Comprehensive CBT via reSET for a Hub and Spoke MAT System of Care

项目总结/摘要 药物辅助治疗（MAT）是国家有效应对这一流行病的基石 阿片类药物使用障碍（OUD），但缺乏行为干预和对MAT的依从性差， 实施的主要障碍。我们建议测试一个全面的认知行为的交付 治疗（CBT），reSET，以确定它是否可以改善治疗依从性，从而改善长期结果 在以社区为基础的丁丙诺啡“轴辐式”模型中， 由宾夕法尼亚州立大学米尔顿S好时医疗中心开发， 国家的资助。reSET（Pear Therapeutics，Inc）是基于网络的 治疗教育系统（TES），作为一个移动的应用程序交付，最近被FDA批准为第一个 用于治疗物质使用障碍的数字治疗辅助物。reSET基于社区 强化方法与应急管理相结合，翻译成计算机交互式 学习通过一系列的互动治疗课程，该计划教授患者认知行为 应对技巧，以抵制吸毒，并解决诸如渴望、抑郁和其他情绪问题等因素， 以及与复发风险相关的关系问题。CM组件提供具体奖励 取决于治疗依从性的关键目标行为，包括完成治疗 课程和参加诊所预约。先前的临床试验表明，测试版的reSET，TES， 在美沙酮维持患者中改善物质使用结果和/或治疗保留， 丁丙诺啡维持患者和门诊患者的物质使用障碍的混合物。 在R21阶段（R21/R33的第1年），将对reSET进行定制和试点，以确保可行性， 中心辐射系统内的可接受性，使用基于社区的前瞻性研究的原则 以及在15名OUD患者中进行的非对照试验。R33对照试验的所有基础工作（方案， 标准操作规程、CRF、数据和质量保证系统以及监管批准）将 完成在R33阶段，我们将进行患者水平的6个月随机对照有效性研究 试验中，200例OUD患者在宾夕法尼亚州立大学中心和辐条内使用丁丙诺啡启动MAT 将获得知情同意并随机分配至中心辐射式内的常规治疗（TAU）或TAU 再加上认知行为干预（TAU+reSET）。主要结局指标将是 丁丙诺啡治疗保持6个月，次要结局将包括尿液证实的 禁欲，以及应对技能，社会功能，情绪和艾滋病毒风险的改善， 重置.如果发现在支持MAT方面有效，那么作为一个移动的应用程序，reSET有可能迅速 在整个美国卫生系统中传播，以支持STR倡议。

Project Summary / Abstract Medication assisted treatment (MAT) is a cornerstone of an effective national response to the epidemic of opioid use disorder (OUD), but lack of access to behavioral interventions and poor adherence to MAT are key barriers to implementation. We propose to test the delivery of a comprehensive cognitive behavioral therapy (CBT), reSET, to determine whether it can improve treatment adherence and thus long term outcome among patients with OUD initiating MAT within a community-based "Hub and Spoke” Model of buprenorphine maintenance in central Pennsylvania, developed by the Penn State Milton S Hershey Medical Center with STR funding from the State. reSET (Pear Therapeutics, Inc), is a commercially available version of the web-based Therapeutic Education System (TES), delivered as a mobile app and recently approved by the FDA as the first digital therapeutic adjunct for the treatment of substance use disorders. reSET is based on the Community Reinforcement Approach combined with Contingency Management, translated into computer-interactive learning. Through a series of interactive therapy lessons, the program teaches patients cognitive-behavioral coping skills to resist drug use and to address factors such as craving, depression and other mood problems, and relationship issues that are associated with risk of relapse. The CM component provides concrete rewards contingent on performance of key target behaviors of treatment adherence, including completing the therapy lessons and attending clinic appointments. Prior clinical trials show that the beta version of reSET, TES, improved substance use outcome and/or treatment retention among methadone maintained patients, buprenorphine maintained patients, and outpatients with a mixture of substance use disorders. In the R21 phase (Year 1 of this R21/R33) reSET will be tailored and piloted for feasibility and acceptability within the Hub and Spoke system, using principles of Community-Based Participatory Research and an uncontrolled pilot trial in 15 OUD patients. All groundwork for the R33 controlled trial (protocol, standard operating procedures, CRFs, data and quality assurance systems, and regulatory approvals) will be completed. In the R33 phase we will conduct a patient-level, 6 month randomized controlled effectiveness trial, in which 200 patients with OUD initiating MAT with buprenorphine within the Penn State Hub and Spoke will be consented and randomly assigned to either treatment as usual (TAU) within the Hub and Spoke, or TAU plus the cognitive-behavioral intervention reSET (TAU+reSET). The primary outcome measure will be retention on buprenorphine treatment for 6 months, and secondary outcomes will include urine-confirmed abstinence, and improvements in coping skills, social functioning, mood, and HIV risk that are targeted by reSET. If found effective in supporting MAT, reSET, as a mobile app, has the potential to be rapidly disseminated across the U.S. health system in support of the STR initiative.