Interim Treatment: Leveraging buprenophine + technology to bridge waitlist delays

临时治疗：利用丁丙诺啡技术来弥补等候名单的延误

• 批准号: 8825482
• 负责人: STACEY C SIGMON
• 金额: $ 32.6万
• 依托单位: UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-04-01 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8825482
• 关键词: Abstinence; Adherence; Adult; Agonist; Back; Behavioral; Buprenorphine; Clinic; Clinic Visits; Clinical; Communicable Diseases; Communication; Counseling; Data; Devices; Dose; Drug abuse; Drug usage; Education; Effectiveness; Emergency Situation; Enrollment; Ensure; Feedback; Frequencies; Genetic Crossing Over; Goals; HIV; Health; Hepatitis; Hour; Illicit Drugs; Individual; Intervention; Knowledge; Licensing; Life; Logic; Maintenance; Manuals; Medical; Methadone; Methodology; Methods; Mission; Modeling; Monitor; Opiate Addiction; Opioid; Overdose; Participant; Patient Monitoring; Patients; Persons; Pharmaceutical Preparations; Pharmacotherapy; Privacy; Procedures; Protocols documentation; Provider; Randomized; Regulation; Research; Resources; Risk; Schedule; Services; Specimen; Staging; System; Technology; Telephone; Time; Urinalysis; Urine; Visit; Voice; Waiting Lists; Work; base; clinical practice; computerized; cost; follow-up; improved; innovation; innovative technologies; mHealth; medical specialties; medication compliance; meetings; monitoring device; mortality; novel; novel strategies; portability; programs; randomized trial; response; rural area; therapy development

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.

描述（由申请人提供）：尽管激动剂维护对治疗阿片类药物依赖的有效性无可争议，但目前的能力在美国和国际上不足以满足需求。确实，令人震惊的诊所数量有广泛的候补名单来治疗插槽。患者可以在这些候补名单上保留这些候补名单，使他们处于这种疾病期间非法药物使用，犯罪活动，传染病，过量和死亡率的较高风险。这些治疗访问的延迟是广泛提供有效阿片类药物治疗的重大障碍，并且迫切需要开发创造性的新方法来减轻这些延迟。我们在本应用程序中的总体目标是开发一种新型的临时丁丙诺啡治疗（IBT），该治疗可以弥合治疗访问的延迟。我们的综合治疗套餐包括五个关键组成部分，每个关键组成部分是为了最大程度地选择患者获得阿片类药物依赖性药物疗法的机会，同时最大程度地减少了不遵守，滥用和转移：丁丙诺啡，计算机化的依从性监测，MHealth临床支持，通过交互式语音反应提供的互动式呼叫响应，自动化的呼叫呼叫，自动呼叫，以通过尿液分析和依从性监控和HEPATITIS和HEPATITIS和HEPATITIT和HEPATITIT和HEPATITIT和HEPATITIS和HEPATITIS进行ipation和Hepatiation和HEPATITIT和HEPATITIS和HEPATITIS和HEPATITIS。该阶段I行为和综合治疗开发应用的主要目的是评估IBT在为期12周的随机试验中IBT的可行性和初始功效，其中70名阿片类药物依赖性成年人等待着激动剂维持的成年人被随机分配以接收IBT（n = 35）（n = 35）或在候补控制条件下继续（wlc; n = 35）。在第12周没有进入治疗的WLC参与者当时将有机会跨越IBT，从而贡献其他受试者数据，以评估IBT干预的功效。拟议的研究以几种重要的方式具有创新性：通过促进阿片类药物治疗的候补名单的根除，它与现状相去甚远，并且可以对阿片类药物依赖的治疗方法进行概念化和交付的方式产生根本性的转变。 IBT组件是高度新颖的，无论是单独还是作为阿片类药物依赖性的综合临时治疗套件。这项研究将是第一个研究IBT在TH患者和设置中受益最大的IBT效用的研究。我们还提出了一种多管齐下的传播方法，该方法将确保我们的工作很容易将其运送到临床实践，并将直接影响阿片类药物依赖性的现实世界治疗。综上所述，拟议的项目将产生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救生的阿片类药物治疗的机会。该提案的总体和具体目的与NIDA的使命直接相关，即改善药物滥用治疗的可及性，实施和有效性。