Interim Treatment: Leveraging buprenophine + technology to bridge waitlist delays

描述（由申请人提供）：尽管激动剂维持治疗阿片类药物依赖的有效性无可争议，但目前的能力不足以满足美国和国际上的需求。事实上，数量惊人的诊所都有大量的等待治疗的名单。患者可以在这些等候名单上停留数年，使他们在此期间面临非法使用药物、犯罪活动、传染病、过量服用和死亡的高风险。在获得治疗方面的这些延误是广泛提供有效阿片类药物治疗的重大障碍，迫切需要制定创造性的新方法来减轻这些延误。我们在这个应用程序的总体目标是开发一种新的过渡丁丙诺啡治疗（IBT），可以弥合治疗获得的延迟。我们的综合治疗方案包括五个关键组成部分，每个部分都是为了最大限度地提高患者对阿片类药物依赖的药物治疗的可及性，同时最大限度地减少依从性、滥用和转移：丁丙诺啡、计算机依从性监测、通过交互式语音应答提供的移动健康临床支持、自动随机回调尿液分析和依从性监测，以及通过iPad提供的HIV+肝炎教育。这项I期行为和综合治疗开发应用的主要目的是在一项为期12周的随机试验中评估IBT的可行性和初步疗效，在该试验中，70名阿片类药物依赖的成年人等待激动剂维持，随机接受IBT （n=35）或继续等待名单对照条件（WLC; n=35）。在第12周之前尚未进入治疗的WLC参与者将有机会在那时过渡到IBT，提供额外的受试者内部数据，以评估IBT干预的有效性。拟议的研究在几个重要方面具有创新性：通过促进消除阿片类药物治疗的等候名单，它代表了对现状的重大背离，并将在如何概念化和交付阿片类药物依赖的治疗方面产生根本性转变。IBT的成分是非常新颖的，无论是单独还是作为阿片类药物依赖的综合临时治疗方案。这项研究将首次调查IBT在患者和环境中的效用，这些患者和环境将从IBT中获益最多。我们还提出了一种多管齐下的传播方法，以确保我们的工作能够很容易地转移到临床实践中，并将对阿片类药物依赖的现实治疗产生直接影响。总的来说，拟议的项目将产生一个高度创新的技术辅助药物治疗方案，可以广泛传播，以增加获得挽救生命的阿片类药物治疗的机会。这项建议的总体和具体目标与国家药物开发协会改善药物滥用治疗的可及性、执行和有效性的使命直接相关。

DESCRIPTION (provided by applicant): Despite the undisputed effectiveness of agonist maintenance for treating opioid dependence, current capacity is inadequate to meet need in the U.S. and internationally. Indeed, an alarming number of clinics have extensive waitlists for treatment slots. Patients can remain on these waitlists for years, placing them at elevated risk for illicit drug use, criminal activity, infectious disease, overdose and mortality during this perod. These delays in treatment access represent a significant barrier to the widespread delivery of effective opioid treatment, and there is a critical need to develop creative new approaches for mitigating these delays. Our overarching goal in this application is to develop a novel Interim Buprenorphine Treatment (IBT) that can bridge delays in treatment access. Our integrative treatment package includes five key components, each strategically chosen to maximize patient access to pharmacotherapy for opioid dependence while minimizing nonadherence, abuse and diversion: Buprenorphine, Computerized adherence monitoring, mHealth clinical support delivered via Interactive Voice Response, Automated random call-backs for urinalysis and adherence monitoring, and HIV+Hepatitis Education delivered via iPad. The Primary Aim of this Stage I Behavioral and Integrative Treatment Development application is to evaluate the feasibility and initial efficacy of IBT in a 12-week randomized trial in which 70 opioid-dependent adults wait-listed for agonist maintenance are randomized to receive IBT (n=35) or continue in a Waitlist Control condition (WLC; n=35). WLC participants who have not entered treatment by Week 12 will be offered the opportunity to cross over to IBT at that time, contributing additional within-subject data with which to evaluate the efficacy of the IBT intervention. The proposed research is innovative in several important ways: By facilitating the eradication of waitlists for opioid treatment, it represents a significant departure from the status quo and stands to produce a fundamental shift in how treatment of opioid dependence is conceptualized and delivered. The IBT components are highly novel, both individually and as an integrative interim treatment package for opioid dependence. This study will be the first to investigate the utility of IBT in th patients and settings that stand to benefit most from it. We also propose a multi-pronged dissemination approach that will ensure that our work is readily transported to clinical practice and will have a direct impact on real-world treatment of opioid dependence. Taken together, the proposed project will produce a highly innovative technology-assisted pharmacotherapy protocol that can be widely disseminated to increase access to life-saving opioid treatment. The overarching and specific aims of this proposal are directly relevant to NIDA's mission of improving the accessibility, implementation and effectiveness of drug abuse treatment.