A controlled evaluation of abstinence-induced withdrawal and motivation to vape/smoke among daily ENDS users vs. cigarette smokers

对日常 ENDS 使用者与吸烟者的戒断引起的戒断和吸电子烟/吸烟动机的对照评估

• 批准号: 10428192
• 负责人: LARRY W HAWK
• 金额: $ 72.43万
• 依托单位: STATE UNIVERSITY OF NEW YORK AT BUFFALO
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-06-15 至 2027-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10428192
• 关键词: Abstinence; Acute; Address; Adult; Affect; Agitation; Anhedonia; Attenuated; Automobile Driving; Behavioral; Cause of Death; Cigarette; Cigarette Smoker; Complement; Dependence; Desire for food; Diagnosis; Electronic Nicotine Delivery Systems; Electronic cigarette; Equilibrium; Evaluation; Expectancy; Generations; Harm Reduction; Hour; Impact evaluation; Individual Differences; Intervention; Investigational Therapies; JUUL; Knowledge; Laboratories; Laboratory Study; Literature; Measures; Mediating; Mediator of activation protein; Metabolism; Methods; Modeling; Motivation; Nature; Nicotine; Nicotine Dependence; Nicotine Withdrawal; Outcome; Participant; Patient Self-Report; Persons; PhenX Toolkit; Public Health; Publishing; Questionnaires; Randomized; Relapse; Research; Research Priority; Role; Salts; Sample Size; Sampling; Science; Sensory; Sleep; Sleep Disorders; Smoke; Smoker; Smoking; Subgroup; Testing; Tobacco; Tobacco Control Research; Tobacco Dependence; Visit; Withdrawal; Withdrawal Symptom; Work; abuse liability; behavioral pharmacology; cigarette smoking; combustible cigarette; craving; experimental study; former smoker; increased appetite; negative affect; nicotine exposure; nicotine use; prospective; sex; smoking abstinence; smoking cessation; theories; therapy development; vaper; vaping

PROJECT SUMMARY/ABSTRACT Withdrawal is a key, multi-faceted component of tobacco/nicotine dependence. Because withdrawal symptoms are theorized to drive relapse, facets of withdrawal (e.g., craving, negative affect) are the targets of most current and emerging treatments. Despite the central importance of withdrawal, and a voluminous literature on withdrawal from combustible cigarette smoking, we know little about withdrawal from electronic nicotine delivery systems (ENDS). To overcome critical barriers to progress in the field, we propose the first-ever prospective, controlled comparison of abstinence- induced withdrawal between ENDS vapers and cigarette smokers. Participants will be 160 established daily vapers (including former smokers and dual users who smoke occasionally), 160 established daily smokers (including former vapers and dual users who vape occasionally), and (for exploratory comparisons) 50 established daily dual users, who smoke and vape daily. Participants will complete two 4-hour lab visits; the order of the ad lib use visit and the abstinent visit (which follows 24 hours of abstinence) will be randomized across participants. To advance knowledge of ENDS withdrawal, we will employ state-of-the-science, multi-measure, multi-method assessments of key withdrawal facets: negative affect, craving, difficulty concentrating, restlessness, sleep, and appetite, as well as anhedonia/positive affect and somatic effects. We hypothesize that, for each facet, withdrawal magnitude will be lower among vapers compared to smokers. To inform theory and intervention development, we will also evaluate the behavioral significance of ENDS withdrawal, testing the hypotheses that abstinence will increase the motivation to vape/smoke and this group difference will be accounted for (mediated) by vaper/smoker differences in one or more withdrawal facets. Exploratory analyses will examine whether group differences in withdrawal are accounted for (mediate) by differential nicotine exposure, explore the role of individual differences (e.g., sex, rate of nicotine metabolism, expectancies), and examine differences among sub-groups of vapers. The impact of this much-needed, detailed characterization of withdrawal from ENDS is enhanced by the inclusion of a comparator of great public health significance, cigarette smoking. In addition, by characterizing the specific withdrawal facets that drive motivation to vape/smoke, the proposed work will identify promising intervention targets for subsequent treatment development efforts.

项目概要/摘要 戒断是烟草/尼古丁依赖的一个关键的、多方面的组成部分。因为提款 理论上，症状会导致复发，戒断的各个方面（例如渴望、负面情绪）是 大多数当前和新兴治疗的目标。尽管撤军至关重要，而且 关于戒除可燃香烟的大量文献，我们知之甚少 从电子尼古丁传送系统（ENDS）中戒断。克服关键障碍 在该领域的进展中，我们提出了有史以来第一次对禁欲的前瞻性、受控比较 诱导 ENDS 电子烟使用者和吸烟者之间的戒断。参与者人数将达到160人 每日电子烟使用者（包括前吸烟者和偶尔吸烟的双重使用者），已建立 160 名 每日吸烟者（包括以前的电子烟使用者和偶尔使用电子烟的双重用户），以及（用于探索性 比较）50 名既定的每日双用户，每天吸烟和吸电子烟。参与者将完成 两次 4 小时的实验室参观；即兴使用访问和禁欲访问的顺序（在 24 小时后） 禁欲）将在参与者中随机分配。为了增进对 ENDS 撤回的了解，我们 将采用最先进的、多措施、多方法的关键提款方面评估： 负面情绪、渴望、难以集中注意力、烦躁、睡眠和食欲，以及 快感缺失/积极情感和躯体效应。我们假设，对于每个方面，退出 与吸烟者相比，电子烟使用者的程度会更低。为理论和干预提供信息 开发过程中，我们还将评估 ENDS 戒断的行为意义，测试 假设禁欲会增加电子烟/吸烟的动机，而这种群体差异将 可以通过电子烟使用者/吸烟者在一个或多个戒断方面的差异来解释（介导）。 探索性分析将检查是否考虑了戒断的群体差异 （中介）通过不同的尼古丁暴露量，探索个体差异的作用（例如性别、吸烟率） 尼古丁代谢、预期），并检查电子烟使用者亚组之间的差异。影响 纳入这一迫切需要的、详细的退出电子尼古丁传送系统的特征，得到了加强 吸烟是一个具有重大公共健康意义的比较对象。此外，通过表征 拟议的工作将确定推动电子烟/吸烟动机的具体戒断方面 后续治疗开发工作有希望的干预目标。