Abuse liability assessment and characterization of an electronic nicotine deliver

描述（由申请人提供）：电子尼古丁输送系统（ENDS），通常称为电子香烟，在不允许吸烟的地方作为香烟的替代品推广，但也作为戒烟辅助手段。世界卫生组织烟草产品法规研究小组（TobReg）建议对ENDS进行严格的研究，以确定它们是否具有作为戒烟设备的任何优势。然而，在进行完整的临床试验之前，需要评估这些器械的滥用倾向，以及更好地描述产品的特征，并对推荐的给药方案提出一些想法。这是一项有三个目的的研究：1）在有戒烟动机的参与者样本中确定ENDS的滥用倾向潜力。滥用倾向评估（ALA）将包括与自有品牌商业香烟（具有已知滥用可能性的阳性对照）、ENDS安慰剂（仅感觉运动效应）和假吸烟（阴性对照）相比的主观喜好和渴望/戒断的缓解，在随意“吸烟”时ENDS的自我给药模式，以及停止使用后的戒断症状。ALA还将包括比较每种吸烟条件下的神经认知功能（EEG频谱分析和诱发脑电位）; 2）通过测量血浆尼古丁升高和ENDS喷烟地形图更好地表征ENDS; 3）为了告知未来的戒烟试验，确定戒烟尝试期间的随意使用模式。目标2和3还将有助于为未来的戒烟试验提供功效和样本量估计的效应量和变异性估计。14名已确定的吸烟者，未接受过ENDS治疗，有戒烟动机，戒烟12小时，将进行4次实验室访视，以比较吸烟ENDS 16 mg、ENDS安慰剂、自有品牌商业香烟和假吸烟，同时记录EEG并执行古怪任务。然后，他们将只使用ENDS两周，并进行四次戒烟行为咨询。在最后一次访视时，受试者将禁欲12小时，并返回实验室以评估ENDS的渴望/戒断，吸烟ENDS，抽血用于尼古丁增强和记录“吸烟”地形图。

DESCRIPTION (provided by applicant): Electronic nicotine delivery systems (ENDS), popularly known as electronic cigarettes, are promoted as substitutes for cigarettes in places where smoking is not allowed, but also as smoking cessation aids. The World Health Organization Study Group on Tobacco Product Regulation (TobReg) recommended ENDS be subjected to rigorous study to determine if they would have any advantage as a cessation device. Prior to a full clinical trial, however, an assessment of the abuse liability of these devices is required, as is better characterization of the products, and some idea of a recommended dosing schedule. This is a study with three aims: 1) to determine the abuse liability potential of ENDS in a sample of participants motivated to quit smoking. Abuse liability assessment (ALA) will include subjective liking and relief of craving/withdrawal in comparison to own brand commercial cigarette (positive control with known abuse potential), ENDS placebo (sensorimotor effects only), and sham smoking (negative control), self-administration pattern of ENDS while ad lib "smoking," and withdrawal symptoms upon discontinuation of use. ALA will also include comparing neurocognitive function (EEG spectral analysis and evoked brain potentials) during each smoking condition; 2) to better characterize ENDS by measuring plasma nicotine boost and ENDS puff topography; 3) in order to inform future cessation trials, determine patterns of ad lib use during a cessation attempt. Aims 2 and 3 will also help to provide estimates of effect size and variability for power and sample size estimates for a future cessation trial. Fourteen established cigarette smokers, naive to ENDS, motivated to quit smoking, and 12-hour abstinent, will have four laboratory visits to compare smoking ENDS 16mg, ENDS placebo, own brand commercial cigarettes and sham smoking while EEG is recorded and oddball tasks performed. They will then use ENDS exclusively for two weeks, with four sessions of smoking cessation behavioral counseling. On a final visit, participants will be 12-hours abstinent and return to the laboratory to assess craving/withdrawal from ENDS, smoke ENDS with blood drawn for nicotine boost and recording of "smoking" topography.