Influence of Mint Flavorings and pH on Nicotine Absorption in Smokeless Tobacco

描述(申请人提供)：这项拟议的研究是对无烟烟草(SLT)产品中的薄荷香料进行的第一次系统调查。将确定pH值和薄荷调味料(薄荷醇和冬青)对尼古丁的主要和交互影响。市场上可获得的薄荷味(目标1)SLT产品的全面样本将对pH和调味成分进行定量分析。这些信息将被用来确定pH值和调味料浓度的范围，以修正非调味性研究SLT参比产品(目标2)。在双盲受试者内试验设计(目标3)中，经验丰富的SLT使用者将在实验室使用这些改进的产品来检查pH和薄荷调味料对尼古丁吸收的影响。参与者将被随机分成两个薄荷组(薄荷组或冬青组)，并将参与5个实验阶段：1)参考产品，2)高pH，低薄荷，3)高pH，高薄荷，4)低pH，低薄荷，以及5)低pH，高薄荷。主要的结果变量将是尼古丁暴露、心血管效应以及对体验和产品特征的主观评估。过去的研究依赖于商业产品之间的比较。虽然SLT产品可以根据感兴趣的特性(例如，pH)进行选择，但可能存在其他未知和混杂的添加剂。在拟议的研究中，通过添加调味品和化合物来改变pH值，将对单一参比产品进行参数修改，从而消除了这一担忧。本研究的结果将向公共卫生界通报流行调味品对尼古丁暴露的影响，并提供一个研究SLT产品的新模型，以帮助那些通过循证知识负责任地指导烟草监管的人。

DESCRIPTION (provided by applicant): The proposed research represents the first systematic investigation of mint flavorings in smokeless tobacco (SLT) products. Main and interactive effects of pH and mint flavorings (menthol and wintergreen) on nicotine will be identified. A comprehensive sample of commercially available SLT products identified as mint flavored (Aim 1) will quantitatively analyzed for pH and flavoring components. The information will be used to determine ranges of pH and flavoring concentrations to amend a non-flavored research SLT referent product (Aim 2). In a double-blind, within-subject experimental design (Aim 3), experienced SLT users will utilize these amended products in the laboratory to examine the effects of pH and mint flavorings on nicotine absorption. Participants will be randomized to one of two mint groups (menthol or wintergreen) and will engage in 5 experimental sessions: 1) referent product, 2) high pH, low mint, 3) high pH, high mint, 4) low pH, low mint, and 5) low pH, high mint. The main outcome variables will be nicotine exposure, cardiovascular effects and subjective evaluations of the experience and product characteristics. Past studies have relied upon comparisons between commercial products. Although SLT products can be selected on a characteristic of interest (for example, pH), there may be other unknown and confounding additives present. This concern is obviated in the proposed research where a single referent product will be parametrically amended by the addition of flavorings and compounds to change pH. Results from the present study will inform the public health community about the effects of popular flavorings on nicotine exposure and offer a new model to study SLT products to assist those who responsibly guide tobacco regulation through evidenced-based knowledge.