[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06641115":3,"trial-entities:NCT06641115":97,"trial-summary:NCT06641115":101},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":41,"secondary_outcomes":49,"sex":50,"minimum_age":51,"maximum_age":52,"healthy_volunteers":53,"eligibility_criteria":54,"std_ages":69,"locations":72,"central_contacts":87,"overall_officials":91,"references":95,"see_also_links":96},"NCT06641115","Pro00138487","Integrated Treatment for Opioid Use Disorder and PTSD","Integrated Treatment for Co-Occurring Opioid Use Disorder and Posttraumatic Stress Disorder","RECRUITING","2027-08","2025-11","2025-11-28","2025-03-01","Medical University of South Carolina","OTHER",true,"This study will test a therapy intervention, HOPE, for individuals with opioid use disorder and posttraumatic stress disorder. Interested individuals will need to be taking medications for opioid use disorder (e.g., suboxone, naltrexone, methadone). Interested participants will complete a 10-12 week therapy, and be asked to complete surveys.","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 by testing an adapted, trauma-focused, integrated behavioral treatment for substance use disorders and co-occurring PTSD (i.e., Helping Opioid Use and PTSD with Exposure; HOPE) will enhance clinical outcomes. The investigators will test HOPE 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. Both conditions will also complete ecological momentary assessments (EMA) to assess for daily opioid use, craving, and PTSD symptoms. EMA will allow for the assessment of the associations between daily PTSD symptoms and opioid craving and use, which may then inform treatment development.",[19,20],"Opioid Use Disorder","Posttraumatic Stress Disorder (PTSD)",[22,23,24,25,26,27],"Mental Health","Psychiatry","Substance Use","PTSD","Opioid Use","Therapy","INTERVENTIONAL","TREATMENT",[31],"NA",{"count":33,"type":34},76,"ESTIMATED",[36],{"type":37,"name":38,"description":39,"armGroupLabels":40},"BEHAVIORAL","HOPE Therapy","Helping Opioid Use and PTSD with Exposure (HOPE) therapy is an integrated 10-12 week treatment for opioid use disorder and trauma\u002Fposttraumatic stress disorder",[38],[42,46],{"measure":43,"description":44,"timeFrame":45},"Change in Opioid Use","Opioid use (percent days using) as measured by urine drug screens","through study treatment completion, an average of 12 weeks",{"measure":47,"description":48,"timeFrame":45},"Change in Posttraumatic Stress Disorder Symptoms","Posttraumatic Stress Disorder symptoms as measured by the Clinician Administered Posttraumatic Stress Disorder Scale for the Diagnostic and Statistical Manual for Mental Disorders, 5th Edition or the CAPS-5. Total severity scores on this measure range from 0-80 with higher scores denoting more severe posttraumatic stress disorder symptoms.",[],"ALL","18 Years","70 Years",false,{"inclusion":55,"exclusion":62,"raw_text":68},[56,57,58,59,60,61],"Any gender; any race or ethnicity; aged 18-70 years old.","English-speaking","Meet DSM-5 diagnostic criteria for OUD.","Meet DSM-5 diagnostic criteria for PTSD and have some memory of their index traumatic event.","Must be maintained on a stable dose of medication for OUD for at least 1 month.","Participants taking psychotropic medications will be required to be maintained on a stable dose for at least 1 month before study initiation.",[63,64,65,66,67],"Participants presenting with psychiatric contraindications (e.g., unmanaged psychosis or mania, or bipolar) will be excluded and referred clinically.","Participants considered an immediate suicide risk, with current suicidal ideation and a plan of intent, or displaying other high-risk behaviors (i.e., MOUD refusal, risky fentanyl use, etc.), as determined by the PI and study team. These individuals will complete a safety plan and be referred for treatment.","Participants meeting DSM-5 criteria for a concurrent, non-opioid, substance use disorder and who report that the other substance is their primary substance of use. These participants will be referred clinically for treatment.","Participants enrolled in ongoing evidence-based psychotherapy for substance use disorders or PTSD outside of medications for OUD and standard psychotherapy groups in treatment programs.","Medical problems requiring immediate and intensive treatment, such as unstable or symptomatic end stage liver disease.","Inclusion Criteria:\n\n* Any gender; any race or ethnicity; aged 18-70 years old.\n* English-speaking\n* Meet DSM-5 diagnostic criteria for OUD.\n* Meet DSM-5 diagnostic criteria for PTSD and have some memory of their index traumatic event.\n* Must be maintained on a stable dose of medication for OUD for at least 1 month.\n* Participants taking psychotropic medications will be required to be maintained on a stable dose for at least 1 month before study initiation.\n\nExclusion Criteria:\n\n* Participants presenting with psychiatric contraindications (e.g., unmanaged psychosis or mania, or bipolar) will be excluded and referred clinically.\n* Participants considered an immediate suicide risk, with current suicidal ideation and a plan of intent, or displaying other high-risk behaviors (i.e., MOUD refusal, risky fentanyl use, etc.), as determined by the PI and study team. These individuals will complete a safety plan and be referred for treatment.\n* Participants meeting DSM-5 criteria for a concurrent, non-opioid, substance use disorder and who report that the other substance is their primary substance of use. These participants will be referred clinically for treatment.\n* Participants enrolled in ongoing evidence-based psychotherapy for substance use disorders or PTSD outside of medications for OUD and standard psychotherapy groups in treatment programs.\n* Medical problems requiring immediate and intensive treatment, such as unstable or symptomatic end stage liver disease.",[70,71],"ADULT","OLDER_ADULT",[73],{"facility":13,"status":8,"city":74,"state":75,"zip":76,"country":77,"contacts":78,"geoPoint":84},"Charleston","South Carolina","29403","United States",[79],{"name":80,"role":81,"phone":82,"email":83},"Tanya C Saraiya, PhD","CONTACT","8438762374","saraiya@musc.edu",{"lat":85,"lon":86},32.77632,-79.93275,[88],{"name":89,"role":81,"phone":82,"email":90},"Tanya C Saraiya, Ph.D.","saraiya@musce.edu",[92],{"name":93,"affiliation":13,"role":94},"Tanya Saraiya, PhD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":98,"biomarkers":100},[19,99],"Post-Traumatic Stress Disorder",[],{"nct_id":4,"found":15,"summary":102,"prompt_version":111},{"design":103,"status":104,"heading":6,"summary":105,"follow_up":106,"word_count":107,"commitments":108,"compensation":109,"drugs_mentioned":110},"This is an interventional study that will enroll 76 participants. It will compare HOPE therapy plus medication for OUD against medication for OUD alone.","completed","This study is testing a new therapy called HOPE (Helping Opioid Use and PTSD with Exposure) for people who have both opioid use disorder (OUD) and posttraumatic stress disorder (PTSD). HOPE therapy is a 10-12 week program designed to address both conditions at the same time. You can join if you are 18-70 years old, speak English, and are already taking stable medication for your opioid use disorder (like suboxone, naltrexone, or methadone). The researchers want to see if HOPE therapy, combined with your current medication, can help reduce opioid use and PTSD symptoms. This study aims to enroll 76 participants, but its current recruitment status is unclear.","The primary outcomes, such as changes in opioid use and PTSD symptoms, will be measured through study treatment completion, which is an average of 12 weeks.",108,"You would complete a 10-12 week therapy program and fill out surveys. You will also complete daily assessments on your phone about opioid use, cravings, and PTSD symptoms.","Not stated in the trial record.",[38],"v2"]