Project 3

项目3

基本信息

批准号：
10664808
负责人：
Alayna Pauline Tackett
金额：
$ 56.66万
依托单位：
UNIVERSITY OF SOUTHERN CALIFORNIA
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-09-19 至 2028-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10664808
关键词：
Address Adolescent Affinity Age Area Behavior Behavioral Categories Data Data Analyses Dose Electronic cigarette Equity Evaluation Flavoring Fruit Genus Mentha Health Heterosexuals Intake Intention Marketing Masks Measures Menthol Modeling Motivation Nicotine Nicotine Dependence Oral Oral Characters Oral Examination Oral cavity Participant Pattern Persons Pharmaceutical Preparations Predisposition Randomized Regulation Rewards Sampling Science Self Administration Sensory Sexual and Gender Minorities Standardization Surveys Testing Tobacco Tobacco use Visit Vulnerable Populations Withdrawal Work absorption abuse liability addiction aged behavioral economics career cisgender computerized data processing design electronic cigarette use electronic cigarette user experience follow-up gender minority group improved indexing interest irritation nicotine gum nicotine use novel oral irritation prevent recruit residence vaper vaping virtual virtual laboratory willingness young adult

项目摘要

PROJECT SUMMARY: PROJECT 3 (P3) P3 examines which features of ONPs increase abuse liability and product appeal in young adult vapers. To accomplish this, P3 will use virtual (Zoom) visits to recruit a nationwide sample of 320 current e-cigarette users aged 21-25 years who are not planning to quit vaping and open to trying ONPs. We will conduct product appeal and abuse liability tests in a mixed factorial design varying ONPs by product type (nicotine pouch v. nonmedicinal gum) × Flavor (mint v. fruit) × Nicotine Concentration (4mg v. 2mg). Aim 1 is to assess the sensory appeal Hypotheses: 1a) Based on preliminary data, we predict greater appeal (e.g., willingness to use again) and desirable sensory attributes for gum vs. pouches and low vs. high nicotine. Given that mint masks nicotine’s bitterness and irritating effects, we hypothesize:1b) Mint will suppress the sensory appeal-reducing (and irritation-enhancing) effects of high vs. low nicotine (nicotine × flavor interaction). Aim 2 is to characterize ONP abuse liability. Using the highest rated mint and fruit ONPs from the previous appeal session, abuse liability for both flavors will be measured after 30-min standardized ONP self-administration via: i) positive subjective drug effects, withdrawal/urge relief, behavioral economic indices of ONP reward value, and novel dual use liability measures (i.e., motivation to use the ONP when e-cigarette use is constrained), and ii) naturalistic use after provision of study ONP in 1-week follow-up. Hypotheses: 2a) subjective drug effects, withdrawal/urge relief, ONP reward value, indices of demand, and naturalistic self-administration will be greater for high vs. low nicotine; 2b) ONP reward value, indices of demand, and naturalistic self-administration will be higher for gum (vs. pouch) 2c) ONP reward value, indices of demand, and naturalistic self-administration will be higher for mint than fruit, especially in the high nicotine condition (nicotine × flavor interaction). Aim 3 is to examine ONP appeal and abuse liability among sexual/gender minority (relative to majority) participants. We will include 20% (n = 64) self- identified SGM participants. Hypotheses: 3a) Given prior work, we predict that subjective and behavioral indices of appeal and abuse liability will be higher in SGM vs. heterosexual/cisgendered participants. Although we have no hypothesis that SGM will moderate the influence of flavor, nicotine concentration or ONP type, this possibility will be explored in regression models. Implications for regulation: If certain combinations of ONP types, flavors, and nicotine concentrations improve the user experience and enhance abuse liability, these products could encourage new e-cigarette+ONP dual use patterns (e.g., use ONPs at times when vaping is not possible). This could provide the FDA with evidence that denying marketing applications or prioritizing enforcement of illegal marketing for these specific ONPs could prevent AYAs who try ONPs from becoming persistent users with detrimental use patterns. FDA Scientific Areas: Behavior and Addiction.

项目摘要：项目 3 (P3) P3 研究了 ONP 的哪些功能会增加年轻成人电子烟使用者的滥用倾向和产品吸引力。为了实现这一目标，P3 将使用虚拟 (Zoom) 访问来招募全国范围内 320 名当前电子烟用户的样本年龄在 21-25 岁，不打算戒烟并愿意尝试 ONP 的人我们将进行产品申诉。和滥用责任测试，采用混合因子设计，按产品类型改变 ONP（尼古丁袋 v. 口香糖） × 风味（薄荷 vs. 水果） × 尼古丁浓度（4mg vs. 2mg）目标 1 是评估感官吸引力。假设： 1a) 根据初步数据，我们预测会有更大的吸引力（例如，愿意再次使用）并且鉴于薄荷掩盖了尼古丁，口香糖与袋装以及低尼古丁与高尼古丁的理想感官特性。苦味和刺激性的影响，我们勇敢面对：1b）薄荷会抑制感官吸引力，降低（和高尼古丁与低尼古丁的刺激增强效应（尼古丁 × 风味相互作用）目标 2 是描述 ONP 的特征。滥用责任。使用上一次上诉会议中评分最高的薄荷和水果 ONP，滥用责任。两种口味将在 30 分钟标准化 ONP 自我给药后通过以下方式进行测量： i) 阳性主观药物效果、撤回/迫切缓解、ONP 奖励价值的行为经济指数以及新颖的双重用途责任措施（即电子烟使用受到限制时使用 ONP 的动机），以及 ii) 之后的自然使用在 1 周随访中提供研究 ONP 假设：2a) 主观药物效应、戒断/冲动缓解、ONP。高尼古丁与低尼古丁相比，奖励价值、需求指数和自然自我管理会更大 2b) 口香糖（与袋装相比）的 ONP 奖励值、需求指数和自然自我管理将会更高 2c) 薄荷的 ONP 奖励值、需求指数和自然自我管理将高于水果，特别是在高尼古丁条件下（尼古丁 × 风味相互作用），目标 3 是检查 ONP 的吸引力和效果。性/性别少数（相对于多数）参与者的虐待倾向我们将包括 20% (n = 64) 的自我虐待者。确定的 SGM 参与者假设： 3a) 根据之前的工作，我们预测主观和行为指数与异性恋/顺性别参与者相比，SGM 的上诉和虐待责任会更高，尽管我们有。没有假设 SGM 会缓和风味、尼古丁浓度或 ONP 类型的影响，这种可能性将在回归模型中探讨对监管的影响：如果 ONP 类型、口味的某些组合，和尼古丁浓度改善用户体验并增强滥用可能性，这些产品可以鼓励新的电子烟+ONP双重使用模式（例如，在无法抽电子烟时使用ONP）。可以向 FDA 提供拒绝营销申请或优先执行非法行为的证据针对这些特定 ONP 的营销可能会阻止尝试 ONP 的 AYA 成为以下产品的持久用户：使用遇险模式。 FDA 科学领域：行为和成瘾。