A Pilot RCT Exploring Heated Tobacco Product Substitution for Menthol Cigarettes

IF 4.5 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL
Augustus M. White PhD , Rabia Imran BA , Nicoleta Gaitan RN , Warren K. Bickel PhD , Robert A. Perera PhD , Caroline O. Cobb PhD , Thomas E. Eissenberg PhD , Andrew J. Barnes PhD
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引用次数: 0

Abstract

Introduction

Flavors are a key regulatory target for tobacco products, but little is known about how flavors influence the appeal of heated tobacco products, such as IQOS, for people who smoke. This study assessed differences in the substitution feasibility of menthol- and regular/tobacco-flavored IQOS for menthol cigarettes.

Study design

This was an unblinded 2-week, parallel-group randomized pilot clinical trial.

Setting/participants

Thirty adults who smoked menthol cigarettes in Richmond, VA completed clinical laboratory sessions (Monday and Friday) and reported at-home tobacco consumption. Data were collected from November 2022 to September 2023 and analyzed from October 2023 to February 2024.

Intervention

Participants were randomized to use IQOS 2.4 with fresh menthol (IQOS-M) or regular tobacco (IQOS-T) HeatSticks (1:1) during Week 2 of the study in the clinical laboratory and throughout the second week while they were at home.

Main outcome measures

Laboratory visits involved 10-puff directed use bouts with puff topography, plasma nicotine measurement, subjective effects questionnaires, and the Experimental Tobacco Marketplace task. The primary outcome was the cross-price elasticity of IQOS in the Experimental Tobacco Marketplace at the final clinical laboratory session. Electronic daily diaries measured tobacco consumption at home.

Results

In the Experimental Tobacco Marketplace, the average (SD) cross-price elasticity for IQOS was 0.67 (0.09) when IQOS-M and IQOS-T were available concurrently versus 0.14 (0.03) when only IQOS-T was available (p<0.05). At home, participants reduced their typical cigarette consumption by 80% when they had access to IQOS-M versus 37% with IQOS-T (p<0.05). Differences in puff topography and nicotine delivery across IQOS flavors were not significant (p>0.05).

Conclusions

Access to menthol-flavored heated tobacco products is an important determinant of potential substitution for people who smoke menthol cigarettes but may not be sufficient to promote complete substitution. Tobacco regulatory policies that restrict access to menthol-flavored heated tobacco products could promote complete tobacco cessation but may reduce attempts to substitute with heated tobacco products among people who smoke menthol cigarettes.

Trial registration

This trial was preregistered at www.clinicaltrials.gov (NCT05499377).
探索加热烟草产品替代薄荷香烟的试点随机对照试验。
简介:香料是烟草产品的关键监管目标,但人们对香料如何影响IQOS等加热烟草产品(htp)对吸烟者的吸引力知之甚少。本研究评估了薄荷味和普通/烟草味IQOS替代薄荷香烟可行性的差异。研究设计:两周无盲、平行组随机临床试验。环境/参与者:弗吉尼亚州里士满30名吸薄荷烟的成年人完成了临床实验室测试(周一和周五),并报告了在家吸烟的情况。数据收集时间为2022年11月至2023年9月,分析时间为2023年10月至2024年2月。干预:在临床实验室研究的第2周和整个第二周在家时,参与者被随机分配使用IQOS 2.4与新鲜薄荷醇(IQOS- m)或普通烟草(IQOS- t)热棒(1:1)。主要结果测量:实验室访问包括10支烟的直接使用,吸烟地形,血浆尼古丁测量,主观效应问卷调查和实验烟草市场(ETM)任务。主要结果是在最后的临床实验室阶段,ETM中IQOS的交叉价格弹性(CPE)。电子日记本测量了家中的烟草消费量。结果:在ETM中,IQOS- m和IQOS- t同时可用时的平均(SD) CPE为0.67(0.09),而仅IQOS- t可用时的平均(SD) CPE为0.14 (0.03)(p0.05)。结论:对于吸食薄荷香烟的人来说,获得薄荷味香烟是潜在替代的重要决定因素,但可能不足以促进完全替代。烟草管理政策限制获得薄荷味的高纯度烟草制品可以促进完全戒烟,但可能会减少吸烟薄荷香烟的人尝试用高纯度烟草制品替代。试验注册:该试验已在www.Clinicaltrials: gov (NCT05499377)上预注册。
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来源期刊
American Journal of Preventive Medicine
American Journal of Preventive Medicine 医学-公共卫生、环境卫生与职业卫生
CiteScore
8.60
自引率
1.80%
发文量
395
审稿时长
32 days
期刊介绍: The American Journal of Preventive Medicine is the official journal of the American College of Preventive Medicine and the Association for Prevention Teaching and Research. It publishes articles in the areas of prevention research, teaching, practice and policy. Original research is published on interventions aimed at the prevention of chronic and acute disease and the promotion of individual and community health. Of particular emphasis are papers that address the primary and secondary prevention of important clinical, behavioral and public health issues such as injury and violence, infectious disease, women''s health, smoking, sedentary behaviors and physical activity, nutrition, diabetes, obesity, and substance use disorders. Papers also address educational initiatives aimed at improving the ability of health professionals to provide effective clinical prevention and public health services. Papers on health services research pertinent to prevention and public health are also published. The journal also publishes official policy statements from the two co-sponsoring organizations, review articles, media reviews, and editorials. Finally, the journal periodically publishes supplements and special theme issues devoted to areas of current interest to the prevention community.
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