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 尼古丁小袋代表了美国烟草市场的快速增长类别，但鲜为人知 关于它们的健康影响（包括增加）或对吸烟的影响。我们建议使用 随机对照试验方法，以告知FDA尼古丁袋对吸烟者的影响 有兴趣减少吸烟而不是吸烟。该提议的具体目的是招募 当前330名日常吸烟者的队列有兴趣减少吸烟，并衡量全面 基线时的行为和健康指标的电池电量，随机使用后16周以上 尼古丁袋中包含0mg，3mg或6mg尼古丁的尼古丁袋中的“光滑”或冬绿色的口味 随机双盲，安慰剂对照试验。该审判将在两个地点进行：宾夕法尼亚州赫尔希 以及德克萨斯州的M.D. Anderson，以招募潜水员的吸烟者样本。因此，该试验解决了 产品组成和设计的科学领域（特别是尼古丁含量和风味添加剂）。我们的 中心假设是毒性和健康效应的关键标志物（例如尿液Nnal，Exhaled CO，测量 香烟成瘾[例如FTND]，氧化应激和口服B（a）P DNA成瘾）将显着降低 在提供高尼古丁（6mg）尼古丁小袋的吸烟者中，相对于0mg袋。我们也会 评估尼古丁袋含量对尼古丁袋成瘾的影响以及小袋尼古丁的影响 香烟和其他烟草产品消费量。我们还将比较其中的效果 随机分配到“光滑”与冬绿色的风味。在16周的随机阶段之后，参与者将 鼓励戒烟并连接到电话停止服务，然后在四个星期后跟进 （第20周）为了确定小袋的尼古丁含量是否影响了意图和能力 戒烟。这项严格的双盲随机试验完成时，我们将有更好的 了解尼古丁小袋（及其尼古丁含量和风味特征）对 香烟消费量以及对健康风险，口腔健康和尼古丁成瘾的标志的变化。 我们还旨在证明此处使用的临床试验方法将来可以用来评估任何 新型烟草产物以相对标准化的方式。因此，该项目专门解决 （a）产品组成和设计的科学领域内的研究重点（b）毒性（c）健康 效果和（d）成瘾。