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

NCT ID: NCT05896033

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-23
• Study Completion Date: 2027-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Menthol Cigarettes

Intervention Type: BEHAVIORAL

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

Menthol Flavored E-cigarettes

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Tobacco Flavored E-cigarettes

Intervention Type: BEHAVIORAL

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

Menthol Cigarettes

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Non-Menthol Cigarettes

Intervention Type: BEHAVIORAL

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

Menthol Flavored E-cigarettes

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Non-Menthol Cigarettes

Intervention Type: BEHAVIORAL

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

Tobacco Flavored E-cigarettes

Intervention Type: BEHAVIORAL

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

Interventions

Non-Menthol Cigarettes

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

Intervention Type: BEHAVIORAL

Tobacco Flavored E-cigarettes

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

Intervention Type: BEHAVIORAL

Menthol Cigarettes

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

Intervention Type: BEHAVIORAL

Menthol Flavored E-cigarettes

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Tracy Smith

Associate Professor-Faculty

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Tracy T Smith

Role: CONTACT

smithtra@musc.edu

8437925164

Facility Contacts

Tracy Smith, PhD

Role: primary

smithtra@musc.edu

8437925164

Other Identifiers

1R01DA055985-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00122898

Identifier Type: -

Identifier Source: org_study_id