Predicting Effects of ENDS Flavor Regulations on Tobacco Behavior, Toxicity, and Abuse Liability among African American Menthol Smokers
预测 ENDS 风味法规对非裔美国薄荷醇吸烟者烟草行为、毒性和滥用责任的影响
基本信息
- 批准号:10836137
- 负责人:
- 金额:$ 2.36万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2021
- 资助国家:美国
- 起止时间:2021-07-01 至 2024-06-30
- 项目状态:已结题
- 来源:
- 关键词:4-(methylnitrosamino)-1-(3-pyridyl)-1-butanolAddressAdultAffectAfrican AmericanAfrican American populationAirAsian populationBehaviorBiological MarkersBlack raceCarbon MonoxideCharacteristicsCigarCigaretteCigarette SmokerClinical TrialsCotinineDataData CollectionDevicesDisparityElectronic Nicotine Delivery SystemsElectronic cigaretteEquilibriumEquityEthnic OriginEthnic PopulationExposure toFutureGenerationsHealth BenefitHealth PromotionHispanic PopulationsIncidenceJUULMarketingMeasuresMentholMissionMonitorNicotineParticipantPatient Self-ReportPatternPropylene GlycolsPublic HealthRaceRandomizedRegulationReportingSamplingSensorySmokeSmokerSmokingSystemTestingTimeTobaccoTobacco useTobacco-Related CarcinomaToxic effectToxicant exposureUrineVisitWorkYouthabuse liabilityaccess restrictionsaddictionarmbehavioral economicscigarette smokingcostethnic minorityexperiencefollow-upinstrumentmortalityracial minorityracial populationresponsesensory systemsmoking cessationtobacco flavortobacco productsuptake
项目摘要
PROJECT SUMMARY. Black/African Americans (AA) have the highest tobacco-related cancer incidence and
mortality rates of any racial/ethnic group. Over 70% of AA smokers smoke menthol as their usual brand,
compared to 20% for White smokers. Menthol is the only characterizing flavor allowed in cigarettes under
current federal regulations, and menthol use is associated with progression to established cigarette smoking as
well as more difficulty quitting. Evidence regarding the effects of electronic nicotine delivery systems (ENDS,
i.e., e-cigarettes) suggests these products may be a less harmful alternative to cigarettes. Little work has
examined how ENDS uptake affects tobacco use and associated toxicity among AA smokers, particularly
those who smoke menthol. Recently, FDA began regulating closed-system devices like JUUL, which have
captured over 70% of the ENDS market and contributed to dramatic increases in youth ENDS use. As of early
2020, flavored ENDS cartridges (small, enclosed unit used as part of an ENDS) other than menthol/tobacco
are banned in the US. However, to achieve its public health mission, the FDA must balance restricting access
to ENDS flavors that appeal to youth with the need for evidence on “whether and how certain flavors may help
adult cigarette smokers reduce cigarette use and switch to potentially less harmful products” (FDA, 2018).
Understanding the potential of ENDS to reduce the public health burden of combusted tobacco use equitably
requires a targeted study to predict how future ENDS flavor regulations will impact AA menthol smokers.
The current study will evaluate whether ENDS menthol flavor availability affects measures of tobacco use,
biomarkers of cigarette/ENDS exposure, and addiction among AA menthol smokers (N=210) by performing a
3-arm, parallel-group, 6-week clinical trial of ENDS provision with follow-up to 30 days. JUUL devices with
compatible cartridges at 5% nicotine, which our team has extensively evaluated, will be provided. Study arms
will differ by potential FDA regulations on ENDS flavor availability: 1) the current market where only menthol
and tobacco flavored ENDS cartridges are available; 2) a market where only tobacco flavor is available, and 3)
a market with only unflavored cartridges. Study visits will occur weekly beginning 1 week prior to randomization
with daily tobacco use monitoring throughout and biomarker/self-report data collection at each weekly visit.
AA menthol smokers are disproportionately harmed by tobacco products and could experience significant
health benefits from increased availability of well-regulated ENDS. Results of this work will help FDA make
predictions about the impact on AA menthol smokers of moving from the current regulatory market for
cartridge-based ENDS where menthol and tobacco are available, to one where only tobacco or no flavors are
available. Answers to these questions will address FDA's priorities in behavior, toxicity, and addiction, and will
provide new data regarding the consequences of potential FDA regulatory actions on menthol flavor ENDS to
help maximize health-promoting effects and minimize unintended consequences among AA menthol smokers.
