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

项目摘要/摘要 酒精使用障碍(AUD)在人群中是一个普遍存在的公共卫生问题 无家可归的以无家可归为特征的无家可归者之间的这种健康差距反映在 与酒精相关的死亡率和发病率很高。少数族裔和女性经历的不成比例 与酒精有关的伤害和与酒精有关的高死亡率和发病率。这种差距在以下人群中表现得更为突出 少数族裔和无家可归的妇女。最近的一项随机对照试验(RCT)，其危害 药物治疗还原治疗研究(HARP；R01AA022309；PI：Susan Collins博士)，测试 缓释纳曲酮(XR-NTX；VIVITROL®)在城市人群中的减害效果 经历无家可归和澳元死亡的成年人。这项四臂随机对照试验评估了缓释剂的效果 纳曲酮和减少伤害咨询(XR-NTX+HRC)，安慰剂用药组和减少伤害 咨询(安慰剂+HRC)和单独减少伤害咨询(HRC)，与以社区为基础的比较 支持服务(TAU)。减少行为伤害治疗与XR-NTX相结合显示改善 酒精和生活质量结果，强调其对经历无家可归和澳元死亡的人的效用。 虽然减少行为伤害治疗与XR-NTX相结合已被发现是可行的，可以接受的， 在经历AUD无家可归的人中是有效的，XR-NTX的研究还很少 对于NAI、黑人成年人和女性中的AUD，没有研究表明XR-NTX与行为伤害成对 在这些历史上代表性不足的人群中进行减少治疗，以进行AUD治疗研究。审查 针对边缘人群的减少药物行为伤害治疗与NIH/NIAAA最近的研究一致 战略计划，包括承诺“支持研究以更好地了解健康差距和 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竖琴是否是一种 可接受的不同种族和性别的待遇(目标1)。此外，这项研究将使用不变性测试来评估 竖琴跨越种族和性别的功效(目标2)。具体地说，它将检验这样一个假设，即干预 与TAU相比，各HARP治疗组(HRC+XR-NTX、HRC+安慰剂、HRC)的效果如下 在种族(NAI、黑人、白人)和性别(女性和男性)之间不变。研究结果将作为试点数据 告知被边缘化、暂住人口中代表不足的少数群体未来的治疗发展 人口。此外，拟议的研究将为申请人提供培训经验，使其 告知她关于在边缘人群中减少伤害治疗的研究计划。具体地说， 拟议的培训和研究将促进酒精知识的获取和整合 干预措施；随机对照研究方法和数据分析；与酒精有关的健康不平等；以及治疗 在被边缘化的人群中促进发展；以及改进赠款和传播。

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.