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

电子烟戒断综合症的评估：干预的机制目标

• 批准号: 10799725
• 负责人: Tory Richard Spindle
• 金额: $ 75.73万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 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/10799725
• 关键词: Abstinence; Acute; Adult; Area; Attenuated; Behavior assessment; Behavioral; Biological; Biometry; Cigarette; Clinical; Cognitive; DSM-V; Data; Dependence; Electroencephalography; Electronic cigarette; Enrollment; Evaluation; Expectancy; Fostering; Goals; Health Benefit; Health Policy; Hour; Impaired cognition; Impairment; Intervention; Laboratories; Measures; Monitor; Moods; Motivation; Nature; Nicotine; Nicotine Dependence; Nicotine Withdrawal; Outcome; Participant; Patients; Persons; Pharmacology; Placebos; Public Health; Regulation; Reporting; Research; Rewards; Role; Short-Term Memory; Sleep; Sleep Architecture; Sleep disturbances; Smoke; Smoker; Smoking Cessation Intervention; Standardization; Substance Withdrawal Syndrome; Symptoms; Syndrome; Task Performances; Testing; Tobacco; Tobacco use; Translating; Withdrawal; Withdrawal Symptom; Wrist; Youth; actigraphy; cigarette smoke; cigarette smoking; clinically significant; cognitive function; cognitive performance; cognitive task; combustible cigarette; craving; design; e-cigarette cessation; efficacy evaluation; electronic cigarette use; electronic cigarette user; experience; follow-up; health organization; insight; interest; negative affect; nicotine patch; nicotine replacement; pharmacologic; prolonged abstinence; return to use; sleep quality; smoking cessation; standardize measure; sustained attention; therapy development; vaping; virtual

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.

项目概要摘要 电子烟（e-香烟）是当今公共卫生中最重要的问题之一。 卷烟已显示出作为传统卷烟的戒烟辅助剂的前景，这些卷烟对公共健康的益处 产品可能会因以前从未接触过尼古丁的青少年和年轻人中开始使用尼古丁的比率飙升而受到损害。 越来越多的人报告称这些产品有助长尼古丁依赖的倾向。 想要戒掉电子烟但未能成功，强调了研究的必要性 确定吸烟者突然戒烟时阻碍电子烟戒烟的因素。 使用香烟，出现戒断综合症，包括负面影响和渴望的核心症状， 认知功能受损和睡眠不安，所有这些最终都会阻碍戒烟尝试。 关于电子烟戒断的对照研究非常有限，并且尚不清楚尼古丁的作用程度 该项目将采用严谨的住宅 评估电子烟戒断表达并通过实验确定尼古丁作用的实验室设计 专门使用电子烟的健康成年人（N=120）将接受电子烟监测。 在住宅单位戒烟超过 7 天（1 周），我们将评估尼古丁对人体的贡献。 通过指定以下三个条件之一来表示戒断表达：活性尼古丁贴片、安慰剂贴片 控制，或没有补丁来控制相关的标准化行为和生物测量。 退出期间将收集患者报告、认知任务表现和生物识别信息 建立严格的戒断时间并评估尼古丁对这些症状的影响。 三个具体目标旨在测试尼古丁戒断的核心特征，反映了尼古丁戒断的三个核心领域 DSM-5 中描述的尼古丁/烟草戒断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）、认知表现（具体 目标 2）和睡眠障碍（具体目标 3）将评估戒断对睡眠的影响。 我们勇敢地面对负面影响，渴望会增加，认知表现也会增加。 会减少，并且在居住禁欲期间睡眠会受到损害。 相对于两种对照条件，尼古丁贴片会减轻戒断症状。 使用严格控制的住院研究来提供有关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 退出以告知翻译已建立且易于获得的尼古丁替代品的可行性 戒烟干预措施。