项目摘要。黑人/非裔美国人(AA)的烟草相关癌症发病率最高,
任何种族/族裔群体的死亡率。超过70%的AA吸烟者吸薄荷醇作为他们通常的品牌,
相比之下,白色吸烟者只有20%。薄荷味是唯一允许在香烟中使用的特征性香料,
目前的联邦法规,薄荷醇的使用与发展到既定的吸烟有关,
更难戒掉。关于电子尼古丁输送系统影响的证据(ENDS,
也就是说,电子烟)表明这些产品可能是香烟的危害较小的替代品。很少有人
研究了ENDS摄取如何影响AA吸烟者的烟草使用和相关毒性,特别是
抽薄荷烟的人最近,FDA开始监管像JUUL这样的封闭系统设备,
占据了70%以上的ENDS市场,并为青少年ENDS使用的急剧增加做出了贡献。作为早期
2020,除薄荷醇/烟草外的调味ENDS盒(用作ENDS一部分的小型封闭单元)
在美国被禁止。然而,为了实现其公共卫生使命,FDA必须平衡限制获取
结束口味,吸引年轻人的需要的证据“是否和如何某些口味可能有助于
成年吸烟者减少吸烟,转而使用潜在危害较小的产品”(FDA,2018)。
了解ENDS在公平减少燃烧烟草使用的公共卫生负担方面的潜力
需要有针对性的研究来预测未来的ENDS风味法规将如何影响AA薄荷醇吸烟者。
目前的研究将评估ENDS薄荷醇香料的可用性是否影响烟草使用的措施,
通过在AA薄荷醇吸烟者(N=210)中进行一项研究,
3组、平行组、为期6周的ENDS提供临床试验,随访至30天。JUUL器械,
我们的团队已经广泛评估了5%尼古丁的兼容墨盒。个研究组
将因FDA对ENDS风味可用性的潜在规定而不同:1)目前市场上只有薄荷醇
和烟草味ENDS盒是可用的; 2)只有烟草味是可用的市场,以及3)
一个只有无味墨盒的市场。从随机化前1周开始,每周进行一次研究访视
在整个过程中进行每日烟草使用监测,并在每次每周访视时收集生物标志物/自我报告数据。
AA薄荷醇吸烟者受到烟草产品的不成比例的伤害,
健康受益于监管良好的ENDS的增加。这项工作的结果将有助于FDA
关于从目前的监管市场转向对AA薄荷醇吸烟者的影响的预测,
从以薄荷为基础的ENDS,其中薄荷醇和烟草是可用的,到一个只有烟草或没有香料的地方,
available.这些问题的答案将涉及FDA在行为、毒性和成瘾方面的优先事项,
提供关于FDA对薄荷醇香料ENDS的潜在监管行动的后果的新数据,
有助于最大限度地提高健康促进作用,并最大限度地减少AA薄荷醇吸烟者的意外后果。
项目成果
期刊论文数量(1)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
Effects of Aftermarket Electronic Cigarette Pods on Device Power Output and Nicotine, Carbonyl, and ROS Emissions.
- DOI:10.1021/acs.chemrestox.3c00213
- 发表时间:2023-12-18
- 期刊:
- 影响因子:4.1
- 作者:Talih S;Karaoghlanian N;Salman R;Hilal E;Patev A;Bell A;Fallah S;El-Hage R;Saliba NA;Cobb C;Barnes A;Shihadeh A
- 通讯作者:Shihadeh A
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
数据更新时间:{{ journalArticles.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ monograph.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ sciAawards.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ conferencePapers.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ patent.updateTime }}
Andrew James Barnes其他文献
Andrew James Barnes的其他文献
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
{{ truncateString('Andrew James Barnes', 18)}}的其他基金
Improving quality and equity of opioid use disorder treatment using a multi-state Medicaid research network
利用多州医疗补助研究网络提高阿片类药物使用障碍治疗的质量和公平性
- 批准号:
10771064 - 财政年份:2023
- 资助金额:
$ 2.36万 - 项目类别:
Predicting Effects of ENDS Flavor Regulations Among Latinx/e Smokers: Impact of Cultural Assets on Attitudes, Intentions, and Behavior.
