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同时发生的严重公共卫生问题。不幸的是，以戒酒为基础的酒精治疗方法在吸引和成功治疗有酒精依赖的无家可归者方面收效甚微。因此，有人呼吁采取更灵活和以客户为中心的方法，以适应这一群体的需求。创新的、低障碍的方法（例如，住房优先和酒精管理方案）已在这一人群中应用，并有效地减少了酒精使用和相关问题，以及利用公共资助的服务和相关费用。这些方法被称为减少伤害干预措施，因为它们侧重于减少受影响个人及其社区的酒精相关伤害，而不需要承诺实现以戒酒为基础的目标。虽然社会心理、减少伤害的方法开始在这一人群中扩散，但很少有相应的药理学方法来支持和加强这些努力。一种可以弥补这一治疗差距的药物是缓释纳曲酮（XR-NTX；以Vivitrol(R)销售）。XR-NTX是一种阿片受体拮抗剂纳曲酮的30天缓释制剂，每月通过臀肌注射给药。拟议的II期研究的特点是一项四组随机对照试验（N=300），旨在测试XR-NTX作为社区机构为无家可归的酒精依赖者提供的现有社会心理伤害减少服务的药理学辅助手段的有效性。拟议的研究将包括一个24周的随访，并将测试3种积极治疗组合的相对疗效-1)XR-NTX+减少伤害咨询，2)安慰剂+减少伤害咨询和3)减少伤害咨询(HRC)-与所有参与者从社区机构接受的常规服务（TAU）相比。这一设计方案将使我们能够拆除积极的治疗成分，从而检测注射管理和医疗关注的潜在“安慰剂效应”

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.