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

Официальное название

The Impact of Menthol Regulation for Cigarettes and E-cigarettes on Tobacco Use Patterns for Current Menthol Smokers

Обзор

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.

Вмешательства

• Поведенческое Non-Menthol Cigarettes
  Ppts will be randomly assigned to a group that receives non-menthol cigarettes
• Поведенческое Tobacco Flavored E-cigarettes
  Ppts will be randomly assigned to a group that receives tobacco flavored e-cigarettes
• Поведенческое Menthol Cigarettes
  Ppts will be randomly assigned to a group that receives menthol flavored cigarettes
• Поведенческое Menthol Flavored E-cigarettes
  Ppts will be randomly assigned to a group that receives menthol flavored e-cigarettes

Первичные конечные точки

• Changes in cigarettes per day [Срок оценки: Week 1- Week 6]

Вторичные конечные точки (2)

• Fagerstrom Test for Nicotine Dependence [Срок оценки: Week 1- Week 7]
• Ability to abstain from smoking [Срок оценки: Week 7]

Критерии участия

Критерии включения

• 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).

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Medical University of South Carolina — Charleston

Идентификаторы

NCT: NCT05896033 · 00122898 · 1R01DA055985-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