[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100538275":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":40,"locations":46,"responsibleParty":63,"collaborators":67,"id":71,"slug":31,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":31,"eligibilityCriteria":75,"healthyVolunteers":72,"sex":76,"minAge":77,"maxAge":31,"enrollmentInfo":78,"targetDuration":31,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":31,"overallStatus":49,"whyStopped":31,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"University of Vermont","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment as usual (TAU)","ACTIVE_COMPARATOR","Participants randomized to TAU will continue to receive standard buprenorphine or methadone maintenance treatment from their current treatment provider and complete follow-up assessments as described above. However, they will not receive posttraumatic stress disorder treatment. Staff will mail participants an emergency naloxone kit containing two naloxone doses with simple instructions, a list of resources and contact information for mental health providers and other relevant resources in their community and assistance contacting any resources of interest.",[13],"Behavioral: Treatment as usual",{"label":15,"type":16,"description":17,"interventionNames":18},"Prolonged exposure therapy (PE)","EXPERIMENTAL","In addition to receiving standard buprenorphine- or methadone-maintenance treatment from their current provider and completing scheduled assessments as described above, PE participants will also receive 12 individual sessions of prolonged exposure therapy scheduled weekly over the 12-week treatment period and delivered via a secure and university-supported telemedicine platform. Beginning in study week 1, PE participants will complete weekly 60-minute telemedicine-delivered prolonged exposure therapy sessions provided by doctoral or master's level therapists trained in prolonged exposure therapy.",[19,13],"Behavioral: Prolonged exposure therapy",{"label":21,"type":16,"description":22,"interventionNames":23},"Prolonged exposure therapy + attendance contingent financial incentives (PE+)","Participants assigned to the PE+ condition will receive the procedures noted above for the PE group plus financial incentives delivered contingent upon completion of PE sessions.",[19,24,13],"Behavioral: Financial incentives",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"BEHAVIORAL","Prolonged exposure therapy","Twelve weekly 60-minute telemedicine-delivered prolonged exposure therapy sessions provided by therapists trained in prolonged exposure therapy.",[15,21],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Financial incentives","Financial incentives contingent upon completion of prolonged exposure therapy sessions",[21],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Treatment as usual","Continued standard buprenorphine or methadone maintenance treatment from current treatment provider.",[15,21,9],[41],{"name":42,"role":43,"phone":44,"phoneExt":31,"email":45},"Kelly Peck, Ph.D.","CONTACT","8026569610","Kelly.Peck@uvm.edu",[47],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"University of Vemont","RECRUITING","Burlington","Vermont","05401","United States",{"type":55,"coordinates":56},"Point",[57,58],-73.21207,44.47588,{"lat":58,"lon":57},[61],{"name":62,"role":43,"phone":44,"phoneExt":31,"email":45},"Kelly R Peck, Ph.D.",{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Kelly Peck","Assistant Professor",[68],{"name":69,"class":70},"National Institute on Drug Abuse (NIDA)","NIH","100538275",false,"NCT06288711","Novel Telemedicine-Delivered Prolonged Exposure Therapy for Treating PTSD in Individuals With OUD","Inclusion Criteria:\n\n* \\>18 years old\n* Maintained on a stable methadone or buprenorphine dose for \\>1 month prior to the study\n* Meet current DSM-5 posttraumatic stress disorder criteria based on the Clinician Administered PTSD Scale for DSM-5\n* Participants receiving psychotropic medications must be maintained on a stable dose for \\>1 month prior to enrollment.\n\nExclusion Criteria:\n\n* Current delusions or hallucinations, unstable bipolar disorder, imminent risk for suicide as assessed by the Mini International Neuropsychiatric Interview\n* Cognitive impairment as evidenced by scores \\\u003C22 on the Videoconference-based Mini Mental Status Examination (MMSE; Folstein, et al., 1975)\n* Enrolled in another ongoing evidence-based treatment for PTSD.\n* Pregnancy as verified by pregnancy test\n* No access to cellular service","ALL","18 Years",{"count":79,"type":80},135,"ESTIMATED","INTERVENTIONAL",[83],"NA","Among individuals with opioid use disorder (OUD), posttraumatic stress disorder (PTSD) presents a significant clinical challenge. The prevalence of PTSD is substantially higher in individuals with OUD than in the general population, with nearly 90% reporting lifetime trauma exposure and 33% meeting diagnostic criteria for PTSD. The primary objective of this study is to evaluate the efficacy of a novel telemedicine-delivered prolonged exposure therapy protocol for improving PE attendance and reducing PTSD symptom severity in individuals with concurrent PTSD and OUD.",[86,87],"Opioid Use Disorder","Posttraumatic Stress Disorder","2026-05-13",{"date":90,"type":91},"2026-05-18","ACTUAL",{"date":93,"type":91},"2024-06-03",{"date":95,"type":80},"2027-11-30",{"name":5,"class":6},1]