The abuse liability, topography and toxicology of ice flavors and non-menthol synthetic cooling agents in e-cigarette products

电子烟产品中冰香精和非薄荷醇合成清凉剂的滥用倾向、形貌和毒理学

基本信息

批准号：
10574136
负责人：
Alayna Pauline Tackett
金额：
$ 79.04万
依托单位：
OHIO STATE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-08-01 至 2028-07-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10574136
关键词：
Aerosols Anesthetics Behavior Behavioral Cicatrix Complex Cross-Over Trials Data Dermal Devices Diacetyl Disease Dose Electronic cigarette Epithelial Cells Esthesia Exposure to Eye Frequencies Fruit Genus Mentha Health Human Ice Ingestion Inhalation Lung Mainstreaming Mango - dietary Marketing Masks Measures Menthol Methods Names Nicotine Nicotine Dependence Participant Property Qualifying Randomized Regimen Research Personnel Rewards Safety Sensory Single-Blind Study Tobacco Toxic effect Toxicant exposure Toxicology Water Watermelon Weight Withdrawal Youth abuse liability addiction liability aged behavioral economics bronchial epithelium craving cytotoxicity e-cigarette aerosols electronic cigarette use electronic cigarette user electronic liquid evidence base exposed human population exposure pathway exposure route indexing novel psychologic satisfaction tobacco regulatory science toxicant uptake vaper vaping young adult

项目摘要

PROJECT SUMMARY Recently, synthetic cooling agents, WS-3 (N-ethyl-p-menthane-3-carboxamide) and WS-23 (2-isopropyl-N,2,3 trimethylbutyramide), that solely impart a cooling sensation without a mint flavor, have been detected in e- cigarettes (ECs) and are marketed with “ice” as part of the flavor name (e.g., “watermelon ice”). Unlike menthol, synthetic cooling agents can be added at very high concentrations (>5% by weight) to e-liquids allowing users to get extreme cooling/anesthetic properties during vaping, without menthol’s unappealing properties (e.g., eye- watering, harshness). Synthetic cooling agents have the potential to increase indirect and direct harm to EC users. The proposed study will be the first to systematically investigate the effects of synthetic cooling agents on the appeal, puffing behavior, and toxicity of vaping. We will use a single-blind randomized crossover trial with young adult vapers (N = 120, aged 21-29 years), precisely manipulated e-liquids, a well-characterized commercial EC device, validated psycho-behavioral measures, and a novel puff-playback method to estimate human exposures to HPHCs and other toxicants from vaping e-liquids with and without synthetic cooling agents (i.e., WS-3 and WS-23). Specifically, we aim to determine the impact of e-liquids with (mango ice, tobacco ice) and without (mango, tobacco) the presence of synthetic cooling agents on abuse liability (appeal, sensory effects, demand), EC puffing behavior (i.e., EC topography), and toxicant exposure (harmful and potential harmful constituents). Additionally, topography data collected for all participants for each of the conditions vaped will be averaged to produce four human-derived puffing regimens. Machine vaping will be conducted for each of the four e-liquids using the associated human-derived puffing regimens to determine the range of HPHCs and other toxicants in mainstream EC vapor. Findings would immediately inform the evidence base needed to inform FDA rulemaking surrounding the use of synthetic cooling agent additives in EC products.

项目概要最近，合成凉味剂WS-3（N-乙基-对薄荷烷-3-甲酰胺）和WS-23（2-异丙基-N,2,3）三甲基丁酰胺），仅赋予清凉感，没有薄荷味，已在电子产品中检测到香烟（EC）并以“冰”作为风味名称的一部分进行销售（例如“西瓜冰”）。合成清凉剂可以以非常高的浓度（按重量计 >5%）添加到电子液体中，使用户能够在吸电子烟时获得极端的冷却/麻醉特性，而没有薄荷醇那些不吸引人的特性（例如，眼睛- 浇水、粗糙度）可能会增加对 EC 的间接和直接危害。拟议的研究将是第一个系统研究合成冷却剂对用户的影响的研究。我们将使用单盲随机交叉试验来研究电子烟的吸引力、吸烟行为和毒性。年轻的成年电子烟用户（N = 120，年龄 21-29 岁），精确操控的电子烟油，一种特征鲜明的电子烟商业 EC 设备、经过验证的心理行为测量以及一种新颖的抽吸回放方法来估计人类因吸食含有或不含合成冷却剂的电子烟液而接触 HPHC 和其他有毒物质（即 WS-3 和 WS-23）具体来说，我们的目标是确定电子液体（芒果冰、烟草冰）的影响。和没有（芒果，烟草）合成清凉剂的存在滥用倾向（上诉，感官影响、需求）、EC 抽吸行为（即 EC 地形）和有毒物质暴露（有害的和潜在的）此外，还收集了所有参与者在每种条件下收集的地形数据将平均产生四种人类衍生的吸食方案。四种电子液体使用相关的人源抽吸方案来确定 HPHC 的范围和主流 EC 蒸气中的其他有毒物质的调查结果将立即告知所需的证据基础。 FDA 围绕 EC 产品中合成清凉剂添加剂的使用制定规则。