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

并发阿片类药物使用障碍和创伤后应激障碍的综合治疗

基本信息

批准号：
10524647
负责人：
Tanya Chandresh Saraiya
金额：
$ 20.07万
依托单位：
RUTGERS, THE STATE UNIV OF N.J.
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-09-15 至 2027-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10524647
关键词：
Address Adult Affect Aftercare American Back Behavior Therapy Behavioral Biological Chronic Post Traumatic Stress Disorder Clinical Clinical Trials Cognitive Therapy Combined Modality Therapy Complex Conduct Clinical Trials DSM-V Data Development Ecological momentary assessment Ensure Evaluation Evidence based treatment FDA approved Feedback Feeling suicidal Focus Groups Future Goals Grant Health Care Costs Health Expenditures Helping to End Addiction Long-term Individual Intervention Knowledge Lead Manuscripts Measures Medical Mental Depression Mental Health Mentored Patient-Oriented Research Career Development Award Mentors Mentorship Methods Modification Moods National Institute of Drug Abuse Opioid Outcome Overdose Pain Participant Patients Pharmaceutical Preparations Pharmacotherapy Population Post-Traumatic Stress Disorders Process Provider Public Health Randomized Randomized Clinical Trials Research Research Personnel Research Training Risk Factors Severities Site Solid South Carolina Standardization Strategic Planning Substance Use Disorder Symptoms Testing Time Training Trauma Treatment Efficacy Treatment Protocols Treatment outcome United States National Institutes of Health Universities Writing addiction behavioral clinical trial behavioral pharmacology career career development chronic pain clinical care clinical practice clinical trial implementation comorbidity craving design effective intervention effective therapy efficacious intervention evidence base experience feasibility testing healing implementation intervention improved innovation intervention effect knowledge base longitudinal analysis medication compliance open label opioid overdose opioid use opioid use disorder overdose death overdose risk patient oriented physical conditioning programs psychiatric comorbidity responsible research conduct secondary outcome service providers skills substance use therapy design therapy development time use treatment research

项目摘要

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.

项目概要/摘要拟议的以患者为导向的研究职业发展奖（K23）的目标是支持 Tanya Saraiya 博士获得成为一名独立临床研究员所需的技能研究计划侧重于阿片类药物使用障碍干预措施的修改和实施 (OUD) 和共病心理健康状况，例如创伤后应激障碍 (PTSD)。最多一半患有 OUD 的人患有 PTSD，但迄今为止，还没有既定的基于证据的行为干预措施同时解决 OUD 和 PTSD 症状。拟议的研究直接解决这一重大临床问题通过测试是否通过适应的、针对创伤的、综合的行为来增强 OUD 药物治疗的差距治疗物质使用障碍和同时发生的 PTSD（即同时治疗 PTSD 和长时间接触药物导致药物滥用； COPE）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针对 OUD 和 PTSD 患者的 12 周 COPE 干预措施由提供者和患者的反馈通知。在目标 2 中，我们将进行开放标签试验（n = 5）以进一步完善并最终确定治疗方案。在目标 3 中，我们将测试 COPE 与 OUD 药物 (MOUD) 的结合在一项对 76 名 OUD 和 PTSD 患者进行的随机临床试验中与仅 MOUD 进行比较，以评估可行性以及减少阿片类药物使用和 PTSD 严重程度的初步功效。在目标 3 期间，两组都将完成生态瞬时评估 (EMA)，用于评估日常阿片类药物的使用、渴望和 PTSD 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，这然后可以为治疗的发展提供信息。 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 OUD、PTSD、临床试验、OUD 药物和 EMA。现场导师（Sudie Back博士和Kathleen博士） Brady）在进行行为和药物干预临床试验方面拥有丰富的知识用于同时发生的物质使用障碍和创伤后应激障碍 (PTSD)。场外导师（英国大学 Katherine Mills 博士） Sydney 和 NIDA 的 Kenzie Preston 博士）将就如何修改综合干预措施和利用 EMA 方法来处理 OUD 群体。拟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) 扎实的 OUD 知识基础和创伤后应激障碍（PTSD）治疗； (2) 熟练掌握OUD和临床试验的设计、评估和实施创伤后应激障碍； (3) EMA实施经验和纵向分析技能； (四)进修培训负责任地进行研究；（5）更强的稿件和资助写作技巧。候选人将在拥有良好记录的南卡罗来纳医科大学完成拟议的 K23 活动致力于推动早期阿片类药物使用调查人员的发展。拟议的 K23 活动将最终让 Saraiya 博士做好领导一项严格设计的 OUD 治疗研究计划的准备。