预测 ENDS 风味法规对拉丁裔/电子烟民的影响:文化资产对态度、意图和行为的影响。
- 批准号:
10727107 - 财政年份:2023
- 资助金额:
$ 2.36万 - 项目类别:
Predicting Effects of ENDS Flavor Regulations on Tobacco Behavior, Toxicity, and Abuse Liability among African American Menthol Smokers
预测 ENDS 风味法规对非裔美国薄荷醇吸烟者烟草行为、毒性和滥用责任的影响
- 批准号:
10427152 - 财政年份:2021
- 资助金额:
$ 2.36万 - 项目类别:
Predicting Effects of ENDS Flavor Regulations on Tobacco Behavior, Toxicity, and Abuse Liability among African American Menthol Smokers
预测 ENDS 风味法规对非裔美国薄荷醇吸烟者烟草行为、毒性和滥用责任的影响
- 批准号:
10652389 - 财政年份:2021
- 资助金额:
$ 2.36万 - 项目类别:
Effects of cigar flavors on measures of abuse liability among young adults
雪茄口味对年轻人滥用倾向的影响
- 批准号:
9350274 - 财政年份:2016
- 资助金额:
$ 2.36万 - 项目类别:
相似海外基金
Rational design of rapidly translatable, highly antigenic and novel recombinant immunogens to address deficiencies of current snakebite treatments
合理设计可快速翻译、高抗原性和新型重组免疫原,以解决当前蛇咬伤治疗的缺陷
- 批准号:
MR/S03398X/2 - 财政年份:2024
- 资助金额:
$ 2.36万 - 项目类别:
Fellowship
Re-thinking drug nanocrystals as highly loaded vectors to address key unmet therapeutic challenges
重新思考药物纳米晶体作为高负载载体以解决关键的未满足的治疗挑战
- 批准号:
EP/Y001486/1 - 财政年份:2024
- 资助金额:
$ 2.36万 - 项目类别:
Research Grant
CAREER: FEAST (Food Ecosystems And circularity for Sustainable Transformation) framework to address Hidden Hunger
职业:FEAST(食品生态系统和可持续转型循环)框架解决隐性饥饿
- 批准号:
2338423 - 财政年份:2024
- 资助金额:
$ 2.36万 - 项目类别:
Continuing Grant
Metrology to address ion suppression in multimodal mass spectrometry imaging with application in oncology
计量学解决多模态质谱成像中的离子抑制问题及其在肿瘤学中的应用
- 批准号:
MR/X03657X/1 - 财政年份:2024
- 资助金额:
$ 2.36万 - 项目类别:
Fellowship
CRII: SHF: A Novel Address Translation Architecture for Virtualized Clouds
CRII:SHF:一种用于虚拟化云的新型地址转换架构
- 批准号:
2348066 - 财政年份:2024
- 资助金额:
$ 2.36万 - 项目类别:
Standard Grant
The Abundance Project: Enhancing Cultural & Green Inclusion in Social Prescribing in Southwest London to Address Ethnic Inequalities in Mental Health
丰富项目:增强文化
- 批准号:
AH/Z505481/1 - 财政年份:2024
- 资助金额:
$ 2.36万 - 项目类别:
Research Grant
ERAMET - Ecosystem for rapid adoption of modelling and simulation METhods to address regulatory needs in the development of orphan and paediatric medicines
ERAMET - 快速采用建模和模拟方法的生态系统,以满足孤儿药和儿科药物开发中的监管需求
- 批准号:
10107647 - 财政年份:2024
- 资助金额:
$ 2.36万 - 项目类别:
EU-Funded
BIORETS: Convergence Research Experiences for Teachers in Synthetic and Systems Biology to Address Challenges in Food, Health, Energy, and Environment
BIORETS:合成和系统生物学教师的融合研究经验,以应对食品、健康、能源和环境方面的挑战
- 批准号:
2341402 - 财政年份:2024
- 资助金额:
$ 2.36万 - 项目类别:
Standard Grant
Ecosystem for rapid adoption of modelling and simulation METhods to address regulatory needs in the development of orphan and paediatric medicines
快速采用建模和模拟方法的生态系统,以满足孤儿药和儿科药物开发中的监管需求
- 批准号:
10106221 - 财政年份:2024
- 资助金额:
$ 2.36万 - 项目类别:
EU-Funded
Recite: Building Research by Communities to Address Inequities through Expression
背诵:社区开展研究,通过表达解决不平等问题
- 批准号:
AH/Z505341/1 - 财政年份:2024
- 资助金额:
$ 2.36万 - 项目类别:
Research Grant