Tobacco SmokingNCT05259566
Potential Impact of Menthol Ban in Cigarettes and E-cigarettes
A study testing menthol ban in cigarettes only and total menthol ban in people with Tobacco Smoking, run by Yale University at 1 site in United States.
Trial summary
Menthol cigarette use remains a major public health problem and the FDA has proposed to ban menthol in cigarettes. However, additional evidence is needed to understand whether menthol flavor in e-cigarettes is important for harm reduction among menthol cigarette smokers in the context of a menthol cigarette ban. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Tobacco Smoking
- What is being tested?
- menthol ban in cigarettes only and total menthol ban
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2022to 31 Mar 2026
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Age 21 or older
- Able to read English
- Currently smoking cigarettes
- Willing to try e-cigarettes
- In good general health
Who cannot join
- Seeking smoking cessation treatment
- Serious psychiatric or medical condition
- Use of other drugs
- Unable or unwilling to complete study protocol
- Contraindications for study procedures based on medical history
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Potential Impact of a Menthol Ban in Cigarettes and E-cigarettes Among Current Menthol Smokers
Menthol cigarette use remains a major public health problem and the FDA has proposed to ban menthol in cigarettes. However, additional evidence is needed to understand whether menthol flavor in e-cigarettes is important for harm reduction among menthol cigarette smokers in the context of a menthol cigarette ban. The primary aim of this project is to understand how the availability of menthol vs tobacco flavor e-cigarettes influences switching and reduces smoking behavior among adults who currently smoke menthol cigarettes to understand the potential effects in the context of a ban of menthol cigarettes.
Read the detailed description
Menthol cigarette use remains a major public health problem and the FDA has proposed to ban menthol in cigarettes. However, additional evidence is needed to understand whether menthol flavor in e-cigarettes is important for harm reduction among menthol cigarette smokers in the context of a menthol cigarette ban.
The primary aim of this project is to understand how the availability of menthol vs tobacco flavor e-cigarettes influences switching and reduces smoking behavior among adults who currently smoke menthol cigarettes to understand the potential effects in the context of a ban of menthol cigarettes. The secondary aim of this project is to understand whether smoking behavior outcomes differ by race to understand the impact of these potential menthol ban policies on addressing tobacco-related health disparities.
This single site study will take place over a 4 year study period; approximately 14 weeks for each participant's completion.
150 adults who currently smoke menthol cigarettes will be enrolled and prospectively randomized using a randomization ratio of 1:1:1 to 1 of 3 groups (N=50 per group). Following an initial baseline period where participants have access to their usual menthol cigarettes (Phase I), participants will receive tobacco products to use for 8 weeks based on their assigned group modeling 3 possible regulatory scenarios (Phase II): 1) no menthol ban (menthol cigarettes and e-cigarettes available), 2) menthol ban in cigarettes only (non-menthol cigarettes and menthol e-cigarettes available), 3) menthol ban in both cigarettes and e-cigarettes (non-menthol cigarettes and tobacco e-cigarettes available). A follow-up survey at week 12 will assess tobacco use outcomes.
- Conditions
- Tobacco Smoking
- Being tested
- menthol ban in cigarettes only, total menthol ban
- Keywords
- menthol, E-cigarette, cigarette
- Medical subject headings
- Tobacco Smoking, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
menthol ban in cigarettes onlyBehavioural
menthol ban in cigarettes only, menthol available in e-cigarette
total menthol banBehavioural
menthol ban in both cigarettes and e-cigarettes
| Study group | Role | What they receive |
|---|---|---|
| no menthol ban | No intervention | usual menthol cigarettes and menthol flavored e-cigarette available |
| menthol ban in cigarettes only | Experimental | non-menthol cigarettes and menthol flavored e-cigarette available Receives: Behavioral: menthol ban in cigarettes only |
| menthol ban in both cigarettes and e-cigarettes | Experimental | non-menthol cigarettes and tobacco flavored e-cigarette available, Receives: Behavioral: total menthol ban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average number of cigarettes smoked per day in the past week to evaluate changes in smoking behavior
Participants will report the total number of cigarettes consumed each day using the well-validated timeline follow-back (TLFB) interview methods to assess change.
Measured: From Week 0 to week 8
Secondary outcomes (3)
Percent days smoke-free
Participants will report the number of smoke free days over the 8 week study period. Percent days smoke-free will be determined using the TLFB interview methods.
Measured: From Week 0 to week 8
Changes in nicotine dependence using the Nicotine Dependence for Daily Smokers Scale
Changes in nicotine dependence will be measured using the Nicotine Dependence for Daily Smokers Scale from the NIH Patient Reported Outcome Measure Information System (PROMIS) bank. Scores are averaged across 4 items, min=1, max=5. Higher scores indicate greater nicotine dependence.
Measured: From Week 0 to week 8
Change in Quitting motivation and confidence
Quitting motivation and confidence will be assessed using the PhenX Toolkit using the items "How motivated are you to quit smoking?" and "How confident are you that you could quit smoking if you tried?" rated from 1 (not at all) to 10 (extremely).
Measured: Week 0 and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start1 Dec 2022
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco SmokingStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Krysten Bold, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259566
- Sponsor's protocol ID
- 2000032211
- Other IDs
- 1R01DA054993-01A1
- Status last verified
- Jun 2026
- First submitted
- 17 Feb 2022
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the study data is collected and cleaned, and the primary paper is published, de-identified study data will be available for research purposes to qualified individuals within the scientific community by request from the PI or through the National Addiction \& HIV Data Archive Program (NAHDAP) an NIH-funded repository, consistent with NIH guidelines for the timely release and sharing of resources. Additional data documentation and codebooks defining relevant variables, terminology, and scoring guidelines for scale scores will be deposited and made available for sharing along with de-identified data.
