跳至主要内容
临床试验/NCT05259566
NCT05259566已完成不适用

Evaluating the Potential Impact of a Menthol Ban in Cigarettes and E-cigarettes Among Current Menthol Smokers

Yale University1 个研究点 分布在 1 个国家目标入组 151 人开始时间: 2022年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
151
试验地点
1
主要终点
Average number of cigarettes smoked per day in the past week to evaluate changes in smoking behavior

研究概览

简要总结

Menthol cigarette use remains a major public health problem and the FDA has proposed to ban menthol in cigarettes. However, additional evidence is needed to understand whether menthol flavor in e-cigarettes is important for harm reduction among menthol cigarette smokers in the context of a menthol cigarette ban. The primary aim of this project is to understand how the availability of menthol vs tobacco flavor e-cigarettes influences switching and reduces smoking behavior among adults who currently smoke menthol cigarettes to understand the potential effects in the context of a ban of menthol cigarettes.

详细描述

Menthol cigarette use remains a major public health problem and the FDA has proposed to ban menthol in cigarettes. However, additional evidence is needed to understand whether menthol flavor in e-cigarettes is important for harm reduction among menthol cigarette smokers in the context of a menthol cigarette ban.

The primary aim of this project is to understand how the availability of menthol vs tobacco flavor e-cigarettes influences switching and reduces smoking behavior among adults who currently smoke menthol cigarettes to understand the potential effects in the context of a ban of menthol cigarettes. The secondary aim of this project is to understand whether smoking behavior outcomes differ by race to understand the impact of these potential menthol ban policies on addressing tobacco-related health disparities.

This single site study will take place over a 4 year study period; approximately 14 weeks for each participant's completion.

150 adults who currently smoke menthol cigarettes will be enrolled and prospectively randomized using a randomization ratio of 1:1:1 to 1 of 3 groups (N=50 per group). Following an initial baseline period where participants have access to their usual menthol cigarettes (Phase I), participants will receive tobacco products to use for 8 weeks based on their assigned group modeling 3 possible regulatory scenarios (Phase II): 1) no menthol ban (menthol cigarettes and e-cigarettes available), 2) menthol ban in cigarettes only (non-menthol cigarettes and menthol e-cigarettes available), 3) menthol ban in both cigarettes and e-cigarettes (non-menthol cigarettes and tobacco e-cigarettes available). A follow-up survey at week 12 will assess tobacco use outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Provision of signed and dated informed consent form
  • Age 21 or older
  • Able to read English
  • Currently smoking cigarettes
  • Willing to try e-cigarettes
  • In good general health

排除标准

  • Seeking smoking cessation treatment
  • Serious psychiatric or medical condition
  • Use of other drugs
  • Unable or unwilling to complete study protocol
  • Contraindications for study procedures based on medical history

研究组 & 干预措施

no menthol ban

No Intervention

usual menthol cigarettes and menthol flavored e-cigarette available

menthol ban in cigarettes only

Experimental

non-menthol cigarettes and menthol flavored e-cigarette available

干预措施: menthol ban in cigarettes only (Behavioral)

menthol ban in both cigarettes and e-cigarettes

Experimental

non-menthol cigarettes and tobacco flavored e-cigarette available,

干预措施: total menthol ban (Behavioral)

结局指标

主要结局

Average number of cigarettes smoked per day in the past week to evaluate changes in smoking behavior

时间窗: From Week 0 to week 8

Participants will report the total number of cigarettes consumed each day using the well-validated timeline follow-back (TLFB) interview methods to assess change.

次要结局

  • Changes in nicotine dependence using the Nicotine Dependence for Daily Smokers Scale(From Week 0 to week 8)
  • Quit intentions using the Stages of Change Assessment(Week 8)
  • Percent days smoke-free(From Week 0 to week 8)
  • Change in Quitting motivation and confidence(Week 0 and week 8)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Potential Impact of Menthol Ban in Cigarettes and... | 临床试验