Level and timing of product substitution in a trial of e-cigarettes for smokers not interested in quitting.

IF 2.2 4区医学 Q2 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Tobacco Induced Diseases Pub Date : 2024-06-13 eCollection Date: 2024-01-01 DOI:10.18332/tid/189220

James D Sargent, Sarah I Pratt, Mary F Brunette, Joelle C Ferron, Meghan M Santos, Mike Stoolmiller

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Abstract

Introduction: The e-cigarette market is large and diverse. Traditional smoking cessation trials involving a control group and a 6-month observation period are an inefficient methodology for testing the multiple treatment options e-cigarettes provide for harm reduction in cigarette smokers. We determined when product substitution occurred in the e-cigarette provision arm of an e-cigarette substitution trial for cigarette smokers who were not interested in quitting.

Methods: We conducted a secondary analysis of 120 cigarette smokers with severe mental illness (recruitment 2017-2020) who were given disposable e-cigarettes for 8 weeks and assessed at weeks 0 (t0), 2, 4, 6, and 8. We explored product substitution through visit-to-visit correlations in change in product use, then developed a dual process growth model for cigarette and e-cigarette use to test the association between increases in e-cigarette use and concurrent decreases in cigarettes smoked.

Results: Mean age of the participants was 45.9 years, and 42.7% smoked ≥20 cigarettes per day. Almost all product substitution occurred between t0 and t2. For the average smoker (18 cigarettes per day), t2 cigarette frequency decreased by 0.39 (95% CI: -0.56 - -0.22) cigarettes for each additional e-cigarette session. There was effect modification (p=0.033), such that baseline light smokers (<10 cigarettes/day) had no significant decrease in t2 cigarette frequency, regardless of their initial increase in e-cigarette use, while heavy smokers (38 cigarettes/day) switched products nearly on a one-to-one basis.

Conclusions: In this study, most product substitution occurred early, and heavier smokers had larger t2 decreases in cigarettes/day with increased e-cigarette use. If confirmed with replication studies, the findings could suggest establishment of a novel outcome for e-cigarette studies - early product substitution - and support the value of short-term comparative effectiveness trials that compare multiple potentially lower harm tobacco products.

Clinical trial registration: The study was registered on the official website of ClinicalTrials.gov.

Identifier: ID NCT03050853.

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针对无意戒烟者的电子烟试验中产品替代的程度和时间。

介绍：电子烟市场规模庞大，种类繁多。传统的戒烟试验包括一个对照组和 6 个月的观察期，对于测试电子烟为卷烟吸烟者提供的多种减害治疗方案来说，这种方法效率不高。我们确定了在一项针对无意戒烟的吸烟者的电子烟替代试验中，提供电子烟的一方何时进行了产品替代：我们对 120 名患有严重精神疾病的吸烟者（招募时间为 2017-2020 年）进行了二次分析，这些吸烟者接受了为期 8 周的一次性电子烟，并在第 0 周（t0）、第 2 周、第 4 周、第 6 周和第 8 周接受了评估。我们通过访问与访问之间产品使用变化的相关性探索了产品替代情况，然后建立了一个香烟和电子烟使用的双过程增长模型，以检验电子烟使用增加与同时吸烟量减少之间的关联：参与者的平均年龄为 45.9 岁，42.7% 的人每天吸烟≥20 支。几乎所有的产品替代都发生在 t0 和 t2 之间。对于普通吸烟者（每天吸烟 18 支）而言，每增加一次吸电子烟的次数，t2 吸烟次数就会减少 0.39 支（95% CI：-0.56 -0.22）。存在效应修正（p=0.033），例如，基线轻度吸烟者（结论：吸烟者的吸烟频率在每增加一次吸电子烟的次数后会降低0.39支（95% CI：-0.56 -0.22））：在这项研究中，大多数产品的替代发生在早期，随着电子烟使用量的增加，烟瘾较大的吸烟者每天吸烟量的t2下降幅度较大。如果通过重复研究得到证实，这些发现将为电子烟研究提供一个新的结果--早期产品替代--并支持对多种潜在危害较低的烟草产品进行比较的短期比较有效性试验的价值：该研究已在ClinicalTrials.gov.Identifier：ID NCT03050853。

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来源期刊

Tobacco Induced Diseases SUBSTANCE ABUSE-PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH

CiteScore

5.30

自引率

5.40%

发文量

审稿时长

12 weeks

期刊介绍： Tobacco Induced Diseases encompasses all aspects of research related to the prevention and control of tobacco use at a global level. Preventing diseases attributable to tobacco is only one aspect of the journal, whose overall scope is to provide a forum for the publication of research articles that can contribute to reducing the burden of tobacco induced diseases globally. To address this epidemic we believe that there must be an avenue for the publication of research/policy activities on tobacco control initiatives that may be very important at a regional and national level. This approach provides a very important "hands on" service to the tobacco control community at a global scale - as common problems have common solutions. Hence, we see ourselves as "connectors" within this global community. The journal hence encourages the submission of articles from all medical, biological and psychosocial disciplines, ranging from medical and dental clinicians, through health professionals to basic biomedical and clinical scientists.