Secondary Analyses of Clinical Trial Data to Understand Factors Associated with Alcohol Use Among Alaska Native Populations

项目摘要/摘要 该项目提案反映了一项协作和协调的培训和研究计划，将促进 申请者向阿拉斯加原住民(AN)独立酒精研究人员的过渡 社区。也就是说，提出了四个培训目标：1)培养酒精治疗和临床方面的专门知识 在AN人群中进行试验研究；2)熟练掌握创伤应激研究及其影响 酒精使用的创伤；3)获得方法学和高级量化技能 设计和分析临床试验；4)进一步发展科学写作技能，加强出版 作为一名酒精研究人员和该领域未来的领导者，记录并专业成长。这些技能将是 应用于开展两个随机对照试验数据集的检验项目 酒精使用障碍(AUD)、问题饮酒、吸烟、创伤、文化和生活质量(QOL)。临床 试验数据将来自(1)纳曲酮研究39，纳曲酮和舍曲林治疗糖尿病的临床试验 和(2)HEALTHH研究42，一项针对以下人群的临床试验 吸烟，包括两种促进心脏健康的干预措施(A)戒烟和身体健康 活动和(B)服药依从性和心脏健康饮食。研究检查中的表示法 1986至2005年间对严重精神障碍的临床试验发现，1万名参与者中没有一人 是来自美国印第安人(AI)或遗产5。此外，对AI/AN的2014年进行了详尽的文献搜索 心理健康治疗干预只进行了两项临床试验。这是非常麻烦的，因为 事实是，一个人经历了不成比例的高AUD率，有问题的饮酒，与酒精相关的 伤害和死亡、吸烟、健康差距、创伤后应激障碍和创伤应激障碍的高比率以及系统性种族主义 和压迫2，5，12，16，25，48。这些因素会影响文化、幸福感和酒精治疗的结构 访问、利用率和结果8，13，23。因此，这个项目将探索创伤、吸烟和 文化影响饮酒和生活质量结果。目标1是检查酒精使用的预测因素和调节因素 使用来自纳曲酮研究的数据和目标2检查纳曲酮在人群中的治疗效果 饮酒对两种针对可改变风险的文化定制干预措施疗效的影响 心血管健康和这些干预措施对饮酒人群的影响 健康研究。从这些目标得到的数据有可能确定以下问题的性质和影响 与酒精使用、治疗和结果相关的因素，这对公共健康非常重要 重要性。此外，这些结果对发展创伤-知情的、文化衍生的、 针对一个人群的多层次酒精治疗干预。

Project Summary/Abstract This project proposal reflects a collaborative and coordinated training and research plan that will facilitate the applicant’s transition towards becoming an independent alcohol researcher within Alaska Native (AN) communities. Namely, four training goals are proposed: 1) Develop expertise in alcohol treatment and clinical trials research within the AN population; 2) Obtain proficiency in traumatic stress research and the impact of trauma on alcohol use among AN people; 3) Acquire methodological and advanced quantitative skills for designing and analyzing clinical trials; and 4) Further develop scientific writing skills, strengthen publication record, and grow professionally as an AN alcohol researcher and future leader in the field. These skills will be applied to carrying out the proposed project of examining two randomized control trial datasets related to alcohol use disorder (AUD), problematic drinking, smoking, trauma, culture, and quality of life (QOL). Clinical trials data will be from (1) the Naltrexone Study39, a clinical trial of naltrexone and sertraline for the treatment of AUD among an AN and non-Native sample; and (2) the HEALTHH Study42, a clinical trial for people who smoke tobacco that includes two interventions to promote heart health (a) tobacco cessation and physical activity and (b) medication adherence and a heart healthy AN diet. Research examining AN representation in clinical trials for major mental disorders between 1986 and 2005 found that not one of the 10,000 participants were from American Indian (AI) or AN heritage5. Moreover, an exhaustive literature search in 2014 of AI/AN mental health treatment intervention resulted in only two clinical trials. This is more than troublesome given the fact that AN people experience disproportionately high rates of AUD, problematic drinking, alcohol-related injury and death, smoking, health disparities, high rates of PTSD and traumatic stress, and systemic racism and oppression2,5,12,16,25,48. These factors impact the very fabric of AN culture, wellbeing, and alcohol treatment access, utilization, and outcomes8,13,23. Thus, this project will explore the extent to which trauma, smoking, and culture impacts drinking and QOL outcomes. Aim 1 is to examine predictors of alcohol use and moderators of naltrexone treatment effects among AN people using data from the Naltrexone Study and Aim 2 is to examine the impact of drinking on the efficacy of two culturally tailored interventions targeting modifiable risks for cardiovascular health and the effects of these intervention on drinking among AN people using data from The HEALTHH Study. Resultant data from these aims have the potential to identify the nature and impacts of factors associated with alcohol use, treatment, and outcomes among AN people, which is of great public health importance. Additionally, the results have implications for developing trauma-informed, culturally derived, multilevel alcohol treatment interventions for AN people.