Enhanced treatment management of opioid-dependence in an office-based setting

描述(由申请人提供)：阿片类药物的滥用和误用已经是一个严重的医疗问题，预计在未来十年将急剧升级。传统上，阿片依赖的治疗是在特殊护理环境中提供的，例如住宅治疗社区、美沙酮维持诊所以及专门的住院或门诊治疗方案，然而这些特殊护理设施的可用性 没有跟上需求的步伐。因此，令人震惊的是，80%的阿片依赖者目前在美国仍然没有得到治疗。政策制定者试图解决这一治疗缺口的一种方式是批准在办公室工作的医生提供丁丙诺啡疗法。虽然这种治疗方式被证明总体上是安全有效的，但其潜力仍未得到充分发挥，因为只有一小部分医生利用了这一机会。提出的理由包括对患者可能滥用和/或误用药物的担忧，与向成瘾患者群体提供治疗相关的密集要求，以及遵守DEA关于开出受控物质的繁重要求所涉及的额外努力和法律责任。为了解决这个问题，我们建议开发和测试BupreCare，这是一种全面的治疗管理解决方案，用于在办公室环境中向阿片依赖者提供药物辅助治疗(MAT)。BupreCare将围绕三个主要组成部分展开--预装丁丙诺啡/纳洛酮通用配方的专用配药装置(DDD)，它通过有限使用的通行码控制药物的使用；患者用来获得这些通行码并报告治疗状态的网络/电话(IVR)患者门户；以及提供者用来设置治疗参数和监测患者进展的基于网络的行政门户。第一阶段的开发工作将集中在BupreCare诱导套件(BIK)的开发和测试上，患者和提供者可以使用它来促进安全和方便的诱导体验。为此，高保真的“看起来像、像工作一样”的物理 BIK的原型将在可用性测试期间进行迭代提炼，然后用于试点 将使用BIK的患者的诱导体验与接受常规治疗(TAU)的患者进行比较的研究。令人感兴趣的结果指标将包括1周时阿片类药物的使用情况，以及治疗成本、阿片类药物渴望、症状严重程度和治疗满意度。患者和提供者的接受度也将作为接受度研究的一部分进行衡量。最后，第二阶段的剩余研发任务、商业化计划和现场试验设计也将完成。 与公共卫生相关：阿片类药物的使用和滥用是一个严重的医疗问题，每年给美国造成超过3000亿美元的损失。然而，绝大多数阿片依赖者仍然没有得到治疗，尽管可以通过他们自己的私人医生为他们提供有效的药物治疗，如丁丙诺啡。这项研究将开发和测试一种低成本的治疗管理解决方案，旨在提高阿片类药物治疗的实用性、安全性和有效性 当医生在办公室环境中提供治疗时，更容易获得依赖，从而使更多的患者更容易获得治疗。

DESCRIPTION (provided by applicant): The abuse and misuse of opiods is already a significant healthcare problem that is expected to escalate dramatically in the next decade. Traditionally, the treatment of opioid-dependence has been provided in specialty care settings, such as residential therapeutic communities, methadone maintenance clinics, and dedicated inpatient or outpatient treatment programs, yet the availability of these specialty care facilities has not kept pace with demand. As a result, an astounding 80% of opioid-dependent persons currently remain untreated in the U.S. One way policy makers have tried to address this treatment gap is by sanctioning delivery of Buprenorphine therapies by physicians working in office-based environments. Although shown to be generally safe and effective, the potential of this treatment modality remains unfulfilled, as only a small percentage of physicians have taken advantage of this opportunity. The reasons cited for this include concern about possible patient abuse and/or misuse of the drug, the intensive demands associated with providing treatment to a population of addicted patients, and the additional effort and legal liabilities involved in complying with burdensome DEA requirements for prescribing controlled substances. To address this problem, we propose the development and testing of BupreCare, a comprehensive treatment management solution for delivering Medication Assisted Therapy (MAT) to opioid-dependent persons in an office based setting. BupreCare will be centered around three primary components - a specialized drug dispensing device (DDD) pre-loaded with a generic formulation of buprenorphine/naloxone that controls access to medications via limited-use pass codes, a web/phone (IVR) patient portal patients use to obtain these pass codes and report on treatment status, and a web-based administrative portal providers use to setup treatment parameters and monitor patient progress. Phase I development efforts will focus on the development and testing of the BupreCare Induction Kit (BIK), which patients and providers can use to facilitate a safe and convenient induction experience. To this end, a high fidelity "looks-like, works-like" physical prototype of the BIK will be iteratively refined during usability testing, and then used in a pilot study in which the induction experience of patients using BIK is compared to those receiving treatment as usual (TAU). Outcome measures of interest will include opioid usage at 1-week, as well as treatment cost, opioid cravings, symptom severity, and treatment satisfaction. Patient and provider acceptance will also be measured as part of an acceptance study. Finally, the remaining research and development tasks, commercialization plan, and field trial design proposed for Phase II will also be completed. PUBLIC HEALTH RELEVANCE: The use and abuse of opioids is a significant healthcare problem costing the U.S. upwards of $300 billion annually. However, the vast majority of opiod dependent persons remain untreated for the disorder, even though effective medication therapies, such as Buprenorphine, could be made available to them through their own personal physician. This research will develop and test a low-cost treatment management solution designed to increase the practicality, safety, and effectiveness of medication therapies for opioid dependence when delivered by physicians working in an office-based environment, thereby making the treatment more readily available to larger segments of the patient population.