Publications
Bold KW, Sharma A, Haeny A, Gueorguieva R, Buta E, Baldassarri S, Lempert L, Krishnan-Sarin S, O'Malley S. A randomized controlled trial of potential tobacco policies prohibiting menthol flavor in cigarettes and e-cigarettes: a study protocol. BMC Psychiatry. 2024 Mar 12;24(1):201. doi: 10.1186/s12888-024-05619-0.
PubMed 38475757
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Potential Impact of a Menthol Ban in Cigarettes and E-cigarettes Among Current Menthol Smokers
- ClinicalTrials.gov ID
- NCT05259566
- Acronym / sponsor ID
- 2000032211
- Conditions
- Tobacco Smoking
- Keywords
- menthol, E-cigarette, cigarette
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 28 Feb 2022 (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.
Menthol cigarette use remains a major public health problem and the FDA has proposed to ban menthol in cigarettes. However, additional evidence is needed to understand whether menthol flavor in e-cigarettes is important for harm reduction among menthol cigarette smokers in the context of a menthol cigarette ban. The primary aim of this project is to understand how the availability of menthol vs tobacco flavor e-cigarettes influences switching and reduces smoking behavior among adults who currently smoke menthol cigarettes to understand the potential effects in the context of a ban of menthol cigarettes.
Detailed description
Menthol cigarette use remains a major public health problem and the FDA has proposed to ban menthol in cigarettes. However, additional evidence is needed to understand whether menthol flavor in e-cigarettes is important for harm reduction among menthol cigarette smokers in the context of a menthol cigarette ban.
The primary aim of this project is to understand how the availability of menthol vs tobacco flavor e-cigarettes influences switching and reduces smoking behavior among adults who currently smoke menthol cigarettes to understand the potential effects in the context of a ban of menthol cigarettes. The secondary aim of this project is to understand whether smoking behavior outcomes differ by race to understand the impact of these potential menthol ban policies on addressing tobacco-related health disparities.
This single site study will take place over a 4 year study period; approximately 14 weeks for each participant's completion.
150 adults who currently smoke menthol cigarettes will be enrolled and prospectively randomized using a randomization ratio of 1:1:1 to 1 of 3 groups (N=50 per group). Following an initial baseline period where participants have access to their usual menthol cigarettes (Phase I), participants will receive tobacco products to use for 8 weeks based on their assigned group modeling 3 possible regulatory scenarios (Phase II): 1) no menthol ban (menthol cigarettes and e-cigarettes available), 2) menthol ban in cigarettes only (non-menthol cigarettes and menthol e-cigarettes available), 3) menthol ban in both cigarettes and e-cigarettes (non-menthol cigarettes and tobacco e-cigarettes available). A follow-up survey at week 12 will assess tobacco use outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| no menthol ban | No intervention | –usual menthol cigarettes and menthol flavored e-cigarette available |
| menthol ban in cigarettes only | Experimental | Behavioral: menthol ban in cigarettes onlynon-menthol cigarettes and menthol flavored e-cigarette available |
| menthol ban in both cigarettes and e-cigarettes | Experimental | Behavioral: total menthol bannon-menthol cigarettes and tobacco flavored e-cigarette available, |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provision of signed and dated informed consent form
- Age 21 or older
- Able to read English
- Currently smoking cigarettes
- Willing to try e-cigarettes
Key exclusion criteria (5 listed)
- Seeking smoking cessation treatment
- Serious psychiatric or medical condition
- Use of other drugs
- Unable or unwilling to complete study protocol
- Contraindications for study procedures based on medical history
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 |
|---|---|---|
| menthol ban in cigarettes onlymenthol ban in cigarettes only, menthol available in e-cigarette | Behavioural | menthol ban in cigarettes only |
| total menthol banmenthol ban in both cigarettes and e-cigarettes | Behavioural | menthol ban in both cigarettes and e-cigarettes |
Primary outcome
Average number of cigarettes smoked per day in the past week to evaluate changes in smoking behavior
Time frame: From Week 0 to week 8
Participants will report the total number of cigarettes consumed each day using the well-validated timeline follow-back (TLFB) interview methods to assess change.
3 secondary outcomes
Percent days smoke-free
Time frame: From Week 0 to week 8
Changes in nicotine dependence using the Nicotine Dependence for Daily Smokers Scale
Time frame: From Week 0 to week 8
Change in Quitting motivation and confidence
Time frame: Week 0 and 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 22 Jun 2026.
- Derived from this study: PubMed 38475757Bold KW, Sharma A, Haeny A, Gueorguieva R, Buta E, Baldassarri S, Lempert L, Krishnan-Sarin S, O'Malley S. A randomized controlled trial of potential tobacco policies prohibiting menthol flavor in cigarettes and e-cigarettes: a study protocol. BMC Psychiatry. 2024 Mar 12;24(1):201. doi: 10.1186/s12888-024-05619-0.
- Individual participant dataSharing planned: Yes. After the study data is collected and cleaned, and the primary paper is published, de-identified study data will be available for research purposes to qualified individuals within the scientific community by request from the PI or through the National Addiction \& HIV Data Archive Program (NAHDAP) an NIH-funded repository, consistent with NIH guidelines for the timely release and sharing of resources. Additional data documentation and codebooks defining relevant variables, terminology, and scoring guidelines for scale scores will be deposited and made available for sharing along with de-identified data.
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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.
Krysten Bold, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing menthol ban in cigarettes only and total menthol ban in people with Tobacco Smoking, run by Yale University 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 6 inclusion and 5 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 22 Jun 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?
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?
Average number of cigarettes smoked per day in the past week to evaluate changes in smoking behavior (time frame: From Week 0 to week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05259566, which also lists 1 linked publication.
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 22 Jun 2026.