Sargent James D, Pratt Sarah I, Brunette Mary F, Ferron Joelle C, Santos Meghan M, Stoolmiller Mike
Department of Pediatrics, Geisel School of Medicine, Dartmouth College, Hanover, United States.
Department of Biomedical Data Sciences, Geisel School of Medicine, Dartmouth College, Hanover, United States.
Tob Induc Dis. 2024 Jun 13;22. doi: 10.18332/tid/189220. eCollection 2024.
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.
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.
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.
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.
The study was registered on the official website of ClinicalTrials.gov.
ID NCT03050853.
电子烟市场规模庞大且种类繁多。涉及对照组和6个月观察期的传统戒烟试验，对于测试电子烟为减少吸烟者危害所提供的多种治疗选择而言，是一种效率低下的方法。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的电子烟供应组中，产品替代何时发生。
我们对120名患有严重精神疾病的吸烟者（2017 - 2020年招募）进行了二次分析，这些吸烟者被给予一次性电子烟8周，并在第0周（t0）、第2周、第4周、第6周和第8周进行评估。我们通过产品使用变化的逐次访视相关性来探索产品替代，然后建立了一个关于香烟和电子烟使用的双过程增长模型，以测试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。对于平均吸烟者（每天吸18支烟），每增加一次电子烟使用，t2时的吸烟频率就会降低0.39支（95%置信区间：-0.56 - -0.22）。存在效应修正（p = 0.033），即基线轻度吸烟者（每天<10支烟）在t2时吸烟频率没有显著下降，无论其最初电子烟使用量的增加情况如何，而重度吸烟者（每天38支烟）几乎是一对一地切换产品。
在本研究中，大多数产品替代发生在早期，且随着电子烟使用量的增加，重度吸烟者在t2时每天吸烟量的下降幅度更大。如果重复研究得到证实，这些发现可能表明为电子烟研究确立了一个新的结果——早期产品替代，并支持比较多种潜在危害较小的烟草产品的短期比较有效性试验的价值。
该研究在ClinicalTrials.gov官方网站上注册。
ID NCT03050853。
