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

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.

Study Overview

• Status: Recruiting
• Conditions: Smoking Prevention and Control
• Intervention / Treatment: Behavioral: Menthol Cigarettes; Behavioral: Menthol Flavored E-cigarettes; Behavioral: Tobacco Flavored E-cigarettes; Behavioral: Non-Menthol Cigarettes

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tracy T Smith; Phone Number: 8437925164; Email: smithtra@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
      • Contact: Tracy Smith, PhD; Phone Number: 8437925164; Email: smithtra@musc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Menthol Spectrum Cigarettes and Menthol E-cigarettes; Ppts will be randomly assigned to receive the menthol spectrum cigarettes and Njoy Ace menthol e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit.	Behavioral: Menthol Cigarettes; Ppts will be randomly assigned to a group that receives menthol flavored cigarettes; Behavioral: Menthol Flavored E-cigarettes; Ppts will be randomly assigned to a group that receives menthol flavored e-cigarettes
Experimental: Menthol Spectrum Cigarettes and Tobacco E-cigarettes; Ppts will be randomly assigned to receive the menthol spectrum cigarettes and Njoy Ace tobacco e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit.	Behavioral: Menthol Cigarettes; Ppts will be randomly assigned to a group that receives menthol flavored cigarettes; Behavioral: Tobacco Flavored E-cigarettes; Ppts will be randomly assigned to a group that receives tobacco flavored e-cigarettes
Experimental: Non-menthol Spectrum Cigarettes and Menthol E-cigarettes; Ppts will be randomly assigned to receive the non-menthol spectrum cigarettes and Njoy Ace menthol e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit.	Behavioral: Menthol Flavored E-cigarettes; Ppts will be randomly assigned to a group that receives menthol flavored e-cigarettes; Behavioral: Non-Menthol Cigarettes; Ppts will be randomly assigned to a group that receives non-menthol cigarettes
Experimental: Non-menthol Spectrum Cigarettes and Tobacco E-cigarettes; Ppts will be randomly assigned to receive the non-menthol spectrum cigarettes and Njoy Ace tobacco e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit.	Behavioral: Tobacco Flavored E-cigarettes; Ppts will be randomly assigned to a group that receives tobacco flavored e-cigarettes; Behavioral: Non-Menthol Cigarettes; Ppts will be randomly assigned to a group that receives non-menthol cigarettes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in cigarettes per day	Will be measured through week 6 of the study	Week 1- Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fagerstrom Test for Nicotine Dependence	Cigarette Dependence	Week 1- Week 7
Ability to abstain from smoking	Participants will complete a 1-week practice quit attempt in week 7; time to first smoking lapse will be assessed.	Week 7

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: National Institute on Drug Abuse (NIDA); National Institutes of Health (NIH); University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: May 19, 2023
• First Submitted That Met QC Criteria: May 30, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Smoking; Menthol
• Additional Relevant MeSH Terms: Behavior; Smoking; Dermatologic Agents; Antipruritics; Menthol
• Other Study ID Numbers: 00122898; 1R01DA055985-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No