Harm reduction with pharmacotherapy for homeless adults with alcohol dependence

描述（由申请人提供）：无家可归和酒精依赖通常是共同发生的严重公共卫生问题。不幸的是，基于戒酒的酒精治疗方法在参与和成功治疗酒精依赖的无家可归者方面效果甚微。因此，有人呼吁采取更加灵活和以客户为中心的办法，以适应这一群体的需要。创新的低壁垒办法（例如，住房第一和酒精管理计划）已应用于这一人群，并有效地减少了酒精使用和相关问题以及公共资助服务的利用和相关费用。这些方法被称为减少危害干预措施，因为它们侧重于减少酒精对受影响个人及其社区的危害，而不需要承诺实现基于戒酒的目标。虽然心理社会，减少伤害的方法开始扩散，这一人群，有几个药理学对应支持和加强这些努力。一种可以解决这种治疗差距的药物是缓释纳洛酮（XR-NTX;以Vivitrol（R）销售）。XR-NTX是阿片受体拮抗剂纳洛酮的30天缓释制剂，每月通过臀部肌肉注射给药。拟定的II期研究采用了一项四臂RCT（N=300），旨在测试XR-NTX作为社区机构向酒精依赖无家可归者提供的现有心理社会危害减轻服务的药理学辅助治疗的疗效。拟议的研究将包括24周的随访，并将测试3种活性治疗组合的相对功效-1）XR-NTX+减少伤害咨询，2）安慰剂+减少伤害咨询和3）仅减少伤害咨询（HRC）-与所有参与者从社区机构获得的常规服务（TAU）相比。这种拟议的设计将使我们能够拆除积极的治疗组成部分，从而检测潜在的“安慰剂效应”的管理注射和注意从医疗 专业.在这项研究中，有三个主要的具体目标。首先，我们将测试XR-NTX、安慰剂和HRC与TAU相比在减少酒精量、频率和酒精相关问题方面的相对功效。其次，我们将测试干预效果的假设中介。具体来说，我们假设积极治疗会促使改变的动机增加，渴望减少，这反过来又会介导积极治疗对酒精结果的影响。最后，我们将测试治疗对公共资助服务成本的影响（即，紧急医疗服务，急诊室访问，医院入院，县监狱）。据推测，XR-NTX，安慰剂和HRC组将显示出更大的减少公共资助的服务成本比TAU组。

DESCRIPTION (provided by applicant): Homelessness and alcohol dependence are commonly co-occurring and serious public health issues. Unfortunately, abstinence-based alcohol treatment approaches are minimally effective in engaging and successfully treating homeless individuals with alcohol dependence. There have therefore been calls for more flexible and client-centered approaches tailored to this population's needs. Innovative, low-barrier approaches (e.g., Housing First and alcohol management programs) have been applied with this population and are efficacious in reducing alcohol use and related problems as well as utilization of publicly funded services and associated costs. Such approaches have been referred to as harm-reduction interventions because they focus on reducing alcohol-related harm for affected individuals and their communities without requiring a commitment to abstinence-based goals. Although psychosocial, harm-reduction approaches are beginning to proliferate for this population, there are few pharmacological counterparts to support and enhance these efforts. One medication that could address this treatment gap is extended-release naltrexone (XR-NTX; marketed as Vivitrol(R)). XR-NTX is a 30-day, extended release formulation of the opioid receptor antagonist, naltrexone, and is administered monthly via gluteal intramuscular injection. The proposed Phase II study features a four- arm RCT (N=300) designed to test the efficacy of XR-NTX as a pharmacological adjunct to existing psychosocial harm-reduction services provided by community agencies to homeless people with alcohol dependence. The proposed study will include a 24-week follow-up and will test the relative efficacy of 3 active treatment combinations-1) XR-NTX+harm reduction counseling, 2) placebo+harm reduction counseling and 3) harm reduction counseling only (HRC)-compared to the services as usual (TAU) that all participants receive from community agencies. This proposed design will allow us to dismantle active treatment components and thereby detect potential "placebo effects" of both the administration of an injection and attention from a medical professional. In this study, there are three primary specific aims. First, we will test the relativ efficacy of XR-NTX, placebo and HRC compared to TAU in decreasing alcohol quantity, frequency and alcohol-related problems. Second, we will test hypothesized mediators of the intervention effects. Specifically, we hypothesize that the active treatments will precipitate increases in motivation to change and decreases in craving, which, in turn, will mediate the active treatment effects on alcohol outcomes. Finally, we will test treatment effects on publicly funded service costs (i.e., emergency medical services, ER visits, hospital admissions, and county jail). It is hypothesized that XR-NTX, placebo and HRC groups will show greater decreases in publicly funded service costs than the TAU group.