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

Not Applicable

Recruiting

• Conditions: Smoking Prevention and Control
• Interventions: Behavioral: Non-Menthol Cigarettes; Behavioral: Menthol Cigarettes; Behavioral: Tobacco Flavored E-cigarettes; Behavioral: Menthol Flavored E-cigarettes

• Registration Number: NCT05896033
• Lead Sponsor: Medical University of South Carolina

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-19
• Study First Submitted QC: 2023-05-30
• Study First Posted: 2023-06-09
• Study Start: 2023-10-23
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-05
• Primary Completion: 2027-06-30
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Non-menthol Spectrum Cigarettes and Tobacco E-cigarettes	Non-Menthol 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.
Non-menthol Spectrum Cigarettes and Tobacco E-cigarettes	Tobacco Flavored 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.
Menthol Spectrum Cigarettes and Menthol E-cigarettes	Menthol 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.
Menthol Spectrum Cigarettes and Tobacco E-cigarettes	Tobacco Flavored 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.
Menthol Spectrum Cigarettes and Menthol E-cigarettes	Menthol Flavored 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.
Menthol Spectrum Cigarettes and Tobacco E-cigarettes	Menthol 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.
Non-menthol Spectrum Cigarettes and Menthol E-cigarettes	Menthol Flavored 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.
Non-menthol Spectrum Cigarettes and Menthol E-cigarettes	Non-Menthol 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.

Primary Outcome Measures

Name	Time	Method
Changes in cigarettes per day	Week 1- Week 6	Will be measured through week 6 of the study

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States