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

Medical University of South Carolina (MUSC)

Status: Enrolling

Conditions: Smoking Prevention and Control

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05896033

1R01DA055985-01A1 (U.S. NIH Grant/Contract)

00122898

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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240 participants in 4 patient groups

Menthol Spectrum Cigarettes and Menthol E-cigarettes

Experimental group

Description:

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.

Treatment:

Behavioral: Menthol Cigarettes

Behavioral: Menthol Flavored E-cigarettes

Menthol Spectrum Cigarettes and Tobacco E-cigarettes

Experimental group

Description:

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.

Treatment:

Behavioral: Menthol Cigarettes

Behavioral: Tobacco Flavored E-cigarettes

Non-menthol Spectrum Cigarettes and Menthol E-cigarettes

Experimental group

Description:

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.

Treatment:

Behavioral: Menthol Flavored E-cigarettes

Behavioral: Non-Menthol Cigarettes

Non-menthol Spectrum Cigarettes and Tobacco E-cigarettes

Experimental group

Description:

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.

Treatment:

Behavioral: Non-Menthol Cigarettes

Behavioral: Tobacco Flavored E-cigarettes