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: 8704413
• 负责人: Susan E Collins
• 金额: $ 65.77万
• 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 2018-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8704413
• 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 Situation; Emergency medical service; Feedback; Frequencies; Funding; General Population; Goals; Harm Reduction; Homelessness; Hospitals; Housing; Individual; Injection of therapeutic agent; Insurance; Intervention; Intramuscular Injections; Jail; Marketing; Mediating; Mediator of activation protein; Medical; 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; Visit; 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; public health relevance; 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通常是同时发生和严重的公共卫生问题。不幸的是，基于禁欲的酒精治疗方法在参与并成功地治疗无家可归者的酒精依赖人方面至少有效。因此，已经呼吁采用针对该人群需求量身定制的更灵活和以客户为中心的方法。创新的低性方法（例如，住房第一和酒精管理计划）已适用于该人群，并有效地减少酒精使用和相关问题以及利用公共资助的服务和相关成本。这种方法被称为减少危害干预措施，因为它们专注于减少对受影响个人及其社区的危害，而无需承诺基于禁欲的目标。尽管该人群的社会心理，减少伤害方法开始扩散，但很少有药理学对应物支持和加强这些努力。一种可以解决此治疗差距的药物是扩展释放的纳曲酮（XR-NTX；以Vivitrol（R）销售）。 XR-NTX是阿片受体拮抗剂Naltrexone的30天，扩展释放公式，每月通过臀肌内注射每月给药。拟议的II期研究具有四臂RCT（n = 300），旨在测试XR-NTX作为药理学辅助的功效，以对社区机构为无家可归者依赖的无家可归者提供的现有社会心理减少危害服务。拟议的研究将包括24周的随访，并将测试3个主动治疗组合的相对疗效1）XR-NTX+减少危害减少咨询，2）安慰剂+减少损害咨询和3）仅损害减少咨询（HRC），与所有参与者一样从社区机构中获得。该提出的设计将使我们能够拆除主动治疗成分，从而发现注射给药的潜在“安慰剂效应”和医疗的注意 专业的。在这项研究中，有三个主要的特定目标。首先，我们将测试XR-NTX，安慰剂和HRC的相对疗效，而tau减少了酒精量，频率和与酒精相关的问题。其次，我们将测试干预效应的假设介体。具体而言，我们假设主动治疗将导致渴望变化和减少动机的增加，这反过来又会介导对酒精结果的主动治疗影响。最后，我们将测试对公共资助的服务成本（即紧急医疗服务，急诊就诊，住院和县监狱）的治疗效果。假设XR-NTX，安慰剂和HRC组将比TAU组显示出公共资助的服务成本的减少。