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

PROJECT SUMMARY/ABSTRACT The objective of this K23 administrative supplement is to request support following the impending critical life event of childbirth. I was awarded this NIDA K23 in August 2022. During the first three years of this award, I hired and trained research assistants and graduate-level study therapists. However, given budgetary constraints, I am only able to pay for 8 hours a week of my current research assistant’s time, which is exclusively focused on recruitment and completing baseline visits to assess eligibility in our ongoing randomized clinical trial. The K23 project had the following specific aims: In Aim 1, we modified the existing trauma-focused integrated psychotherapy intervention to individuals with co-occurring opioid use disorder and posttraumatic stress disorder (OUD/PTSD) using mixed methods feedback from interviews with provider and patients. In Aim 2, we conducted an open-label trial to assess feasibility and further refine the treatment protocol among six eligible individuals. In Aim 3, we are actively testing the new intervention—Helping Opioid Use Disorder and PTSD with Exposure [HOPE]—combined with medications for OUD (MOUD) versus a MOUD-only control group in a randomized clinical trial among 76 individuals with OUD/PTSD to evaluate feasibility and preliminary efficacy in reducing opioid use and PTSD severity. During Aim 3, both groups are also completing ecological momentary assessments to assess for daily opioid use, craving, and PTSD symptoms. I have made significant progress on my K23 project, including completing the first two specific aims; submitting findings from both aims for peer- reviewed publication; completing relevant trainings, fellowships, and didactics; and publishing 16 co-authored manuscripts since the receipt of this award. Moreover, I have launched the randomized clinical trial and have enrolled 2 out of the 76 participants. Despite my progress on my K23 goals, study progress will be significantly interrupted by my upcoming parental leave. Therefore, the purpose of this K23 administrative supplement is to request funding for me to hire full-time personnel to assist with the execution of the project in addition to cover the effort of faculty investigators who may manage the clinical trial and clinically supervise study therapists and patients actively enrolled in the trial while I’m on leave. The research assistant and faculty supervisors will assist with my current duties on my K23 and will oversee active patients, supervise study therapists, and enroll new patients into the study. In addition, these individuals will assist with data management and cleaning so that I will be on track to submit my first R01 application as contact PI in the next year. Upon the completion of my parental leave, I will return to full productivity and execute the study aims with the long-term goal of becoming an independent investigator in the field of addiction science and co-occurring mental health conditions.