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）：尽管激动剂维持治疗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治疗名额等候名单。患者可能会在这些候补名单上停留多年，从而使他们在此期间面临非法药物使用、犯罪活动、传染病、服药过量和死亡的较高风险。这些治疗获取的延迟是广泛提供有效阿片类药物治疗的重大障碍，迫切需要开发创造性的新方法来缓解这些延迟。我们在此应用中的首要目标是开发一种新型临时丁丙诺啡治疗 (IBT)，以弥补治疗延迟。我们的综合治疗方案包括五个关键组成部分，每个组成部分都经过战略选择，以最大限度地提高患者获得阿片类药物依赖药物治疗的机会，同时最大限度地减少不依从、滥用和转移：丁丙诺啡、计算机化依从性监测、通过交互式语音应答提供的移动健康临床支持、用于尿液分析和依从性监测的自动随机回叫以及通过 iPad 提供的 HIV+肝炎教育。这一阶段 I 行为和综合治疗开发申请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，其中 70 名等待激动剂维持的阿片类药物依赖成年人被随机分配接受 IBT (n=35) 或继续处于候补名单控制条件 (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数据来评估 IBT 干预的效果。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候补名单，它代表着与现状的重大背离，并将在阿片类药物依赖治疗的概念化和实施方式方面产生根本性转变。 IBT 成分无论是单独使用还是作为阿片类药物依赖的综合临时治疗方案都非常新颖。这项研究将是第一个调查 IBT 在患者和从中受益最大的环境中的效用的研究。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轻松转移到临床实践，并对阿片类药物依赖的现实治疗产生直接影响。总而言之，拟议的项目将产生一种高度创新的技术辅助药物治疗方案，该方案可以广泛传播，以增加获得挽救生命的阿片类药物治疗的机会。该提案的总体和具体目标与 NIDA 改善药物滥用治疗的可及性、实施和有效性的使命直接相关。