未过滤香烟对吸烟行为和毒物暴露的影响：一项随机交叉临床试验方案
Effects of Unfiltered Cigarettes on Smoking Behavior and Toxicant Exposure: Protocol for a Randomized Crossover Clinical Trial.
作者信息
Oren Eyal, Pulvers Kim, Romero Devan R, Barber Casey, Carter Erika, Tracy Laree A, Novotny Thomas E
机构信息
Division of Epidemiology and Biostatistics, School of Public Health, San Diego State University, San Diego, CA, United States.
Department of Psychology, California State University San Marcos, San Marcos, CA, United States.
出版信息
JMIR Res Protoc. 2020 Dec 8;9(12):e19603. doi: 10.2196/19603.
BACKGROUND
Plastic filters on cigarette butts are a widespread source of nonbiodegradable, toxic environmental waste. State and local legislation to ban the sale of single-use cigarettes may be considered to prevent this waste, but scientific evidence on the impact of switching smokers to unfiltered cigarettes on smoking behavior and toxicant exposures is needed to inform this policy. We have designed an open-label, randomized, 9-week, crossover clinical trial of adult filtered-cigarette smokers who switch to unfiltered cigarettes.
OBJECTIVE
Our objective is to understand the impact of switching smokers of filtered cigarettes to unfiltered cigarettes on smoking behavior and toxic exposures.
METHODS
This trial involves a 1-week baseline period; a 2-week period of smoking filtered or unfiltered cigarettes, where groups are randomly assigned; a 3-week washout period; another 1-week baseline period; and a 2-week crossover period of smoking the opposite condition (ie, filtered or unfiltered cigarettes) for a sufficient sample size of 40 participants. We will determine changes in (1) observed topography (ie, puff count, interpuff interval, and puff volume) and cigarettes smoked per day, via butt counts and self-report, (2) expired carbon monoxide and excretion of urinary cotinine, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol, and volatile organic compounds, and (3) participants' knowledge and attitudes toward unfiltered cigarettes, satisfaction with smoking, and intention to quit if they were not able to smoke filtered cigarettes.
RESULTS
This study was funded in June 2018 and approved by the relevant Institutional Review Boards in July 2018. This study has enrolled 37 participants as of October 2020. Data analysis is currently underway, and trial results are expected to be published in spring 2021.
CONCLUSIONS
This pilot proof-of-principle study will inform the design of a larger, future research project that can provide robust scientific evidence on our research question. Such a large study could inform possible state or local legislation to ban the sale of single-use filtered cigarettes in order to mitigate the environmental impact of discarded single-use plastic filters.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03749876; https://clinicaltrials.gov/ct2/show/NCT03749876.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/19603.
背景
烟蒂上的塑料过滤嘴是不可生物降解的有毒环境废物的广泛来源。可以考虑出台州和地方法规禁止销售一次性香烟以防止此类废物产生，但需要有关于吸烟者改吸无过滤嘴香烟对吸烟行为和接触有毒物质影响的科学证据，以便为这项政策提供依据。我们设计了一项针对成年过滤嘴香烟吸烟者改吸无过滤嘴香烟的开放标签、随机、为期9周的交叉临床试验。
目的
我们的目的是了解过滤嘴香烟吸烟者改吸无过滤嘴香烟对吸烟行为和有毒物质接触的影响。
方法
本试验包括1周的基线期；为期2周的吸过滤嘴或无过滤嘴香烟阶段，在此期间将参与者随机分组；3周的洗脱期；另一个1周的基线期；以及为期2周的交叉阶段，吸相反情况的香烟（即过滤嘴或无过滤嘴香烟），样本量为40名参与者，以确保有足够的样本量。我们将确定以下方面的变化：（1）通过烟蒂计数和自我报告确定观察到的吸烟形态（即抽吸次数、抽吸间隔和抽吸量）以及每天吸烟的支数；（2）呼出一氧化碳以及尿中可替宁、4-（甲基亚硝胺基）-1-（3-吡啶基）-1-丁醇和挥发性有机化合物的排泄情况；（3）参与者对无过滤嘴香烟的了解和态度、对吸烟的满意度以及如果无法吸过滤嘴香烟时的戒烟意愿。
结果
本研究于2018年6月获得资助，并于2018年7月获得相关机构审查委员会的批准。截至2020年10月，本研究已招募37名参与者。目前正在进行数据分析，试验结果预计于2021年春季发表。
结论
这项初步的原理验证研究将为未来一项更大的研究项目的设计提供信息，该项目能够就我们的研究问题提供有力的科学证据。这样一项大型研究可以为可能出台的州或地方法规提供依据，以禁止销售一次性过滤嘴香烟，从而减轻废弃一次性塑料过滤嘴对环境的影响。
试验注册
ClinicalTrials.gov NCT03749876；https://clinicaltrials.gov/ct2/show/NCT03749876。
国际注册报告识别码（IRRID）：DERR1-10.2196/19603。
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