Cooling Agent Pilot Among Adult Menthol Smokers

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Dependence
• Intervention / Treatment: Other: Assigning menthol type cigarettes; Other: Assigning cooling agent type cigarettes; Other: Assigning traditional tobacco type cigarettes

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64130
      • University of Kansas Tobacco Treatment Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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
• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Continued menthol smoking; Current menthol smokers will be assigned to smoke study provided menthol cigarettes.	Other: Assigning menthol type cigarettes; This comparison group is for where the Food and Drug Administration does not ban menthol cigarettes.
Experimental: Synthetic cooling agent cigarette smoking; Current menthol smokers will be assigned to smoke study provided synthetic cooling agent cigarettes.	Other: Assigning cooling agent type cigarettes; 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.
Experimental: Traditional non-menthol cigarette smoking; Current menthol smokers will be assigned to smoke study provided traditional non-menthol cigarettes.	Other: Assigning traditional tobacco type cigarettes; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 weeks

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Eleanor Leavens, PhD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2024
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: June 21, 2024
• First Submitted That Met QC Criteria: June 21, 2024
• First Posted (Actual): June 27, 2024

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: tobacco
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Tobacco Use Disorder; Dermatologic Agents; Antipruritics; Menthol
• Other Study ID Numbers: 160670

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No