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

• 批准号: 10665898
• 负责人: JONATHAN FOULDS
• 金额: $ 99.69万
• 依托单位: PENNSYLVANIA STATE UNIV HERSHEY MED CTR
• 依托单位国家: 美国
• 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: https://reporter.nih.gov/project-details/10665898
• 关键词: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol; Address; Adverse event; Authorization documentation; Behavior; Behavioral; Benefits and Risks; Biological Markers; Blood Pressure; Carbon Monoxide; Categories; Characteristics; Cigarette; Clinical Trials; Collaborations; Consumption; Cotinine; DNA Adduction; DNA Adducts; DNA Damage; Data; Development; Doctor of Medicine; Dose; Double-Blind Method; Electronic cigarette; Exhalation; Exposure to; Fiber; Future; Genus Mentha; Health; Heart Rate; Infrastructure; Intention; Isoprostanes; Marketing; Measures; Methodology; Methods; Modeling; Monitor; Nicotine; Nicotine Dependence; Nitrosamines; Oral; Oral cavity; Oral health; Oxidative Stress; Participant; Phase; Placebo Control; Powder dose form; Public Health; Randomized; Randomized, Controlled Trials; Recommendation; Reporting; Research Personnel; Research Priority; Risk; Sales; Sampling; Services; Severities; Site; Smokeless Tobacco; Smoker; Smoking; Standardization; Telephone; Texas; Therapeutic; Tobacco; Tobacco Dependence; Tobacco use; Toxic effect; Toxicant exposure; Universities; Urine; Virginia; Woman; Work; addiction; authority; benzo(a)pyrene-DNA adduct; carcinogenicity; cigarette addiction; cigarette smoking; cohort; design; diaries; disorder risk; double-blind placebo controlled trial; follow-up; innovation; interest; nicotine use; novel; oral irritation; product development; pulmonary symptom; randomized placebo controlled trial; randomized trial; recruit; response; smoking cessation; standard measure; tobacco advertising; tobacco products; tobacco user; tobacco-free

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 尼古丁袋代表了美国烟草市场中一个快速增长的类别，但人们知之甚少 关于它们对健康的影响（包括成瘾）或对吸烟的影响。 随机对照试验方法，向 FDA 通报尼古丁袋使用对吸烟者的影响 对减少吸烟但不戒烟感兴趣的人 该提案的具体目的是招募一名吸烟者。 由 330 名目前每天吸烟且有兴趣减少吸烟的人组成的队列，并测量综合 基线时以及随机使用后 16 周内的一系列行为和健康指标 尼古丁袋装，含有 0 毫克、3 毫克或 6 毫克尼古丁，呈“顺滑”或冬青口味。 该试验将在两个地点进行：宾夕法尼亚州立大学好时分校。 和德克萨斯州的MD安德森为了招募不同的吸烟者样本，因此这项试验解决了这个问题。 产品成分和设计的科学领域（特别是尼古丁含量和风味添加剂）。 中心假设是毒性和健康影响的关键标志物（例如尿液 NNAL、呼出的 CO、测量 香烟成瘾 [例如 FTND]、氧化应激和口服 B(a)P DNA 加合物）将显着减少 对于接受高尼古丁 (6 毫克) 尼古丁袋的吸烟者，相对于 0 毫克尼古丁袋，我们也会这样做。 评估尼古丁袋含量对尼古丁袋成瘾的影响，以及袋尼古丁的影响 我们还将比较这些剂量对卷烟和其他烟草制品消费的影响。 在 16 周的随机阶段之后，参与者将被随机分为“平滑”口味和冬青口味。 鼓励戒烟并连接电话戒烟服务，然后在 4 周后进行随访 （第 20 周）为了确定烟袋中的尼古丁含量是否影响意图和能力 在完成这项严格的双盲随机试验后，我们将得到更好的戒烟结果。 了解尼古丁袋（及其尼古丁含量和风味特征）对人体的影响 卷烟消费以及由此导致的健康风险、口腔健康和尼古丁成瘾标志物的变化。 我们还旨在证明此处使用的临床试验方法将来可用于评估任何 因此，该项目专门针对以相对标准化的方式生产新型烟草产品。 (a) 产品成分和设计 (b) 毒性 (c) 健康科学领域内的研究重点 影响和 (d) 成瘾。