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

• 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
• 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

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.

项目摘要 近年来，合成的清凉剂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），其仅赋予凉爽感而没有薄荷风味，已经在E- 香烟（EC）并以"冰"作为风味名称的一部分销售（例如，"西瓜冰"）。与薄荷醇不同， 合成冷却剂可以以非常高的浓度（> 5重量%）添加到电子液体中， 为了在吸电子烟期间获得极端的冷却/麻醉性质，而没有薄荷醇的不吸引人的性质（例如，眼睛- 浇水，苛刻）。合成冷却剂有可能增加对EC的间接和直接危害 用户.这项拟议的研究将是第一个系统地研究合成冷却剂对 电子烟的吸引力、吸烟行为和毒性。我们将使用单盲随机交叉试验， 年轻的成人vapers（N = 120，年龄21 - 29岁），精确操作的电子液体，一个良好的特征 商业EC设备，经验证的心理行为措施，以及一种新的吹气回放方法来估计 人类暴露于HPHC和其他有毒物质的电子烟液体，有和没有合成冷却剂 (i.e., WS-3和WS-23）。具体来说，我们的目标是确定电子液体与（芒果冰，烟草冰）的影响。 和没有（芒果，烟草）合成冷却剂的存在下对滥用倾向（上诉，感官 影响，需求），EC膨化行为（即，EC地形）和有毒物质暴露（有害和潜在 有害成分）。此外，为所有参与者收集的每种条件的地形数据都消失了。 将被平均以产生四种人源性膨化方案。机器vaping将进行每一个 四种电子液体使用相关的人源性抽吸方案来确定HPHC的范围， 其他有毒物质。调查结果将立即告知所需的证据基础， FDA围绕EC产品中合成冷却剂添加剂的使用制定规则。