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

项目总结/摘要 建议的指导病人为导向的研究职业发展奖（K23）的目的是 支持Tanya Saraiya博士获得成为独立临床研究员所需的技能， 一项研究计划，重点是阿片类药物使用障碍干预措施的修改和实施 (OUD)和共病的心理健康状况，如创伤后应激障碍（PTSD）。多达一半 OUD患者患有PTSD，但到目前为止，还没有建立基于证据的行为干预措施 能同时解决OUD和PTSD症状这项研究直接针对这一重大临床问题， 通过测试是否用适应性的、以创伤为重点的、综合的行为疗法来增加OUD的药物治疗， 治疗物质使用障碍和共同发生的PTSD（即，PTSD的并发治疗和 长期接触物质使用障碍（科普）将提高临床结果。在目标1中，我们 使用迭代过程修改现有的12周科普干预，以治疗OUD和PTSD患者 由提供者和患者反馈告知。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 最后敲定治疗方案在目标3中，我们将测试科普联合药物治疗OUD（MOUD） 在76名OUD和PTSD患者中进行的随机临床试验中， 以及减少阿片类药物使用和PTSD严重程度的初步疗效。在目标3期间，两组都将完成 生态瞬时评估（EMA），以评估每日阿片类药物使用，渴望和创伤后应激障碍症状。EMA 将使我们能够评估日常PTSD症状与阿片类药物渴望和使用之间的关联， 然后可以告知治疗开发。Saraiya博士组建了一个由知名导师组成的团队， OUD，PTSD，临床试验，OUD药物和EMA。现场导师（Sudie Back博士和Kathleen博士 布雷迪）在进行行为和药物干预的临床试验方面具有广泛的知识 药物滥用和创伤后应激障碍场外导师（密歇根大学的凯瑟琳米尔斯博士） Sydney和NIDA的Kenzie普雷斯顿博士）将提供如何修改综合干预措施的指导， 将EMA方法用于OUD人群。拟议的方案提供的指导和实践培训 K23奖将确保Saraiya博士实现以下职业目标：（1）在OUD方面的坚实知识基础 和PTSD治疗;（2）熟练设计，评估和实施OUD临床试验， 创伤后应激障碍;（3）EMA实施经验和纵向分析技能;（4）高级培训 在负责任的研究行为;和（5）更强的技能，在手稿和赠款写作。候选人将 完成南卡罗来纳州医科大学拟议的K23活动，该大学有着良好的业绩记录 致力于推进早期阿片类药物使用调查。K23项目将 最终让Saraiya博士做好领导一项严格设计的OUD治疗研究计划的准备。

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.