Impact of Cigarette and E-cigarette Menthol Regulation on Current Smokers of Menthol Cigarettes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-Menthol Cigarettes, Tobacco Flavored E-cigarettes, Menthol Cigarettes, Menthol Flavored E-cigarettes.
- Who it may be relevant to
- Registry conditions: Smoking Prevention and Control. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Impact of Menthol Regulation for Cigarettes and E-cigarettes on Tobacco Use Patterns for Current Menthol Smokers
Overview
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.
Interventions
- Behavioral Non-Menthol Cigarettes
Ppts will be randomly assigned to a group that receives non-menthol cigarettes - Behavioral Tobacco Flavored E-cigarettes
Ppts will be randomly assigned to a group that receives tobacco flavored e-cigarettes - Behavioral Menthol Cigarettes
Ppts will be randomly assigned to a group that receives menthol flavored cigarettes - Behavioral Menthol Flavored E-cigarettes
Ppts will be randomly assigned to a group that receives menthol flavored e-cigarettes
Primary outcome measures
- Changes in cigarettes per day [Time frame: Week 1- Week 6]
Secondary outcome measures (2)
- Fagerstrom Test for Nicotine Dependence [Time frame: Week 1- Week 7]
- Ability to abstain from smoking [Time frame: Week 7]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
- other tobacco and pharmacotherapy criteria
- health and safety criteria
- planning to move out of the area within the next 3 months
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Medical University of South Carolina — Charleston
Identifiers
NCT: NCT05896033 · 00122898 · 1R01DA055985-01A1