A Trial to Prevent Opioid Overdose: E.D. Based Intervention & Take-home Naloxone

描述（由申请人提供）：涉及药物阿片类药物的致命过量在过去十年中急剧增加，超过了与海洛因有关的过量，并且是美国大部分地区药物过量的主要原因。在西雅图-金县，2009年75%的药物过量涉及药物阿片类药物和/或海洛因。阿片类药物过量、海洛因和药物是可预防和可逆的。最近的研究表明，有过量风险的阿片类药物使用者有更高的艾滋病毒风险行为率。最初依赖药物阿片类药物的新兴海洛因使用者群体（根据2011年西雅图的一项调查，占海洛因使用者的39%）的艾滋病毒风险认知和艾滋病毒检测率明显较低。研究表明，可以成功地对吸毒者及其伴侣进行培训，使其能够识别并逆转纳洛酮的过量使用。尽管在15个州使用纳洛酮（OOPIN）进行了有效的海洛因过量预防和干预项目，数千例过量逆转，没有发生严重的不良事件，但尚未对这些项目对随后的海洛因过量服用率进行严格的研究。目前还没有针对药物阿片类药物过量高风险使用者的OOPIN项目或研究。急诊科（ED）的设置在识别和招募海洛因和药物阿片类药物过量的高风险人群方面有着巨大的希望：1)本提案的ED研究地点为西雅图需要治疗急性阿片类药物相关医疗问题的人提供了大多数服务，2)需要紧急医疗护理的患者可能会增加他们对阿片类药物潜在危害的关注。这种情况的独特之处在于有可能识别出高风险的阿片类药物使用者。使用简短行为改变咨询（BBCC）的ED干预已被证明可以显著改善健康行为，如酒精使用和伤害，增加进入药物治疗以及降低成本。关于BBCC对阿片类药物相关危险行为的影响，证据是有希望的，但有限。这项前瞻性、随机ED试验将研究OOPIN与BBCC联合干预对海洛因使用者（n=500）和药物阿片类药物过量高风险使用者（n=500）的有效性。主要结果是随后的阿片类药物过量，通过在3个月、6个月和12个月进行的随访访谈以及长达24个月的行政记录（即医疗记录、救护车响应和死亡证明）确定。需要研究的假设包括：干预接受者将具有：1)更低的阿片类药物过量率，2)减少药物使用和过量风险行为，3)更适当的医疗保健利用，以及4)更低的医疗保健总成本。我们还将确定艾滋病毒风险行为的流行程度以及干预对这些行为的影响。优秀的数据系统以及临床实践和政策的几个特点使西雅图成为进行这项研究的理想场所。研究小组是唯一有资格进行这项研究的人，并将采用他们有多年研究和临床经验的干预措施。

DESCRIPTION (provided by applicant): Fatal overdoses involving pharmaceutical opioids have increased dramatically over the past decade, surpassing those related to heroin, and are the leading cause of drug overdose in much of the U.S. In Seattle- King County, 75% of drug overdoses involved pharmaceutical opioids and/or heroin in 2009. Opioid overdoses, heroin and pharmaceutical, are preventable and reversible. Recent research suggests that opioid users at risk for overdose have higher rates of HIV risk behaviors. The emergent group of heroin users who were initially dependent on pharmaceutical opioids (39% of heroin users according to a 2011 Seattle survey) has significantly lower HIV risk perceptions and HIV testing rates. Research indicates that drug users and their partners can be successfully trained to recognize and reverse overdoses with naloxone. Despite active heroin overdose prevention and intervention programs with naloxone (OOPIN) in 15 states with thousands of overdose reversals and no serious adverse events, rigorous studies of these programs on rates of subsequent heroin overdoses have not been conducted. No OOPIN programs or studies have yet been implemented for pharmaceutical opioid users at elevated risk for overdose. The Emergency Department (ED) setting holds great promise for identifying and recruiting those at elevated risk of heroin and pharmaceutical opioid overdose: 1) the ED study site for this proposal provides most services to those needing care for acute opioid related medical problems in Seattle, and 2) patients¿ need for urgent medical attention may heighten their concern about potential harms from opioids. Unique to this setting is the potential to identify high risk pharmaceutical opioid users. ED interventions using brief behavior change counseling (BBCC) have been shown to significantly improve health behaviors such as alcohol use and injury, to increase entry into drug treatment as well as to reduce costs. Evidence is promising, but limited, regarding the impact of BBCC on opioid related risk behaviors. This prospective, randomized ED trial will study the effectiveness of an intervention that combines OOPIN with BBCC for both heroin users (n=500) and pharmaceutical opioid users at elevated risk for overdose (n=500). The primary outcome is subsequent opioid overdoses, ascertained by follow up interviews conducted at 3, 6 and 12 months as well as via administrative records for up to 24 months (i.e. medical records, ambulance responses, and death certificates). Hypotheses to be investigated include that the intervention recipients will have: 1) lower rates of opioid overdose, 2) reduced drug use and overdose risk behaviors, 3) more appropriate health care utilization, and 4) lower total health care costs. We will also determine the prevalence of HIV risk behaviors and the impact of the intervention on these behaviors. Excellent data systems and several features of clinical practice and policy make Seattle the ideal place to conduct this research. The study team is uniquely qualified to conduct this study and will be adapting interventions with which they have years of research and clinical experience.