Cooling Agent Pilot Among Adult Menthol Smokers

NCT ID: NCT06477601

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-24
• Study Completion Date: 2024-10-01

Brief 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". 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.

Conditions

Tobacco Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Continued menthol smoking

Current menthol smokers will be assigned to smoke study provided menthol cigarettes.

Group Type: ACTIVE_COMPARATOR

Assigning menthol type cigarettes

Intervention Type: OTHER

This comparison group is for where the Food and Drug Administration does not ban menthol cigarettes.

Synthetic cooling agent cigarette smoking

Current menthol smokers will be assigned to smoke study provided synthetic cooling agent cigarettes.

Group Type: EXPERIMENTAL

Assigning cooling agent type cigarettes

Intervention Type: OTHER

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.

Traditional non-menthol cigarette smoking

Current menthol smokers will be assigned to smoke study provided traditional non-menthol cigarettes.

Group Type: EXPERIMENTAL

Assigning traditional tobacco type cigarettes

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Assigning menthol type cigarettes

This comparison group is for where the Food and Drug Administration does not ban menthol cigarettes.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eleanor Leavens, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

University of Kansas Tobacco Treatment Center

Kansas City, Missouri, United States

Countries

United States

Other Identifiers

160670

Identifier Type: -

Identifier Source: org_study_id