Project 3: Randomized Placebo-controlled Trial of Nicotine Pouches in Smokers
项目 3:吸烟者尼古丁袋的随机安慰剂对照试验
基本信息
- 批准号:10665898
- 负责人:
- 金额:$ 99.69万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2023
- 资助国家:美国
- 起止时间:2023-09-30 至 2028-08-31
- 项目状态:未结题
- 来源:
- 关键词:4-(methylnitrosamino)-1-(3-pyridyl)-1-butanolAddressAdverse eventAuthorization documentationBehaviorBehavioralBenefits and RisksBiological MarkersBlood PressureCarbon MonoxideCategoriesCharacteristicsCigaretteClinical TrialsCollaborationsConsumptionCotinineDNA AdductionDNA AdductsDNA DamageDataDevelopmentDoctor of MedicineDoseDouble-Blind MethodElectronic cigaretteExhalationExposure toFiberFutureGenus MenthaHealthHeart RateInfrastructureIntentionIsoprostanesMarketingMeasuresMethodologyMethodsModelingMonitorNicotineNicotine DependenceNitrosaminesOralOral cavityOral healthOxidative StressParticipantPhasePlacebo ControlPowder dose formPublic HealthRandomizedRandomized, Controlled TrialsRecommendationReportingResearch PersonnelResearch PriorityRiskSalesSamplingServicesSeveritiesSiteSmokeless TobaccoSmokerSmokingStandardizationTelephoneTexasTherapeuticTobaccoTobacco DependenceTobacco useToxic effectToxicant exposureUniversitiesUrineVirginiaWomanWorkaddictionauthoritybenzo(a)pyrene-DNA adductcarcinogenicitycigarette addictioncigarette smokingcohortdesigndiariesdisorder riskdouble-blind placebo controlled trialfollow-upinnovationinterestnicotine usenoveloral irritationproduct developmentpulmonary symptomrandomized placebo controlled trialrandomized trialrecruitresponsesmoking cessationstandard measuretobacco advertisingtobacco productstobacco usertobacco-free
项目摘要
Project Summary/Abstract: Project 3
Nicotine Pouches represent a rapidly growing category in the U.S. tobacco market, but little is known
about their health effects (including addiction) or effects on cigarette smoking. We propose to use a
randomized controlled trial methodology to inform FDA on the effects of nicotine pouch use in smokers
interested in reducing their smoking but not quitting smoking. The specific aim of this proposal is to recruit a
cohort of 330 current daily smokers with an interest in reducing smoking, and to measure a comprehensive
battery of behavioral and health indicators at baseline, and over 16 weeks after being randomized to use
Nicotine Pouches containing either 0mg, 3mg or 6mg nicotine in “Smooth” or Wintergreen flavors in a
randomized double-blind, placebo-controlled trial. The trial will be conducted at two sites: Penn State Hershey
and M.D. Anderson in Texas in order to recruit a diverse sample of smokers. This trial therefore addresses the
scientific domain of Product Composition and Design (specifically nicotine content and flavor additives). Our
central hypothesis is that key markers of toxicity and health effects (e.g. urine NNAL, exhaled CO, measures
of cigarette addiction [e.g. FTND], oxidative stress and oral B(a)P DNA adducts) will be significantly reduced
in smokers who are provided high nicotine (6mg) Nicotine Pouches, relative to 0mg pouches. We will also
assess the effects of Nicotine Pouch content on Nicotine Pouch addiction, and the effects of pouch nicotine
dose on cigarette and other tobacco product consumption. We will also compare the effects in those
randomized to “Smooth” versus Wintergreen flavors. After the 16-week randomized phase, participants will be
encouraged to quit smoking and connected to telephone cessation services and then followed-up 4 weeks later
(week 20) in order to ascertain whether the nicotine content of the pouches influenced intention and ability to
quit smoking. At the completion of this rigorous double-blind randomized trial we will have a better
understanding of the effects of Nicotine Pouches (and their nicotine content and flavor characteristics) on
cigarette consumption and the resulting changes to markers of health risks, oral health and nicotine addiction.
We also aim to demonstrate that the clinical trial method used here may in future be used to evaluate any
novel tobacco product in a relatively standardized manner. As such, this project specifically addresses
research priorities within the scientific domains of (a) Product Composition and Design (b) Toxicity (c) Health
Effects and (d) Addiction.
项目摘要/摘要:项目3
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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JONATHAN FOULDS其他文献
JONATHAN FOULDS的其他文献
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{{ truncateString('JONATHAN FOULDS', 18)}}的其他基金
Penn State TCORS: Tobacco Product Composition Effects on Toxicity and Addiction
宾夕法尼亚州立大学 TCORS:烟草产品成分对毒性和成瘾性的影响
- 批准号:
10665895 - 财政年份:2023
- 资助金额:
$ 99.69万 - 项目类别:
Randomized trial of low nicotine cigarettes plus electronic cigarettes in smokers with a mental health condition
对有心理健康状况的吸烟者进行低尼古丁香烟加电子烟的随机试验
- 批准号:
10229461 - 财政年份:2019
- 资助金额:
$ 99.69万 - 项目类别:
Does Switching to Nicotine-containing Electronic Cigarettes Reduce Health Risk Markers?
改用含尼古丁的电子烟会减少健康风险标志吗?
- 批准号:
9752508 - 财政年份:2018
- 资助金额:
$ 99.69万 - 项目类别:
Does Switching to Nicotine-containing Electronic Cigarettes Reduce Health Risk Markers?
改用含尼古丁的电子烟会减少健康风险标志吗?
- 批准号:
10294089 - 财政年份:2018
- 资助金额:
$ 99.69万 - 项目类别:
Random nicotine delivery: A novel intervention for smokers
随机尼古丁输送:针对吸烟者的新型干预措施
- 批准号:
8809791 - 财政年份:2014
- 资助金额:
$ 99.69万 - 项目类别:
Random nicotine delivery: A novel intervention for smokers
随机尼古丁输送:针对吸烟者的新型干预措施
- 批准号:
8925844 - 财政年份:2014
- 资助金额:
$ 99.69万 - 项目类别:
Project 2: Reduced Nicotine Cigarettes in Smokers with Mood and Anxiety p248-288
项目 2:减少情绪和焦虑吸烟者的尼古丁香烟 p248-288
- 批准号:
8737840 - 财政年份:2014
- 资助金额:
$ 99.69万 - 项目类别:
Pennsylvania State University Tobacco Center of Regulatory Science (TCORS)
宾夕法尼亚州立大学烟草监管科学中心 (TCORS)
- 批准号:
8919320 - 财政年份:2013
- 资助金额:
$ 99.69万 - 项目类别:
Pennsylvania State University Tobacco Center of Regulatory Science (TCORS)
宾夕法尼亚州立大学烟草监管科学中心 (TCORS)
- 批准号:
8582174 - 财政年份:2013
- 资助金额:
$ 99.69万 - 项目类别:
Project 2: Reduced Nicotine Cigarettes in Smokers with Mood and Anxiety p248-288
项目 2:减少情绪和焦虑吸烟者的尼古丁香烟 p248-288
- 批准号:
8594387 - 财政年份:2013
- 资助金额:
$ 99.69万 - 项目类别:
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