Harm reduction with pharmacotherapy for homeless adults with alcohol dependence

通过药物治疗减少患有酒精依赖的无家可归成年人的危害

• 批准号: 8894343
• 负责人: Susan E Collins
• 金额: $ 65.09万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-08-01 至 2016-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8894343
• 关键词: Abstinence; Address; Admission activity; Adult; Adverse event; Affect; Alcohol dependence; Alcohols; Attention; Client; Clinical; Communities; Complex; Counseling; County; Criminal Justice; Dependence; Drops; Drug Formulations; Effectiveness; Emergency department visit; Emergency medical service; Feedback; Frequencies; Funding; General Population; Goals; Harm Reduction; Health; Homelessness; Hospitals; Housing; Individual; Injection of therapeutic agent; Insurance; Intervention; Intramuscular Injections; Jail; Marketing; Mediating; Mediator of activation protein; Medical; Medical emergency; Medication Management; Morbidity - disease rate; Motivation; Naltrexone; Opioid Receptor; Outcome; Participant; Pharmaceutical Preparations; Pharmacotherapy; Placebo Effect; Placebos; Population; Positioning Attribute; Prevalence; Proliferating; Public Health; Randomized Controlled Trials; Relative (related person); Research; Resources; Sample Size; Services; Symptoms; System; Testing; Time; active method; alcohol abuse therapy; alcohol behavior; alcohol craving; alcohol related problem; arm; base; behavior change; clinically significant; cost; craving; design; drinking; effective therapy; efficacy testing; experience; flexibility; follow-up; innovation; interest; intervention effect; open label; phase 2 study; pilot trial; programs; psychosocial; reduced alcohol use; theories; treatment effect

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.

描述（由申请人提供）：无家可归和酒精依赖是常见的同时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吸引和成功治疗患有酒精依赖的无家可归者方面收效甚微。因此，有人呼吁针对这一人群的需求采取更灵活、以客户为中心的方法。创新的、低门槛的方法（例如住房优先和酒精管理计划）已应用于这一人群，并且可以有效减少酒精使用和相关问题以及公共资助服务的利用和相关成本。此类方法被称为减少危害干预措施，因为它们的重点是减少受影响个人及其社区与酒精相关的危害，而不需要承诺实现基于戒酒的目标。尽管心理社会、减少伤害的方法开始在这一人群中普及，但很少有药理学对应物来支持和加强这些努力。可以解决这一治疗缺口的一种药物是缓释纳曲酮（XR-NTX；商品名为 Vivitrol(R)）。 XR-NTX 是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 期研究以四组随机对照试验 (N=300) 为特色，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社会心理伤害减少服务的药理辅助药物的功效。拟议的研究将包括 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）仅减少伤害咨询（HRC） )-与所有参与者从社区机构获得的照常服务 (TAU) 相比。这种拟议的设计将使我们能够拆除活性治疗成分，从而检测注射给药和医疗人员关注的潜在“安慰剂效应” 专业的。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 在减少饮酒量、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，我们假设积极治疗将促进改变动机的增加和渴望的减少，这反过来又会调节积极治疗对酒精结果的影响。最后，我们将测试对公共资助服务成本（即紧急医疗服务、急诊室就诊、住院和县监狱）的治疗效果。假设 XR-NTX、安慰剂和 HRC 组的公共资助服务成本将比 TAU 组显示出更大的下降。