Cooling Agent Pilot Among Adult Menthol Smokers

NCT06477601 | Completed

• 1 other identifier: 160670
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Dependence

Keywords

tobacco

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Continued menthol smoking

ACTIVE COMPARATOR

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

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.

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.

Other: Assigning traditional tobacco type cigarettes

Interventions

Assigning cooling agent type cigarettes 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.

Synthetic cooling agent cigarette smoking

Assigning traditional tobacco type cigarettes 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.

Traditional non-menthol cigarette smoking

Assigning menthol type cigarettes OTHER

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

Continued menthol smoking

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Tobacco Treatment Center

Kansas City, Missouri, 64130, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Eleanor Leavens, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants and investigators will be blind during randomization. Participants will be randomly assigned to their arm, but once assigned, participants and investigators will know which product they have been assigned to.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: June 27, 2024
• Study Start: June 24, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)