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NCT Number: NCT05896033

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

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location status: Recruiting

Location contact

Tracy Smith, PhD

CONTACT

[email protected]

843-792-5164

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Non-Menthol Cigarettes

Behavioral

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

Tobacco Flavored E-cigarettes

Behavioral

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

Menthol Cigarettes

Behavioral

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

Menthol Flavored E-cigarettes

Behavioral

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

Primary outcomes

  1. Changes in cigarettes per day

    Time frame: Week 1- Week 6

    Will be measured through week 6 of the study

Secondary outcomes

  1. Fagerstrom Test for Nicotine Dependence

    Time frame: Week 1- Week 7

    Cigarette Dependence

  2. Ability to abstain from smoking

    Time frame: Week 7

    Participants will complete a 1-week practice quit attempt in week 7; time to first smoking lapse will be assessed.

Study contacts

Contact information is provided by the study sponsor or research team.

Tracy T Smith

CONTACT

[email protected]

8437925164

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • National Institutes of Health (NIH)
  • University of Minnesota

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 9, 2023
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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