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

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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.