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.

项目概要/摘要：项目3 尼古丁袋是美国烟草市场上快速增长的类别，但人们知之甚少 他们的健康影响（包括成瘾）或吸烟的影响。我们建议使用 告知FDA吸烟者使用尼古丁袋的影响的随机对照试验方法 减少吸烟，但不戒烟。这项建议的具体目的是招聘一名 一个有兴趣减少吸烟的330名目前每天吸烟者的队列，并测量一个全面的 基线时和随机使用后16周内的行为和健康指标组合 尼古丁袋含有0毫克，3毫克或6毫克尼古丁的“光滑”或冬青口味， 随机双盲安慰剂对照试验。该试验将在两个地点进行：宾夕法尼亚州好时 和医学博士安德森在得克萨斯州，以招募不同的吸烟者样本。因此，本试验旨在解决 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 中心假设是毒性和健康影响的关键标志物（如尿液NNAL、呼出的CO、测量 吸烟成瘾[如FTND]、氧化应激和口服B（a）P DNA加合物）的发生率将显著降低 在提供高尼古丁（6 mg）尼古丁袋的吸烟者中，相对于0 mg袋。我们还将 评估尼古丁袋内容物对尼古丁袋成瘾的影响，以及袋尼古丁的影响 香烟和其他烟草制品消费的剂量。我们还将比较在那些 随机分为“光滑”和冬青口味。在16周的随机化阶段后，参与者将 鼓励戒烟并连接电话戒烟服务，然后在4周后进行随访 (week 20）为了确定小袋的尼古丁含量是否影响吸烟的意图和能力， 戒烟在这项严格的双盲随机试验完成后，我们将有一个更好的 了解尼古丁袋（及其尼古丁含量和风味特征）对 吸烟量以及由此产生的健康风险、口腔健康和尼古丁成瘾标志物的变化。 我们还旨在证明，在这里使用的临床试验方法可能在未来用于评估任何 以相对标准化的方式生产新型烟草产品。因此，本项目特别针对 （a）产品成分和设计（B）毒性（c）健康 （一）影响和（二）成瘾。