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检查了ONPS的哪些特征会增加滥用责任和年轻成人Vapers的产品外观。到这样做，P3将使用虚拟（Zoom）访问来招募320个当前电子烟用户的全国样本年龄在21-25岁之间，他们不打算退出烟雾并开放尝试ONPS。我们将进行产品外观以及混合阶乘设计中的滥用责任测试，其产品类型各不相同（Nicotine Pouch诉非中心口香糖）×风味（薄荷诉水果）×尼古丁浓度（4mgv。2mg）。目标1是评估感觉的外观假设：1a）基于初步数据，我们预测外观更大（例如，再次使用的意愿）和口香糖与小袋和低尼古丁的理想感觉属性。鉴于薄荷面具尼古丁的我们假设苦味和刺激性的效果：1b）薄荷会抑制降低感觉的外观（和高尼古丁（尼古丁×风味相互作用）的刺激性增强）。目标2是表征ONP 虐待责任。使用上一次出场会议中评分最高的薄荷和水果ONP，虐待责任两种口味将在30分钟后通过以下方式测量：i）阳性主观药物效果，提款/敦促缓解，ONP奖励价值的行为经济指数以及新颖的双重使用责任措施（即，在使用电子烟时使用ONP的动机），以及ii）自然主义使用在1周的随访中提供研究ONP。假设：2a）主观药物影响，提取/急促缓解，ONP 对于高尼古丁，奖励价值，需求指数和自然主义的自我管理将更大； 2b） ONP奖励价值，需求指数和自然主义的自我给药将更高（vs. pouch）2c） ONP奖励价值，需求指数和自然主义自我给药的薄荷比果实要高于水果，特别是在高尼古丁状况（尼古丁×风味相互作用）下。 AIM 3是检查ONP外观和性/性别少数群体（相对于多数）参与者的虐待责任。我们将包括20％（n = 64）自我确定了SGM参与者。假设：3a）给定的工作，我们预测主观和行为指数在SGM与异性恋/偶然的参与者中，上诉和虐待责任将更高。虽然我们有没有假设SGM会减轻风味，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索。对调节的影响：如果ONP类型的某些组合，口味，尼古丁的浓度改善了用户体验并增强了滥用责任，这些产品可以鼓励新的电子烟+ONP双重使用模式（例如，有时在无法进行烟雾时使用ONP）。这可以向FDA提供证据表明拒绝营销申请或优先执行非法的证据这些特定的ONP的营销可能会阻止AYA尝试使用ONP的AYA与有害的使用模式。 FDA科学领域：行为和成瘾。