Tobacco DependenceNCT06477601
Cooling Agent Pilot Among Adult Menthol Smokers
A study testing Assigning cooling agent type cigarettes, Assigning traditional tobacco type cigarettes and Assigning menthol type cigarettes in people with Tobacco Dependence, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
Recent studies and market monitoring have shown that in places where menthol cigarettes are no longer available, tobacco companies have started marketing "non-menthol cooling cigarettes". Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Dependence
- What is being tested?
- Assigning cooling agent type cigarettes, Assigning traditional tobacco type cigarettes and Assigning menthol type cigarettes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2024to 1 Oct 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Current cigarette smoker
- Smoke at least 5 cigarettes per day
- Smoke on at least 25 of the past 30 days
- Smoke menthol cigarettes for at least 1 year
- At least 21 years old
- Willing to try a product switch for 3 weeks and be followed for 6 weeks
Show all 14Show fewer
- Willing to not use marijuana in place of the study product
- Willing to refrain from other tobacco product use for 3 weeks during the study
- Speak and understand English
- Willing to provide informed consent
- Own cell or landline phone
- Have reliable transportation
- Plan to remain in the Kansas City area for the full duration of the study (6 weeks)
- Bring pack of menthol cigarettes to W0 study visit
Who cannot join
- E-cigarette use on greater than 4 of the past 30 days
- Other tobacco product use on greater than 4 of the past 30 days
- Interested in quitting smoking (i.e., setting a quit date) in the next 30 day
- Current use of cessation medications
- Household member currently or previously enrolled in the study
- Currently pregnant
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Tobacco Treatment Center
Kansas City, Missouri, 64130
About this study
Official title: Impact of WS-3, Menthol, and Non-menthol Cigarettes on Cigarette Smoking and Abuse Liability Among Adult Menthol Smokers: A Pilot Investigation
Recent studies and market monitoring have shown that in places where menthol cigarettes are no longer available, tobacco companies have started marketing "non-menthol cooling cigarettes". Little is known about what current menthol smokers think of these non-menthol cooling cigarettes and how they compare to regular menthol cigarettes. By doing this study, the investigators hope to learn what menthol smokers think of these cigarettes and how they impact how menthol smokers smoke.
Read the detailed description
The Food and Drug Administration has been considering a potential federal restriction on menthol as a characterizing flavor in combustible cigarettes, a policy that would likely significantly reduce tobacco related disparities among Black adults who smoke menthol cigarette. However, in states where this policy has been enacted and menthol cigarettes are off the market, the tobacco industry has circumvented the restriction by introducing new non-menthol cigarettes that include WS-3, a chemical that acts as a cooling agent but without use of menthol. Our team is interested in understanding the extent to which WS-3 undermines a potential future menthol ban and the impact on the reduction in cigarettes smoked, particularly among Black adults who smoke.
The overall objective of this application is to obtain effect sizes and establish feasibility for an upcoming R01 submission. Specific aims include: Aim1: Determine the change in total cigarettes per day (CPD) when using menthol cigarettes, WS-3 cigarettes, and traditional non-menthol cigarettes. The primary comparison is between WS-3 and traditional non-menthol cigarettes. Aim 2: Understand the comparative abuse liability during ad libitum use of menthol cigarettes, WS-3 synthetic cooling agent cigarettes, and traditional non-menthol cigarettes. The study intervention involves providing study participants, who are all adult current smokers with no intention to quit or alter their cigarette smoking, with either menthol cigarettes, WS-3 synthetic cooling agent cigarettes, or traditional non-menthol cigarettes. All study products are commercially available. Participants will report on their usual number of cigarettes per day and will be provided a commensurate amount of study cigarettes to allow them to make a complete switch to the study product for the duration of the 6 week research study.
- Conditions
- Tobacco Dependence
- Being tested
- Assigning cooling agent type cigarettes, Assigning traditional tobacco type cigarettes, Assigning menthol type cigarettes
- Keywords
- tobacco
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assigning cooling agent type cigarettesOther
This study is intended to help understand what people who smoke menthol cigarettes would do in a scenario where the Food and Drug Administration bans menthol cigarettes but allows cooling agent cigarettes.
Assigning traditional tobacco type cigarettesOther
This comparison group is intended to help understand what people who smoke menthol cigarettes would do in a scenario where the Food and Drug Administration bans menthol and cooling agent cigarettes.
Assigning menthol type cigarettesOther
This comparison group is for where the Food and Drug Administration does not ban menthol cigarettes.
| Study group | Role | What they receive |
|---|---|---|
| Continued menthol smoking | Active comparator | Current menthol smokers will be assigned to smoke study provided menthol cigarettes. Receives: Other: Assigning menthol type cigarettes |
| Synthetic cooling agent cigarette smoking | Experimental | Current menthol smokers will be assigned to smoke study provided synthetic cooling agent cigarettes. Receives: Other: Assigning cooling agent type cigarettes |
| Traditional non-menthol cigarette smoking | Experimental | Current menthol smokers will be assigned to smoke study provided traditional non-menthol cigarettes. Receives: Other: Assigning traditional tobacco type cigarettes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cigarette changes from baseline to week 3
4.1 The primary study endpoint is changes in total cigarettes per day from baseline to week 3.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start24 Jun 2024
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco DependenceStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be 20 adult current menthol smokers. Participants will be randomized to continued menthol smoking (n = 4), WS-3 synthetic cooling agent cigarette smoking (n = 8), or traditional non-menthol cigarette smoking (n = 8).
