Race and sex as moderators of harm reduction pharmacobehavioral treatment outcomes for alcohol use disorder among people experiencing homelessness

项目总结/摘要 酒精使用障碍（AUD）是人群中普遍存在的问题性公共卫生问题 以无家可归为特点。无家可归者之间的这种健康差距反映在 与酒精有关的高死亡率和发病率。少数种族和妇女遭受不成比例的 与酒精有关的伤害以及与酒精有关的高死亡率和发病率。这一差距在 少数民族和无家可归的妇女。最近的一项随机对照试验（RCT）， 药物治疗减量治疗研究（HaRP; R 01 AA 022309; PI：Susan柯林斯博士），测试了 缓释纳洛酮（XR-NTX; VIVITROL®）在城市人群中减少危害治疗效果 无家可归的成年人和澳元。这项4组RCT评估了缓释剂的作用， 纳洛酮和减少伤害咨询（XR-NTX + HRC），安慰剂药物组和减少伤害 咨询（安慰剂+ HRC）和单独的减少伤害咨询（HRC），与基于社区的 支持服务（TAU）。行为伤害减少治疗结合XR-NTX显示出改善 酒精和生活质量的结果，强调其效用的人经历无家可归和澳元。 虽然已经发现与XR-NTX组合的行为危害减少治疗是可行的、可接受的， 在经历无家可归的AUD人群中有效，缺乏对XR-NTX的研究 对于NAI和黑人成年人和女性中的AUD，没有XR-NTX与行为伤害配对的研究 在这些历史上代表性不足的人群中进行AUD治疗研究。审查 针对边缘化人群的药物行为危害减少治疗与NIH/NIAAA最近的 战略计划，包括承诺“支持研究，以更好地了解健康差距， 为高危人群制定干预措施。”拟议的研究将使用内容分析来评估HaRP是否是一个 在种族和性别之间接受治疗（目标1）。此外，该研究将使用不变性检验来评估 HaRP在种族和性别之间的疗效（目标2）。具体来说，它将测试的假设，即干预 与TAU相比，每个HaRP治疗组（HRC+XR-NTX，HRC+安慰剂，HRC）的效果是 跨种族（NAI、黑人、白色）和性别（女性和男性）不变。研究结果将作为试点数据 为边缘化的、短暂的、未被充分代表的少数群体提供未来治疗发展的信息， 人口此外，拟议的研究将为申请人提供培训经验， 告知她的研究方案在边缘化人群中减少伤害的治疗。具体而言是 拟议的培训和研究将促进获取和整合关于酒精的知识， 干预措施;随机对照试验方法和数据分析;酒精相关的健康不公平;以及治疗 边缘化人口的发展;以及完善宣传和传播。

PROJECT SUMMARY/ABSTRACT Alcohol use disorder (AUD) is a pervasive and problematic public health concern among populations characterized by homelessness. This health disparity among individuals who are homeless is reflected in the high rates of alcohol-related mortality and morbidity. Racial minorities and women experience disproportionate alcohol-related harm and high rates of alcohol-related mortality and morbidity. This disparity is elevated among racial minorities and women who are homeless. A recent randomized controlled trial (RCT), the Harm Reduction Treatment with Pharmacotherapy study (HaRP; R01AA022309; PI: Dr. Susan Collins), tested the efficacy of harm reduction treatment with extended-release naltrexone (XR-NTX; VIVITROL®) among urban adults experiencing homelessness and AUD. This 4-arm RCT assessed the effects of extended-release naltrexone and harm reduction counseling (XR-NTX + HRC), a placebo medication group and harm reduction counseling (placebo + HRC), and harm reduction counseling alone (HRC), compared to community-based supportive services (TAU). Behavioral harm reduction treatment combined with XR-NTX was shown to improve alcohol and quality of life outcomes, underscoring its utility for people experiencing homelessness and AUD. While behavioral harm reduction treatment combined with XR-NTX has been found to be feasible, acceptable, and efficacious among people experiencing homelessness with AUD, there is a dearth of research on XR-NTX for AUD among NAI and Black adults and women, and no studies of XR-NTX paired with behavioral harm reduction treatment in these historically underrepresented groups for AUD treatment research. Examination of pharmacobehavioral harm reduction treatment for marginalized populations aligns with NIH/NIAAA's recent strategic plan, including their commitment to “supporting studies to better understand health disparities and to develop interventions for at-risk groups.” The proposed study will use content analysis to assess if HaRP is an acceptable treatment across race and sex (Aim 1). Additionally, the study will use invariance testing to assess the efficacy of HaRP across race and sex (Aim 2). Specifically, it will test the hypothesis that the intervention effects of each HaRP treatment group (HRC+XR-NTX, HRC+Placebo, HRC) compared to the TAU are invariant across race (NAI, Black, white) and sex (female and male). Research findings will serve as pilot data to inform future treatment development for underrepresented minorities among a marginalized, transient population. Additionally, the proposed study would provide the Applicant with training experiences that will inform her research program on harm reduction treatment among marginalized populations. Specifically, the proposed training and research would facilitate the acquisition and integration of knowledge on alcohol interventions; RCT methodology and data analysis; alcohol-related health inequities; and treatment development among marginalized populations; as well as refine grantsmanship and dissemination.