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

NCT05896033 | Recruiting DMC

• 2 other identifiers: 001228981R01DA055985-01A1
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Prevention and Control

Keywords

Smoking; Menthol

Outcome Measures

Primary Outcomes (1)

• Changes in cigarettes per day

  Will be measured through week 6 of the study

  Week 1- Week 6

Secondary Outcomes (2)

• Fagerstrom Test for Nicotine Dependence

  Week 1- Week 7

• Ability to abstain from smoking

  Week 7

Study Arms (4)

Menthol Spectrum Cigarettes and Menthol E-cigarettes

EXPERIMENTAL

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; Behavioral: Menthol Flavored E-cigarettes

Menthol Spectrum Cigarettes and Tobacco E-cigarettes

EXPERIMENTAL

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: Tobacco Flavored E-cigarettes; Behavioral: Menthol Cigarettes

Non-menthol Spectrum Cigarettes and Menthol E-cigarettes

EXPERIMENTAL

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: Non-Menthol Cigarettes; Behavioral: Menthol Flavored E-cigarettes

Non-menthol Spectrum Cigarettes and Tobacco E-cigarettes

EXPERIMENTAL

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: Non-Menthol Cigarettes; Behavioral: Tobacco Flavored E-cigarettes

Interventions

Non-Menthol Cigarettes BEHAVIORAL

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

Non-menthol Spectrum Cigarettes and Menthol E-cigarettes; Non-menthol Spectrum Cigarettes and Tobacco E-cigarettes

Tobacco Flavored E-cigarettes BEHAVIORAL

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

Menthol Spectrum Cigarettes and Tobacco E-cigarettes; Non-menthol Spectrum Cigarettes and Tobacco E-cigarettes

Menthol Cigarettes BEHAVIORAL

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

Menthol Spectrum Cigarettes and Menthol E-cigarettes; Menthol Spectrum Cigarettes and Tobacco E-cigarettes

Menthol Flavored E-cigarettes BEHAVIORAL

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

Menthol Spectrum Cigarettes and Menthol E-cigarettes; Non-menthol Spectrum Cigarettes and Menthol E-cigarettes

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institutes of Health (NIH): collaborator
• University of Minnesota: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Tracy T Smith

CONTACT

8437925164; smithtra@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: June 9, 2023
• Study Start: October 23, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: July 21, 2026

Record last verified: 2026-07

Locations

US (1)