. |
| Non-menthol Spectrum Cigarettes and Menthol E-cigarettes | Experimental | Behavioral: Non-Menthol Cigarettes, Behavioral: Menthol Flavored E-cigarettesPpts will be randomly assigned to receive the non-menthol spectrum cigarettes and Njoy Ace menthol e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit. |
| Non-menthol Spectrum Cigarettes and Tobacco E-cigarettes | Experimental | Behavioral: Non-Menthol Cigarettes, Behavioral: Tobacco Flavored E-cigarettesPpts will be randomly assigned to receive the non-menthol spectrum cigarettes and Njoy Ace tobacco e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adults (21+) who a) have been smoking at least 5 cigarettes daily for one year
- usual brand (the brand used most often) is mentholated
- have a smartphone that can receive text messages and access the internet (necessary for diary completion).
Key exclusion criteria (3 listed)
- other tobacco and pharmacotherapy criteria
- health and safety criteria
- planning to move out of the area within the next 3 months
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-Menthol CigarettesPpts will be randomly assigned to a group that receives non-menthol cigarettes | Behavioural | Non-menthol Spectrum Cigarettes and Menthol E-cigarettes, Non-menthol Spectrum Cigarettes and Tobacco E-cigarettes |
| Tobacco Flavored E-cigarettesPpts will be randomly assigned to a group that receives tobacco flavored e-cigarettes | Behavioural | Menthol Spectrum Cigarettes and Tobacco E-cigarettes, Non-menthol Spectrum Cigarettes and Tobacco E-cigarettes |
| Menthol CigarettesPpts will be randomly assigned to a group that receives menthol flavored cigarettes | Behavioural | Menthol Spectrum Cigarettes and Menthol E-cigarettes, Menthol Spectrum Cigarettes and Tobacco E-cigarettes |
| Menthol Flavored E-cigarettesPpts will be randomly assigned to a group that receives menthol flavored e-cigarettes | Behavioural | Menthol Spectrum Cigarettes and Menthol E-cigarettes, Non-menthol Spectrum Cigarettes and Menthol E-cigarettes |
Primary outcome
Changes in cigarettes per day
Time frame: Week 1- Week 6
Will be measured through week 6 of the study
2 secondary outcomes
Fagerstrom Test for Nicotine Dependence
Time frame: Week 1- Week 7
Ability to abstain from smoking
Time frame: Week 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
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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.
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-Menthol Cigarettes, Tobacco Flavored E-cigarettes and Menthol Cigarettes in people with Smoking Prevention and Control, run by Medical University of South Carolina 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 3 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: looking for participants now, as of the sponsor's last update on 21 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tracy T Smith (8437925164, smithtra@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in cigarettes per day (time frame: Week 1- Week 6). 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 21 Jul 2026.