Behavioral Economics of Reduced-Nicotine Cigarettes: Interaction of Expectancy and Nicotine Dose Reduction

低尼古丁香烟的行为经济学：期望与尼古丁剂量减少的相互作用

• 批准号: 10272547
• 负责人: Justin Charles Strickland
• 金额: $ 12.28万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-01 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10272547
• 关键词: Address; Attention; Award; Behavioral; Behavioral Mechanisms; Behavioral Sciences; Blinded; Cigarette; Cigarette Smoker; Clinical Trials; Cognitive; Consumption; Data; Dose; Elasticity; Evaluation; Expectancy; Family Smoking Prevention and Tobacco Control Act; Future; Goals; Health Campaign; Health Policy; Human; Incentives; Individual; Knowledge; Label; Laboratories; Laboratory Study; Legal; Literature; Measures; Methods; Moods; Morbidity - disease rate; Nicotine; Nicotine Dependence; Outcome; Participant; Pharmaceutical Preparations; Pharmacodynamics; Pharmacologic Actions; Pharmacology; Placebo Effect; Play; Policies; Process; Public Health; Randomized; Reporting; Research; Research Design; Role; Smoke; Smoker; Smoking; Smoking Behavior; Tobacco; Toxicant exposure; Withdrawal; Woman; Work; authority; base; behavioral economics; cigarette smoking; combustible cigarette; cost; craving; expectation; experience; improved; low nicotine content cigarette; men; mortality; novel; response; smoking initiation; tobacco products; tobacco regulation; virtual

The 2009 Family Smoking Prevention and Tobacco Control Act gave the FDA authority to reduce public health harms of tobacco products. A key proposal is mandating nicotine reduction in cigarettes. It is hypothesized that reducing nicotine content will mitigate the overwhelming morbidity associated with smoking by decreasing smoking initiation and increasing cessation rates among established smokers. Clinical trials have provided promising support by demonstrating reductions in toxicant exposure and nicotine dependence for individuals randomized to reduced-nicotine cigarette conditions. Experimental work on reduced-nicotine cigarette pharmacodynamics has almost exclusively used blinded conditions, precluding systematic evaluation of how expectations about reduced-nicotine cigarettes may impact behavioral and subjective response. Given that real-world settings will involve unblinded products, information about expectancies is essential to inform how reduced-nicotine products will be perceived in future real-world markets. The proposed human laboratory study will systematically determine the independent and interactive effects of expectancy and nicotine dose on reinforcing (behavioral economic demand), subjective, and topography outcomes. Participants (10 men/women) in the proposed study will complete 4 experimental sessions in which expectancy (labeling of “average” nicotine versus “very low” nicotine) and nicotine dose (15.8 mg/g versus 0.4 mg/g) are manipulated as within-subject variables. Participants will smoke one study cigarette of these combinations at the start of each session and complete craving, mood, withdrawal, and subjective drug effect measures before and after smoking. Smoking topography will also be collected during cigarette administration to determine if expectancy and dose impact how one smokes – one way that cognitive or pharmacological effects can impact smoking behavior. Demand will be evaluated with an incentivized demand task using experienced outcomes to improve experimental rigor. Behavioral economic demand analyses will differentiate between effects attributable to consumption of a good at no or little cost (“demand intensity”) and consumption following increases in cost (“demand elasticity”). We hypothesize lower demand, subjective effects, and puff volume for “very low” labels and low nicotine dose cigarettes, with the lowest demand when in combination. This Behavioral Science Track Award for Rapid Transition (B/Start) R03 will provide critical information to the FDA on the reinforcing effects of smoking due to not only nicotine content, but nicotine expectancy – a factor that has received virtually no attention in nicotine reduction research. Identifying the specific behavioral mechanisms impacted by these factors is relevant as each have very different public health implications (e.g., impacts specific to demand intensity but not demand elasticity indicate that policy targeting cost changes would have minimal impact). These data will provide clear behavioral targets for subsequent research designed to optimize public health campaigns addressing nicotine-reduction policy.

2009年《家庭吸烟预防和烟草控制法》赋予FDA权力， 烟草制品的危害。一个关键的建议是强制减少香烟中的尼古丁。它是假设 降低尼古丁含量将通过减少吸烟引起的 吸烟的开始和戒烟率的增加。临床试验提供了 通过证明个人的毒物暴露和尼古丁依赖减少， 随机分配到尼古丁减少的香烟条件下。低烟碱卷烟的试验研究 药效学几乎完全使用盲态条件，排除了系统评价如何 对低尼古丁香烟的期望可能会影响行为和主观反应。鉴于 现实世界的环境将涉及揭盲产品，关于预期的信息对于告知如何 减少尼古丁的产品将在未来的现实市场中被感知。拟议的人体实验室研究 将系统地确定预期和尼古丁剂量对吸烟的独立和交互作用， 强化（行为经济需求）、主观和地形结果。参加者（10人） 男性/女性）将完成4个实验阶段，其中预期（标记为 “平均”尼古丁对“极低”尼古丁）和尼古丁剂量（15.8 mg/g对0.4 mg/g）进行操作 作为受试者内变量。受试者将在开始时吸烟这些组合中的一支研究香烟。 每一个会议和完整的渴望，情绪，戒断，和主观药物效果的措施之前和之后， smoking.在香烟给药期间还将收集吸烟地形图，以确定预期 以及剂量对吸烟方式的影响--认知或药理作用对吸烟的影响之一 行为将通过激励需求任务评估需求，并使用经验成果来改进 实验的严谨性行为经济需求分析将区分归因于以下因素的影响： 无成本或低成本消费（“需求密集度”）和成本增加后的消费 （“需求弹性”）。我们假设“非常低”标签的需求、主观影响和抽吸量较低 和低尼古丁剂量香烟，两者结合时需求量最低。行为科学路线 快速转换（B/Start）R 03奖将向FDA提供关于以下强化效果的关键信息： 吸烟不仅是因为尼古丁含量，而且是因为尼古丁预期--一个几乎没有受到任何影响的因素。 注意尼古丁减少研究。识别受这些影响的特定行为机制 因素是相关的，因为每个因素都具有非常不同的公共卫生影响（例如，具体针对需求的影响 强度而不是需求弹性表明，以成本变化为目标政策的影响最小）。 这些数据将为后续旨在优化公共卫生的研究提供明确的行为目标 针对尼古丁减少政策的运动。