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Impact of Cigarette and E-cigarette Menthol Regulation on Current Smokers of Menthol Cigarettes

The Impact of Menthol Regulation for Cigarettes and E-cigarettes on Tobacco Use Patterns for Current Menthol Smokers

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05896033
Enrollment
240
Registered
2023-06-09
Start date
2023-10-23
Completion date
2027-08-31
Last updated
2026-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Prevention and Control

Keywords

Smoking, Menthol

Brief summary

In a 2x2 design, current menthol smokers (N=240) will complete a baseline period before being assigned to a cigarette (menthol or non-menthol) and e-cigarette condition (menthol or tobacco-flavored e-liquid) and receiving a 7-week supply of cigarettes and e-cigarettes. The study builds upon our well-established methodology for simulating tobacco regulatory policies. To model a ban, smokers will be instructed to only use their assigned products. Primary outcomes include cigarette smoking and e-cigarette use during Week 6. However, because a menthol ban may impact the ability to abstain from smoking, the investigators will incentivize participants to abstain from smoking during Week 7 (continued e-cigarette use allowed) and assess the time to first lapse. Participants will complete daily electronic diaries assessing tobacco product use throughout, which will be corroborated by biomarkers for menthol, nicotine, and smoke. Finally, to maximize the utility of these data for FDA regulation, the investigators will assess whether any demographic or baseline smoking characteristics moderate the observed treatment effects, calibrate the treatment effects to the US adult menthol smoking population, and model the effects of menthol regulation in cigarettes and e-cigarettes on smoking and vaping-attributable deaths and life-years lost.

Interventions

BEHAVIORALNon-Menthol Cigarettes

Ppts will be randomly assigned to a group that receives non-menthol cigarettes

BEHAVIORALTobacco Flavored E-cigarettes

Ppts will be randomly assigned to a group that receives tobacco flavored e-cigarettes

BEHAVIORALMenthol Cigarettes

Ppts will be randomly assigned to a group that receives menthol flavored cigarettes

BEHAVIORALMenthol Flavored E-cigarettes

Ppts will be randomly assigned to a group that receives menthol flavored e-cigarettes

Sponsors

Medical University of South Carolina
Lead SponsorOTHER
National Institutes of Health (NIH)
CollaboratorNIH
University of Minnesota
CollaboratorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. adults (21+) who a) have been smoking at least 5 cigarettes daily for one year 2. usual brand (the brand used most often) is mentholated 3. have a smartphone that can receive text messages and access the internet (necessary for diary completion).

Exclusion criteria

1. other tobacco and pharmacotherapy criteria 2. health and safety criteria 3. planning to move out of the area within the next 3 months

Design outcomes

Primary

MeasureTime frameDescription
Changes in cigarettes per dayWeek 1- Week 6Will be measured through week 6 of the study

Secondary

MeasureTime frameDescription
Fagerstrom Test for Nicotine DependenceWeek 1- Week 7Cigarette Dependence
Ability to abstain from smokingWeek 7Participants will complete a 1-week practice quit attempt in week 7; time to first smoking lapse will be assessed.

Countries

United States

Contacts

CONTACTTracy T Smith
smithtra@musc.edu8437925164

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 22, 2026