Prolonged Exposure Therapy for PTSD and Opioid Use Disorder

NCT04104022 | Completed Results

• 2 other identifiers: CHRBSS #STUDY00000318P20GM103644
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post Traumatic Stress Disorder; Opioid-use Disorder

Keywords

Post Traumatic Stress Disorder; Opioid-use Disorder; Prolonged Exposure Therapy; Opioid Agonist Therapy; Financial Incentives; Substance Use

Outcome Measures

Primary Outcomes (1)

• Change in Posttraumatic Stress Disorder (PTSD) Symptom Severity

  Change in PTSD symptom severity will be measured by the total symptom severity score of the Clinician Administered PTSD Scale for DSM-V (CAPS-5). The CAPS-5 is a clinician-administered clinical interview that produces a total symptom severity score that is obtained by summing the scores for each of the 20 items. Scores range from 0-80 with lower scores indicating less severe symptoms of PTSD. A negative sign in front of a number represents a decrease in score and less severe PTSD symptoms at 12 weeks compared to baseline. A greater decrease in score represents greater reduction in symptoms (more positive outcomes).

  12 weeks

Secondary Outcomes (9)

• Posttraumatic Stress Disorder (PTSD) Symptom Severity

  12 weeks

• Anxiety Symptom Severity

  12 weeks

• Depression Symptom Severity

  12 weeks

• Number of Participants Achieving Illicit Opioid Abstinence

  12 weeks

• Psychiatric Problems Related to Substance Use

  12 weeks

Study Arms (3)

OAT as usual

NO INTERVENTION

Those randomized to OAT as usual will continue to receive standard buprenorphine or methadone treatment and complete assessments of PTSD symptom severity, psychosocial functioning and drug use at intake and Study Weeks 4, 8, and 12.

OAT+PET

ACTIVE COMPARATOR

In addition to receiving OAT and completing monthly assessments, OAT+PET participants will receive 12 weekly PET sessions with a trained therapist.

Behavioral: Prolonged Exposure Therapy

OAT+PET+

EXPERIMENTAL

OAT+PET+ participants will receive the procedures for the OAT+PET group plus monetary incentives contingent upon completion of PET sessions

Behavioral: Prolonged Exposure Therapy; Behavioral: Attendance-based monetary incentives

Interventions

Prolonged Exposure Therapy BEHAVIORAL

Within the general population, prolonged exposure therapy (PET) is a widely-used, empirically-supported and manualized therapy that is regarded as a first-line cognitive-behavioral treatment for posttraumatic stress disorder (PTSD). PET is designed to disrupt the cycle of anxiety and avoidance that characterizes PTSD via sustained imaginal and in-vivo exposure exercises that deliberately and systematically expose patients to painful memories and current, real-life trauma reminders that were previously avoided, yet not inherently harmful. Overall, PET has well-documented efficacy for reducing PTSD symptom severity in both civilian and veteran populations. PET is effective for reducing PTSD symptoms regardless of whether it is delivered remotely or face-to-face. Recent data also suggest that PET can improve PTSD symptoms without exacerbating substance use or craving among patients with substance use disorders when PET and substance use disorder treatment are delivered concurrently.

OAT+PET; OAT+PET+

Attendance-based monetary incentives BEHAVIORAL

Participants will earn vouchers that have monetary value for attending scheduled PET appointments. Each consecutive attended session will increase the voucher amount so that each consecutively attended appointment is worth an incrementally higher dollar amount. To support completion of the full 12-week PET protocol, we will also incorporate additional strategically-placed bonuses into the reinforcement schedule with the goal of maximizing the percentage of subjects who complete the full 12-session protocol. First, to support consistent (vs. sporadic) attendance, participants will receive a bonus for every two consecutive sessions attended. Second, to support completion of the full PET protocol, participants will receive an additional bonus upon completion of Session 12.

Also known as: Contingency management

OAT+PET+

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vermont: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

University of Vemont

Burlington, Vermont, 05401, United States

Location

Related Publications (1)

• Peck KR, Giannini J, Badger GJ, Cole R, Sigmon SC. A novel prolonged exposure therapy protocol for improving therapy session attendance and PTSD symptoms among adults receiving buprenorphine or methadone treatment. Drug Alcohol Depend. 2025 Jan 1;266:112507. doi: 10.1016/j.drugalcdep.2024.112507. Epub 2024 Nov 27.

  PMID: 39642783 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Opioid-Related Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Narcotic-Related Disorders; Chemically-Induced Disorders

Results Point of Contact

• Title: Dr. Kelly R. Peck, Ph.D.
• Organization: University of Vermont

Kelly.Peck@uvm.edu

8026569610

Study Officials

• Kelly Peck, Ph.D.

  University of Vermont

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The present study is a three condition, parallel group, randomized trial to investigate the contribution of prolonged exposure therapy (PET) above and beyond opioid agonist treatment (OAT) alone for reducing PTSD symptoms among adults with concurrent PTSD and opioid use disorder. 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 12 weekly PET sessions with a trained therapist. Finally, OAT+PET+ participants will receive the procedures for the OAT+PET group plus monetary incentives contingent upon completion of PET sessions.

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 26, 2019
• Study Start: April 6, 2021
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: January 9, 2025
• Results First Posted: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)