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

描述（由申请人提供）：在过去十年中，涉及药物阿片类药物的致命过量急剧增加，超过了与海洛因相关的过量，并且是美国大部分地区药物过量的主要原因。在西雅图-金郡，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，是可以预防和可逆的。最近的研究表明，有吸毒过量风险的阿片类药物使用者的艾滋病毒风险行为发生率更高。最初依赖药物阿片类药物的海洛因使用者的新兴群体（根据2011年西雅图的调查，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显着降低。研究表明，可以成功地训练吸毒者及其伴侣识别和逆转纳洛酮过量。尽管在15个州开展了积极的海洛因过量预防和纳洛酮（OOPIN）干预计划，有数千例过量逆转，没有严重不良事件，但尚未对这些计划进行严格的研究，以确定随后的海洛因过量率。目前还没有针对药物过量风险升高的阿片类药物使用者实施OOPIN计划或研究。急诊科（艾德）设置在识别和招募海洛因和药物阿片类药物过量风险升高的患者方面具有很大的希望：1）本提案的艾德研究中心为西雅图需要治疗急性阿片类药物相关医疗问题的患者提供大部分服务，2）患者需要紧急医疗护理可能会增加他们对阿片类药物潜在危害的担忧。这种环境的独特之处在于有可能识别高风险的阿片类药物使用者。艾德干预使用简短的行为改变咨询（BBCC）已被证明可以显着改善健康行为，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对阿片类药物相关风险行为的影响，证据是有希望的，但有限。这项前瞻性随机艾德试验将研究OOPIN与BBCC相结合的干预措施对海洛因使用者（n=500）和药物过量风险升高的阿片类药物使用者（n=500）的有效性。主要结局是随后的阿片类药物过量，通过在3、6和12个月时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。研究的假设包括：1）阿片类药物过量的发生率较低，2）药物使用和过量风险行为减少，3）更适当的医疗保健利用，4）总医疗保健费用较低。我们还将确定艾滋病毒危险行为的流行程度以及干预措施对这些行为的影响。优秀的数据系统和临床实践和政策的几个特点使西雅图进行这项研究的理想场所。该研究团队是唯一有资格进行本研究的团队，他们将采用具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.