Project 3

项目3

• 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
• 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

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.

项目概要：项目3（P3） P3研究了ONP的哪些特征增加了年轻成人vapers的滥用倾向和产品吸引力。到 为了实现这一目标，P3将使用虚拟访问（Zoom）在全国范围内招募320名当前电子烟用户的样本 年龄在21-25岁之间，不打算戒烟，并愿意尝试ONP。我们将进行产品上诉 和滥用倾向测试，采用混合析因设计，按产品类型（尼古丁袋与非药用）改变ONP 口香糖）×风味（薄荷与水果）×尼古丁浓度（4 mg与2 mg）。目的1是评估感官吸引力 假设：1a）根据初步数据，我们预测更大的吸引力（例如，愿意再次使用）和 口香糖与小袋相比以及低尼古丁与高尼古丁相比的理想感官属性。鉴于薄荷能掩盖尼古丁 苦味和刺激性的影响，我们假设：1b）薄荷将抑制感官吸引力降低（和 高尼古丁与低尼古丁（尼古丁×香料相互作用）的刺激增强）效应。目的2是表征ONP 滥用责任使用上一次上诉会议中评级最高的薄荷和水果ONP， 两种口味将在30分钟标准化ONP自我给药后通过以下方式测量：i）阳性主观药物 影响、戒断/冲动缓解、ONP奖励价值的行为经济学指标和新型双重用途责任 措施（即，当电子烟的使用受到限制时使用ONP的动机），以及ii）在 在1周随访中提供研究ONP。假设：2a）主观药物作用，戒断/冲动缓解，ONP 高尼古丁与低尼古丁的奖励值、需求指数和自然自我给药将更大; 2b） ONP奖励值、需求指数和自然自我给药对于口香糖（与袋相比）将更高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×香料相互作用）。目的3是审查旧名警察的上诉， 性/性别少数（相对于多数）参与者的虐待倾向。我们将纳入20%（n = 64）的自身- 确定SGM参与者。假设：3a）鉴于先前的工作，我们预测主观和行为指数 SGM的上诉和滥用责任将高于异性恋/顺性别参与者。虽然我们 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 将在回归模型中进行探索。对监管的影响：如果ONP类型、风味、 和尼古丁浓度改善了用户体验并增强了滥用倾向，这些产品可以 鼓励新的电子烟+ONP双重使用模式（例如，在不可能使用电子烟时使用ONP）。这 可以向FDA提供证据，证明拒绝营销申请或优先执行非法 针对这些特定ONP的营销可能会阻止尝试ONP的AYA成为持久用户， 有害的使用模式。 FDA科学领域：行为和成瘾。