N/A
N=52
Prolonged Exposure Therapy for PTSD and Opioid Use Disorder
Post Traumatic Stress Disorder · Opioid-use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04104022 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Change in Posttraumatic Stress Disorder (PTSD) Symptom Severity — -11.4; -12.8; -18.3 Score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Prolonged Exposure Therapy (Behavioral); Attendance-based monetary incentives (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Vermont
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Posttraumatic Stress Disorder (PTSD) Symptom Severity |
-11.4; -12.8; -18.3 | — |
| SECONDARY Posttraumatic Stress Disorder (PTSD) Symptom Severity |
31.8; 28.9; 21.7 | — |
| SECONDARY Anxiety Symptom Severity |
18.1; 15.2; 13.9 | — |
| SECONDARY Depression Symptom Severity |
22.4; 23.1; 18.6 | — |
| SECONDARY Number of Participants Achieving Illicit Opioid Abstinence |
13; 8; 14 | — |
| SECONDARY Psychiatric Problems Related to Substance Use |
0.39; 0.37; 0.33 | — |
| SECONDARY Number of Participants Who Report Abstinence From Illicit Non-opioid Substance Use |
11; 8; 13 | — |
| SECONDARY Pain Intensity and Interference |
4.9; 5.0; 4.0; 6.0; 5.0; 5.8 | — |
| SECONDARY Delay Discounting |
0.05; 0.02; 0.03 | — |
| SECONDARY Insomnia Severity |
15.0; 14.7; 13.0 | — |
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. The proposed study design will permit us to disentangle the effects of PET from the effects of OAT alone while also including experimental conditions that reflect real-world practice. Taken together, this project will produce important new scientific and clinically-relevant information related to the mechanisms through which OAT and PET promote reductions in PTSD symptomatology in a highly vulnerable clinical population.
Eligibility Criteria
Inclusion Criteria
- >18 years old
- currently maintained on a stable methadone or buprenorphine dose for >1 month prior to the study
- endorse >1 lifetime traumatic event
- meet current DSM-V posttraumatic stress disorder criteria
Exclusion Criteria
- Presence of an acute psychotic disorder, bipolar disorder with an active manic episode
- imminent risk for suicide
- a medical condition that may interfere with consent or participation
- illiteracy in English
Data sourced from ClinicalTrials.gov (NCT04104022). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.