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Completed

NCT Number: NCT05259566

Potential Impact of Menthol Ban in Cigarettes and E-cigarettes

Menthol cigarette use remains a major public health problem and the FDA has proposed to ban menthol in cigarettes. However, additional evidence is needed to understand whether menthol flavor in e-cigarettes is important for harm reduction among menthol cigarette smokers in the context of a menthol cigarette ban. The primary aim of this project is to understand how the availability of menthol vs tobacco flavor e-cigarettes influences switching and reduces smoking behavior among adults who currently smoke menthol cigarettes to understand the potential effects in the context of a ban of menthol cigarettes.

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Key information

Conditions

Tobacco Smoking Behavior Smoking Tobacco Use Vaping

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University

New Haven, Connecticut, 06520, United States

About this study

Menthol cigarette use remains a major public health problem and the FDA has proposed to ban menthol in cigarettes. However, additional evidence is needed to understand whether menthol flavor in e-cigarettes is important for harm reduction among menthol cigarette smokers in the context of a menthol cigarette ban.

The primary aim of this project is to understand how the availability of menthol vs tobacco flavor e-cigarettes influences switching and reduces smoking behavior among adults who currently smoke menthol cigarettes to understand the potential effects in the context of a ban of menthol cigarettes. The secondary aim of this project is to understand whether smoking behavior outcomes differ by race to understand the impact of these potential menthol ban policies on addressing tobacco-related health disparities.

This single site study will take place over a 4 year study period; approximately 14 weeks for each participant's completion.

150 adults who currently smoke menthol cigarettes will be enrolled and prospectively randomized using a randomization ratio of 1:1:1 to 1 of 3 groups (N=50 per group). Following an initial baseline period where participants have access to their usual menthol cigarettes (Phase I), participants will receive tobacco products to use for 8 weeks based on their assigned group modeling 3 possible regulatory scenarios (Phase II): 1) no menthol ban (menthol cigarettes and e-cigarettes available), 2) menthol ban in cigarettes only (non-menthol cigarettes and menthol e-cigarettes available), 3) menthol ban in both cigarettes and e-cigarettes (non-menthol cigarettes and tobacco e-cigarettes available). A follow-up survey at week 12 will assess tobacco use outcomes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Provision of signed and dated informed consent form
  • Age 21 or older
  • Able to read English
  • Currently smoking cigarettes
  • Willing to try e-cigarettes
  • In good general health

Exclusion criteria

  • Seeking smoking cessation treatment
  • Serious psychiatric or medical condition
  • Use of other drugs
  • Unable or unwilling to complete study protocol
  • Contraindications for study procedures based on medical history

Treatment and study plan

menthol ban in cigarettes only

Behavioral

menthol ban in cigarettes only, menthol available in e-cigarette

total menthol ban

Behavioral

menthol ban in both cigarettes and e-cigarettes

Primary outcomes

  1. Average number of cigarettes smoked per day in the past week to evaluate changes in smoking behavior

    Time frame: From Week 0 to week 8

    Participants will report the total number of cigarettes consumed each day using the well-validated timeline follow-back (TLFB) interview methods to assess change.

Secondary outcomes

  1. Percent days smoke-free

    Time frame: From Week 0 to week 8

    Participants will report the number of smoke free days over the 8 week study period. Percent days smoke-free will be determined using the TLFB interview methods.

  2. Changes in nicotine dependence using the Nicotine Dependence for Daily Smokers Scale

    Time frame: From Week 0 to week 8

    Changes in nicotine dependence will be measured using the Nicotine Dependence for Daily Smokers Scale from the NIH Patient Reported Outcome Measure Information System (PROMIS) bank. Scores are averaged across 4 items, min=1, max=5. Higher scores indicate greater nicotine dependence.

  3. Change in Quitting motivation and confidence

    Time frame: Week 0 and week 8

    Quitting motivation and confidence will be assessed using the PhenX Toolkit using the items "How motivated are you to quit smoking?" and "How confident are you that you could quit smoking if you tried?" rated from 1 (not at all) to 10 (extremely).

Other outcomes

  1. Percent days of e-cigarette use

    Time frame: From Week 0 to week 8

    Participants will report the number of days using the e-cigarette over the 8 week study period using the TLFB interview

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Evaluating the Potential Impact of a Menthol Ban in Cigarettes and E-cigarettes Among Current Menthol Smokers

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 28, 2022
Registry last updated
Jun 22, 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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