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临床试验/NCT07092501
NCT07092501已完成不适用

An Experimental Evaluation of Menthol-Flavored Tobacco Accessories: Subjective Effects and Purchasing Behavior

Virginia Polytechnic Institute and State University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年9月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
Modified Cigarette Evaluation Questionnaire (mCEQ)

研究概览

简要总结

In a within-subjects design in-laboratory study, participants will sample non-menthol cigarettes mentholated with various accessories (e.g., crush balls, filter tips, aroma cards) in a controlled setting. They will compare these to their preferred menthol brand using subjective ratings (e.g., liking, strength, ease of use) and complete purchase tasks and ETM trials to assess product demand and likelihood of future use.

详细描述

Cigarette smoking remains the leading preventable cause of death and disease in the United States (US), accounting for half a million deaths per year and nearly 30% of all cancer deaths. More than 28 million US adults smoke daily, 35% of whom smoke menthol flavored cigarettes. Menthol cigarettes are linked to increased risk of smoking initiation and reduced likelihood of cessation. In addition to increased product appeal and attractiveness, menthol's cooling properties may induce misperceptions of reduced harm and mask early symptoms of respiratory disease. A cohort study (N ≈ 1 million) by the American Cancer Society found that former menthol smokers had a 12-43% higher risk of all-cause and heart disease mortality compared to former non-menthol smokers.

Efforts to reduce the appeal of cigarettes have been enacted worldwide, with several countries adopting regulatory policies on menthol flavor in tobacco products. In the US, state and local governments have been leading these tobacco control efforts, with over 140 localities implementing a menthol cigarette ban as of December 2024, including California and Massachusetts. Menthol bans have been effective in reducing smoking prevalence and increasing cessation rates. Nonetheless, at least one-third of menthol smokers continue to smoke after a menthol ban. A key contributor is the tobacco industry's promotion of mentholation accessories - including crush balls, filter tips, aroma cards - that consumers can use to flavor non-menthol cigarettes after purchase. These accessories, often nicotine-free and sold separately from tobacco products, fall outside the scope of tobacco regulations and have grown in popularity in jurisdictions with bans. Studies indicate that up to 40% of pre-ban menthol smokers may adopt these accessories after restrictions take effect, undermining public health objectives.

In this study, the investigators will experimentally examine subjective ratings of non-menthol cigarettes, flavored with various menthol-flavor accessories (e.g., crush balls, filter tips, aroma cards), compared to participants' own preferred brand of menthol cigarettes and non-menthol cigarettes equivalent.

In a within-subject design, menthol cigarette smokers will sample non-menthol cigarettes mentholated with menthol-flavor accessories (e.g., crush balls, filter tips, aroma cards), non-menthol cigarettes and their own cigarettes. Participants will provide subjective ratings of each product (e.g., liking, strength, ease of use) in comparison to their usual menthol cigarette brand. They will complete hypothetical cross-commodity purchase tasks and will complete one control trial and two ETM conditions representing different levels of restriction on menthol flavor in cigarettes. Within each condition, the investigators will manipulate availability of products and observe purchasing patterns across tobacco products and menthol-flavored accessories.

The study will consist of one in-lab visit. The study phases include: 1) Screening Phase; 2) Consent and assessments; 3) Sampling and subjective ratings assessments, and 4) ETM and hypothetical purchasing trials.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

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

  • Provide informed consent
  • Be a menthol cigarette smoker
  • Be at least 21 years of age or older
  • Provide a breath sample for measuring carbon monoxide (CO ≥ 8 ppm)
  • Smoke at least 10 cigarettes daily
  • Use other tobacco products less than weekly

排除标准

  • Have uncontrolled physical or mental health conditions
  • Use of smoking cessation medications (e.g., nicotine replacement, bupropion, varenicline) in the past 30 days
  • Report concrete, immediate plans to alter/quit using their usual tobacco products in the next 30 days
  • If they are pregnant or lactating
  • Have plans to move out of the area during the experiment

研究组 & 干预措施

Menthol cigarette smokers

Experimental

Menthol cigarette smokers will sample non-menthol cigarettes mentholated using menthol-flavored accessories (e.g., crush balls, filter tips, aroma cards), non-menthol cigarettes and their own cigarettes. Participants will provide subjective ratings of each product (e.g., liking, strength, ease of use) in comparison to their usual menthol cigarette brand. They will complete hypothetical cross-commodity purchase tasks and ETM trials to assess product demand and likelihood of use in different conditions.

干预措施: Subjective value assessment (Behavioral)

Menthol cigarette smokers

Experimental

Menthol cigarette smokers will sample non-menthol cigarettes mentholated using menthol-flavored accessories (e.g., crush balls, filter tips, aroma cards), non-menthol cigarettes and their own cigarettes. Participants will provide subjective ratings of each product (e.g., liking, strength, ease of use) in comparison to their usual menthol cigarette brand. They will complete hypothetical cross-commodity purchase tasks and ETM trials to assess product demand and likelihood of use in different conditions.

干预措施: Mentholated cigarette sampling (Behavioral)

Menthol cigarette smokers

Experimental

Menthol cigarette smokers will sample non-menthol cigarettes mentholated using menthol-flavored accessories (e.g., crush balls, filter tips, aroma cards), non-menthol cigarettes and their own cigarettes. Participants will provide subjective ratings of each product (e.g., liking, strength, ease of use) in comparison to their usual menthol cigarette brand. They will complete hypothetical cross-commodity purchase tasks and ETM trials to assess product demand and likelihood of use in different conditions.

干预措施: Hypothetical Policy Scenarios (Behavioral)

结局指标

主要结局

Modified Cigarette Evaluation Questionnaire (mCEQ)

时间窗: Day 1

Participants will provide the subjective ratings (e.g. liking, strength, ease of use) of each product in comparison to their usual menthol cigarette brand. The scale ranges from not at all (1) to extremely (7). Four factor scoring comprising stimulant effects (sum of items 5, 7 and 8, range from 3 to 21), positive reinforcement (sum of items 2, 3 and 12, range from 3 to 21), negative reinforcement (sum of items 4, 6 and 11, range from 3 to 21) and aversion (sum of items 9 and 10, range from 2 to 14). High scores represents higher positive effects for the first 3 factor and higher negative effect for the last factor.

次要结局

  • Own-price and cross-price demand intensity (q0)(Day 1)
  • Own-price and cross-price demand elasticity (alpha)(Day 1)
  • Own-price and cross-price demand breakpoint(Day 1)
  • Own-price and cross-price demand Pmax(Day 1)
  • Experimental Tobacco Marketplace purchase patterns(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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