Harm reduction with pharmacotherapy for homeless adults with alcohol dependence

通过药物治疗减少酒精依赖无家可归成年人的危害

基本信息

批准号：
9315604
负责人：
Susan E Collins
金额：
$ 64.79万
依托单位：
UNIVERSITY OF WASHINGTON
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-08-01 至 2019-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9315604
关键词：
Abstinence Address Admission activity Adult Adverse event Affect Alcohol consumption Alcohol dependence Alcohols Attention Client Clinical Communities Complex Counseling County Criminal Justice Dependence Drops Effectiveness Emergency department visit Emergency medical service Feedback Formulation Frequencies Funding General Population Goals Harm Reduction Health Services Accessibility Homelessness Hospitals Housing Individual Injection of therapeutic agent Insurance Intervention Intramuscular Injections Jail Mediating Mediator of activation protein Medical Medical emergency Medication Management Morbidity - disease rate Motivation Naltrexone Opioid Receptor Outcome Participant Pharmaceutical Preparations Pharmacology Pharmacotherapy Placebo Effect Placebos Population Positioning Attribute Prevalence Proliferating Public Health Randomized Controlled Trials 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 mortality open label personalized approach phase 2 study pilot trial programs psychosocial public health relevance reduced alcohol use theories treatment effect

项目摘要

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®). 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效果甚微。针对该人群的需求而制定的更灵活、以客户为中心的方法（例如住房优先和酒精管理计划）已应用于该人群，并且可以有效减少饮酒。和相关问题以及利用公共资助的服务和相关成本，此类方法被称为减少危害干预措施，因为它们侧重于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。尽管社会心理、减少伤害的方法开始在这一人群中普及，但很少有药理学单位可以支持和加强这些努力，一种可以解决这一治疗差距的药物是缓释纳曲酮（XR-NTX；商品名）。 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 期研究采用四组 RCT（N=300）设计。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伤害服务的药理学辅助手段的功效。拟议的研究将包括为期 24 周的研究。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） - 与照常服务相比（所有参与者从社区机构收到的 TAU）这一提议的设计将使我们能够拆除主动治疗组件，从而检测注射管理和医疗关注的潜在“安慰剂效应”。在这项研究中，有三个主要具体目标：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。具体来说，我们努力使积极治疗能够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，我们将在公开场合测试治疗效果。资助服务费用（即紧急医疗服务、急诊室就诊、住院和县监狱）可以看出，XR-NTX、安慰剂和 HRC 组的公共资助服务成本将比 TAU 组显着降低。