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NCT04104022 · ClinicalTrials.gov registry record · NA
Prolonged Exposure Therapy for PTSD and Opioid Use Disorder
A NA study, sponsored by University of Vermont.
- Completed
- Registry status
- NA
- Development phase
- 82
- Enrollment target
NCT04104022 is a NA study that has completed, run by University of Vermont. The registered enrollment target is 82 participants.
The verdict
NCT04104022, a NA study, has completed, sponsored by University of Vermont.
- COMPLETED
- Registry status
- NA
- Development phase
- 82 participants
- Enrollment target
Study Summary
Among patients with opioid use disorder (OUD), 90% report lifetime trauma exposure and 33% meet criteria for posttraumatic stress disorder (PTSD). The co-occurrence of OUD and PTSD is associated with worse mental health and opioid agonist treatment (OAT) outcomes relative to either diagnosis alone. Prolonged exposure therapy (PET) is an efficacious cognitive-behavioral treatment for reducing PTSD severity. Although preliminary findings indicate that PET may reduce PTSD symptom severity among patients receiving treatment for concomitant OUD, it is unclear to what extent improvements were a function of PET versus the effects of OAT itself. Therefore, the question of whether OAT alone may attenuate PTSD symptoms in the absence of intensive cognitive-behavioral therapy remains unanswered. In this 12-week trial, we aim to investigate the contribution of PET above and beyond OAT alone for reducing PTSD symptoms among adults with concurrent PTSD and OUD. Participants will be randomized to one of three conditions: (a) OAT as usual, (b) OAT + PET, or (c) OAT + Enhanced PET (OAT+PET+). Those randomized to OAT as usual will continue to receive standard buprenorphine or methadone treatment from their current treatment provider and complete assessments of PTSD symptom severity, psychosocial functioning and drug use at intake and Study Weeks 4, 8, and 12. In addition to receiving OAT and completing monthly assessments, OAT+PET participants will receive PET consisting of 12 weekly, individual sessions with a trained therapist. Finally, OAT+PET+ participants will receive the procedures noted above for the OAT+PET group plus monetary incentives delivered contingent upon completion of PET sessions. Given the poor PET adherence rates reported among patients with substance use disorders, the use of incentives will ensure that we evaluate PET effects among patients who receive a sufficient dose of therapy. Prior to conducting the randomized trial, we will recruit and enroll participan
Interventions
- BEHAVIORAL Prolonged Exposure Therapy
- BEHAVIORAL Attendance-based monetary incentives
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2019-11-08 |
| Est. Completion | 2023-07-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04104022
The ClinicalTrials.gov registry entry for NCT04104022 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 82 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Vermont, which has 162 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Prolonged Exposure Therapy is the first listed.
NCT04104022 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04104022 about?
NCT04104022 is a clinical study titled "Prolonged Exposure Therapy for PTSD and Opioid Use Disorder". Among patients with opioid use disorder (OUD), 90% report lifetime trauma exposure and 33% meet criteria for posttraumatic stress disorder (PTSD). The co-occurrence of OUD and PTSD is associated with worse mental health and opioid agonist treatment (OAT) outcomes relative to either diagnosis alone. ...
What is the current status of trial NCT04104022?
This trial is currently completed. It is a NA study. The enrollment target is 82 participants. The study started on 2019-11-08. Estimated completion is 2023-07-31.
What interventions are being tested in trial NCT04104022?
The interventions under investigation include: Prolonged Exposure Therapy (BEHAVIORAL), Attendance-based monetary incentives (BEHAVIORAL).
Who is sponsoring clinical trial NCT04104022?
This trial is sponsored by University of Vermont, which has 162 total clinical trials registered on ClinicalTrials.gov.
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