Evaluation of the Electronic Cigarette Withdrawal Syndrome: Mechanistic Targets for Intervention

项目摘要 电子烟是当今公共卫生领域最重要的问题之一。虽然e- 香烟已经显示出作为传统香烟的戒烟辅助物的前景，这些香烟的公共健康益处 产品可能会受到先前尼古丁初治青年中开始使用率飙升的影响， 这些产品的倾向，以促进尼古丁依赖。越来越多的人报告说 想要戒烟但无法成功戒烟，这强调了研究的必要性。 以确定阻碍电子烟戒烟的因素。当吸烟者突然戒除可燃物时， 吸烟，出现戒断综合征，包括负面影响和渴望的核心症状， 认知功能受损和睡眠紊乱，所有这些最终都会阻碍戒烟尝试。然而，在这方面， 关于电子烟戒断的对照研究非常有限，目前还不清楚尼古丁在多大程度上 导致任何紧急的电子烟戒断综合征。该项目将采用严格的住宅 实验室设计，以评估电子烟戒断表达并通过实验确定尼古丁的作用 在这个综合症。仅使用电子烟的健康成年人（N = 120）将接受监测的电子烟 在住宅单位禁欲超过7天（1周）。我们将评估尼古丁对 通过将参与者分配到三种条件之一：活性尼古丁贴片，安慰剂贴片 控制，或没有贴片来控制预期。相关的标准化行为和生物测量 将在整个过程中收集退出的患者报告、认知任务表现和生物特征 建立一个严格的戒断时间进程，并评估尼古丁对这些症状的影响。 三个特定目标旨在测试尼古丁戒断的核心特征，反映了以下三个核心领域： DSM-5中描述的尼古丁/烟草戒断。具体目标将评估时间进程和贡献 尼古丁对戒断引起的主观情绪（具体目标1）、认知能力（具体目标2） 目标2）和睡眠障碍（具体目标3）。探索性目标将评估退出对 动机和回报。我们假设负面影响和渴望会增加，认知表现， 睡眠时间会减少，在住宅禁欲期间睡眠会受损。我们还假设， 相对于两种对照条件，尼古丁贴片可减轻戒断症状。这项研究将 使用严格对照的居民研究，提供有关以下临床意义的重要信息： 行为和生物电子烟戒断症状，并证明尼古丁在表达中的作用 撤回通知翻译的可行性建立和容易获得的尼古丁替代品 对电子烟戒烟的干预。

PROJECT SUMMARY ABSTRACT Electronic cigarettes (e-cigarettes) are among the most important issues in public health today. Although e- cigarettes have shown promise as a cessation aid for traditional cigarettes, the public health benefits of these products may be undermined by the soaring rates of initiation among previously nicotine-naïve youth and the propensity for these products to foster nicotine dependence. There are a growing number of people who report wanting to quit using e-cigarettes and not being able to do so successfully, underscoring the need for research to determine factors that impede e-cigarette cessation. When smokers abstain abruptly from combustible cigarette use, a withdrawal syndrome emerges that includes core symptoms of negative affect and craving, impaired cognitive functioning, and disturbed sleep, all of which ultimately hinder cessation attempts. However, there is very limited controlled research on e-cigarette withdrawal, and it is unknown the extent to which nicotine contributes to any emergent e-cigarette withdrawal syndrome. This project will use a rigorous residential laboratory design to evaluate e-cigarette withdrawal expression and experimentally determine the role of nicotine in this syndrome. Healthy adults who exclusively use e-cigarettes (N=120) will undergo monitored e-cigarette abstinence over seven days (1 week) in a residential unit. We will evaluate the contribution of nicotine to withdrawal expression by assigning participants to one of three conditions: active nicotine patch, placebo patch control, or no patch to control for expectancies. Standardized behavioral and biological measures associated with withdrawal including patient report, cognitive task performance, and biometrics will be collected throughout to establish a rigorous timecourse of withdrawal and evaluate the contribution of nicotine to these symptoms. Three Specific Aims are designed to test core features of nicotine withdrawal mirroring three core areas of nicotine/tobacco withdrawal described in the DSM-5. Specific Aims will evaluate the timecourse and contribution of nicotine to withdrawal-induced changes in subjective mood (Specific Aim 1), cognitive performance (Specific Aim 2), and sleep disturbance (Specific Aim 3). An Exploratory Aim will evaluate the impact of withdrawal on motivation and return to use. We hypothesize negative affect and craving will increase, cognitive performance will decrease, and sleep will be impaired during the residential abstinence period. We also hypothesize that withdrawal symptoms will be attenuated with nicotine patch relative to both control conditions. This research will use a rigorously-controlled residential study to provide vital information about the clinical significance of behavioral and biological e-cigarette withdrawal symptoms and demonstrate the role of nicotine in the expression of withdrawal to inform the viability of translating established and readily accessible nicotine replacement interventions to e-cigarette cessation.