Recruiting

Cigarette Regulation

Sponsor:

Medical University of South Carolina

Code:

NCT05896033

Conditions

Smoking Prevention and Control

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

Non-Menthol Cigarettes

Tobacco Flavored E-cigarettes

Menthol Cigarettes

Menthol Flavored E-cigarettes

Study Details

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 ID

NCT05896033

Start date

Oct 23, 2023

Status verified date

Jul, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

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

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

Interventions

Non-Menthol Cigarettes

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

Tobacco Flavored E-cigarettes

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

Menthol Cigarettes

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

Menthol Flavored E-cigarettes

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

Primary outcome measure

  • Changes in cigarettes per day [ Time Frame: Week 1- Week 6 ]

Central Contacts and Locations

Central contacts

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

More Information

Sponsor

Medical University of South Carolina

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Keywords

  • Smoking
  • Menthol

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-07-21.