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eleanor Leavens, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06477601
- Sponsor's protocol ID
- 160670
- Status last verified
- Apr 2025
- First submitted
- 21 Jun 2024
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of WS-3, Menthol, and Non-menthol Cigarettes on Cigarette Smoking and Abuse Liability Among Adult Menthol Smokers: A Pilot Investigation
- ClinicalTrials.gov ID
- NCT06477601
- Acronym / sponsor ID
- 160670
- Conditions
- Tobacco Dependence
- Keywords
- tobacco
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 27 Jun 2024 (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.
Recent studies and market monitoring have shown that in places where menthol cigarettes are no longer available, tobacco companies have started marketing "non-menthol cooling cigarettes". Little is known about what current menthol smokers think of these non-menthol cooling cigarettes and how they compare to regular menthol cigarettes. By doing this study, the investigators hope to learn what menthol smokers think of these cigarettes and how they impact how menthol smokers smoke.
Detailed description
The Food and Drug Administration has been considering a potential federal restriction on menthol as a characterizing flavor in combustible cigarettes, a policy that would likely significantly reduce tobacco related disparities among Black adults who smoke menthol cigarette. However, in states where this policy has been enacted and menthol cigarettes are off the market, the tobacco industry has circumvented the restriction by introducing new non-menthol cigarettes that include WS-3, a chemical that acts as a cooling agent but without use of menthol. Our team is interested in understanding the extent to which WS-3 undermines a potential future menthol ban and the impact on the reduction in cigarettes smoked, particularly among Black adults who smoke.
The overall objective of this application is to obtain effect sizes and establish feasibility for an upcoming R01 submission. Specific aims include: Aim1: Determine the change in total cigarettes per day (CPD) when using menthol cigarettes, WS-3 cigarettes, and traditional non-menthol cigarettes. The primary comparison is between WS-3 and traditional non-menthol cigarettes. Aim 2: Understand the comparative abuse liability during ad libitum use of menthol cigarettes, WS-3 synthetic cooling agent cigarettes, and traditional non-menthol cigarettes. The study intervention involves providing study participants, who are all adult current smokers with no intention to quit or alter their cigarette smoking, with either menthol cigarettes, WS-3 synthetic cooling agent cigarettes, or traditional non-menthol cigarettes. All study products are commercially available. Participants will report on their usual number of cigarettes per day and will be provided a commensurate amount of study cigarettes to allow them to make a complete switch to the study product for the duration of the 6 week research study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be 20 adult current menthol smokers. Participants will be randomized to continued menthol smoking (n = 4), WS-3 synthetic cooling agent cigarette smoking (n = 8), or traditional non-menthol cigarette smoking (n = 8).
| Arm | Type | Receives |
|---|---|---|
| Continued menthol smoking | Active comparator | Other: Assigning menthol type cigarettesCurrent menthol smokers will be assigned to smoke study provided menthol cigarettes. |
| Synthetic cooling agent cigarette smoking | Experimental | Other: Assigning cooling agent type cigarettesCurrent menthol smokers will be assigned to smoke study provided synthetic cooling agent cigarettes. |
| Traditional non-menthol cigarette smoking | Experimental | Other: Assigning traditional tobacco type cigarettesCurrent menthol smokers will be assigned to smoke study provided traditional non-menthol cigarettes. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Current cigarette smoker
- Smoke at least 5 cigarettes per day
- Smoke on at least 25 of the past 30 days
- Smoke menthol cigarettes for at least 1 year
- At least 21 years old
Key exclusion criteria (7 listed)
- E-cigarette use on greater than 4 of the past 30 days
- Other tobacco product use on greater than 4 of the past 30 days
- Interested in quitting smoking (i.e., setting a quit date) in the next 30 day
- Current use of cessation medications
- Household member currently or previously enrolled in the study
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 |
|---|---|---|
| Assigning cooling agent type cigarettesThis study is intended to help understand what people who smoke menthol cigarettes would do in a scenario where the Food and Drug Administration bans menthol cigarettes but allows cooling agent cigarettes. | Other | Synthetic cooling agent cigarette smoking |
| Assigning traditional tobacco type cigarettesThis comparison group is intended to help understand what people who smoke menthol cigarettes would do in a scenario where the Food and Drug Administration bans menthol and cooling agent cigarettes. | Other | Traditional non-menthol cigarette smoking |
| Assigning menthol type cigarettesThis comparison group is for where the Food and Drug Administration does not ban menthol cigarettes. | Other | Continued menthol smoking |
Primary outcome
Cigarette changes from baseline to week 3
Time frame: 3 weeks
4.1 The primary study endpoint is changes in total cigarettes per day from baseline to week 3.
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 6 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Eleanor Leavens, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assigning cooling agent type cigarettes, Assigning traditional tobacco type cigarettes and Assigning menthol type cigarettes in people with Tobacco Dependence, run by University of Kansas Medical Center 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 14 inclusion and 7 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 6 Apr 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?
Cigarette changes from baseline to week 3 (time frame: 3 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 6 Apr 2025.