Integrated Treatment for Co-Occurring Opioid Use Disorder and Posttraumatic Stress Disorder

项目摘要/摘要 拟议的以患者为导向的导师研究职业发展奖(K23)的目标是 支持Tanya Saraiya博士获得必要的技能，成为一名具有 研究方案侧重于阿片类药物使用障碍干预措施的修改和实施 精神疾病，如创伤后应激障碍(创伤后应激障碍)。高达一半的 患有创伤后应激障碍的人有创伤后应激障碍，但到目前为止，还没有建立基于证据的行为干预措施。 这同时解决了OUD和PTSD症状。拟议的研究直接针对这一重要的临床 通过测试是否通过适应、专注于创伤的综合行为来增加对OUD的药物治疗，从而实现差距 治疗物质使用障碍和共生的创伤后应激障碍(即，同时治疗创伤后应激障碍和 使用长时间暴露的物质使用障碍(COP)将改善临床结果。在目标1中，我们将 使用迭代过程修改现有的为期12周的应对措施，以应对患有OUD和PTSD的个人 由提供者和患者反馈提供信息。在目标2中，我们将进行一项开放标签试验(n=5)以进一步完善 并最终敲定治疗方案。在目标3中，我们将测试COPE结合药物治疗OUD(Moud) 对76名患有OUD和PTSD的患者进行的随机临床试验，以评估其可行性 在减少阿片类药物使用和创伤后应激障碍严重程度方面的初步疗效。在AIM 3期间，两组都将完成 生态瞬时评估(EMA)，以评估日常阿片类药物使用、渴求和创伤后应激障碍症状。EMA 将使我们能够评估日常创伤后应激障碍症状与阿片类药物渴望和使用之间的联系， 然后可以通知治疗的发展。Saraiya博士组建了一支由具有专业知识的知名导师组成的团队 在OUD、创伤后应激障碍、临床试验、OUD药物和EMA中。现场导师(苏迪·贝克博士和凯瑟琳博士 Brady)在进行行为和药物干预的临床试验方面有丰富的知识 治疗共生的物质使用障碍和创伤后应激障碍。场外导师(加州大学凯瑟琳·米尔斯博士 悉尼和NIDA的Kenzie Preston博士)将就如何修改综合干预和 利用EMA方法来扩大人口规模。建议的指导和实践培训 K23奖项将确保Saraiya博士实现以下职业目标：(1)在OUD方面拥有坚实的知识基础 和创伤后应激障碍的治疗；(2)精通临床试验的设计、评估和实施 创伤后应激障碍；(3)实施EMA的经验和纵向分析技能；(4)高级培训 负责任地进行研究；以及(5)更强的手稿和拨款写作技能。候选人将会 在南卡罗来纳医科大学完成拟议的K23活动，该大学有着良好的记录 致力于推进早期阿片类药物使用调查人员的工作。拟议的K23活动将 最终，让Saraiya博士做好准备，领导一项严格设计的OUD治疗研究计划。

PROJECT SUMMARY/ABSTRACT The objective of the proposed Mentored Patient-Oriented Research Career Development Award (K23) is to support Dr. Tanya Saraiya in acquiring the skills necessary to become an independent clinical researcher with a program of research focused on the modification and implementation of interventions for opioid use disorder (OUD) and comorbid mental health conditions, such as posttraumatic stress disorder (PTSD). Up to half of individuals with OUD have PTSD, but to date, there are no established evidence-based behavioral interventions that concurrently address OUD and PTSD symptoms. The proposed study directly addresses this major clinical gap by testing whether augmenting medications for OUD with an adapted, trauma-focused, integrated behavioral treatment for substance use disorders and co-occurring PTSD (i.e., Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure; COPE) will enhance clinical outcomes. In Aim 1, we will modify the existing 12-week, COPE intervention to individuals with OUD and PTSD using an iterative process informed by provider and patient feedback. In Aim 2, we will conduct an open-label trial (n = 5) to further refine and finalize the treatment protocol. In Aim 3, we will test COPE combined with medications for OUD (MOUD) versus MOUD-only in a randomized clinical trial among 76 individuals with OUD and PTSD to evaluate feasibility and preliminary efficacy in reducing opioid use and PTSD severity. During Aim 3, both groups will complete ecological momentary assessments (EMA) to assess for daily opioid use, craving, and PTSD symptoms. EMA will allow us to assess for the associations between daily PTSD symptoms and opioid craving and use, which may then inform treatment development. Dr. Saraiya has assembled a team of renowned mentors with expertise in OUD, PTSD, clinical trials, medications for OUD, and EMA. On-site mentors (Drs. Sudie Back and Kathleen Brady) have extensive knowledge in conducting clinical trials of behavioral and pharmacological interventions for co-occurring substance use disorders and PTSD. Off-site mentors (Dr. Katherine Mills at the University of Sydney and Dr. Kenzie Preston at NIDA) will provide guidance on how to modify the integrated intervention and leverage EMA methods to an OUD population. The mentorship and hands-on training afforded by the proposed K23 award will ensure that Dr. Saraiya achieves the following career goals: (1) a solid knowledge base in OUD and PTSD treatment; (2) proficiency in the design, evaluation, and implementation of clinical trials for OUD and PTSD; (3) experience with the implementation of EMA and skills in longitudinal analysis; (4) advanced training in the responsible conduct of research; and (5) stronger skills in manuscript and grant writing. The candidate will complete the proposed K23 activities at the Medical University of South Carolina, which has a strong track record of commitment to the advancement of early stage opioid use investigators. The proposed K23 activities will ultimately prepare Dr. Saraiya to lead a program of rigorously designed treatment research on OUD.