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Prolonged Exposure Therapy for PTSD and Opioid Use Disorder

Primary Purpose

Post Traumatic Stress Disorder, Opioid-use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prolonged Exposure Therapy
Attendance-based monetary incentives
Sponsored by
University of Vermont
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder focused on measuring Post Traumatic Stress Disorder, Opioid-use Disorder, Prolonged Exposure Therapy, Opioid Agonist Therapy, Financial Incentives, Substance Use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of VemontRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

OAT as usual

OAT+PET

OAT+PET+

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

Posttraumatic stress disorder (PTSD) symptom severity
Mean 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 higher scores indicating more severe symptoms of PTSD.

Secondary Outcome Measures

Posttraumatic stress disorder (PTSD) symptom severity
Mean PTSD symptom severity will be measured by the PTSD Checklist for DSM-V (PCL-5) total score. The PCL-5 is a self-report measure that produces a total score that is obtained by summing the scores for each of the the 20 items. Scores range from 0-80 with higher scores indicating more severe symptoms of PTSD.
Anxiety symptom severity
Mean anxiety symptom severity will be measured by the Beck Anxiety Inventory (BAI) total score. The BAI is a self-report measure that produces a total score that is obtained by summing the scores for each of the 21 items. Scores range from 0-63 with higher scores indicating more severe symptoms of anxiety.
Depression symptom severity
Mean depression symptom severity will be measured by the Beck Depression Inventory (BDI-II) total score. The BDI-II is a self-report measure that produces a total score that is obtained by summing the scores for each of the 21 items. Scores range from 0-63 with higher scores indicating more severe symptoms of depression.
Illicit opioid abstinence
Illicit opioid abstinence will be measured by the overall percentage of urinalyses biochemically verified to be abstinent for illicit opioids during the treatment period
Problems related to substance use
Problems related to substance use will be measured by the Addiction Severity Index (ASI) subscale scores. The ASI is a clinician-administered structured interview that produces seven subscale scores (employment, psychiatric, family/social, alcohol, medical, legal, and drug severity). Scores for each subscale range from 0-1 with higher scores indicating more severe psychosocial consequences of substance use.
Frequency of substance use
Frequency of substance use will be measured by the Timeline Follow-back (TLFB). The TLFB will be administered by an interviewer and involves participants retrospectively estimating their illicit opioid and other substance use (e.g., marijuana and cocaine) during the 30 days prior to the interview date. Frequency of substance use will be measured as the number of days that the participants report using illicit substances during the 30 days prior to the interview date.
Pain intensity and interference
Pain intensity and interference will be measured by Brief Pain Inventory -Short Form (BPI-SF). The BPI-SF is a self-report measure of pain intensity and interference in function during the past week. The pain intensity section of the BPI includes four intensity ratings; whereas, the functional interference section consists of seven items. Items assessing pain intensity and functional interference are scored from 0-10 with higher scores indicating greater pain severity and functional interference, respectively.
Delay discounting
Rates of delay discounting will be measured by the Monetary Choice Questionnaire (MCQ). The MCQ is a self-report measure consisting of items that presents a choice between smaller, immediate and larger, delayed monetary rewards. The magnitude of delayed monetary rewards varies from $25-$85. "Discounting rates," or k-values, are calculated from individuals' choices across items and represent rates at which the individual devalues rewards overall.
Insomnia severity
Insomnia severity will be measured by the Insomnia Severity Index (ISI). The ISI is a self-report measure that consists of 7 items that are scored from 0-4. The ISI produces a total score that is obtained by summing the scores for each of the the 7 items. Scores range from 0-28 with higher scores indicating more severe symptoms of insomnia.

Full Information

First Posted
September 17, 2019
Last Updated
October 4, 2022
Sponsor
University of Vermont
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1. Study Identification

Unique Protocol Identification Number
NCT04104022
Brief Title
Prolonged Exposure Therapy for PTSD and Opioid Use Disorder
Official Title
Treating Posttraumatic Stress Disorder in Patients With Opioid Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 6, 2021 (Actual)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
January 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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 more severe mental health symptoms and worse opioid agonist treatment (OAT) outcomes relative to either diagnosis alone. Prolonged exposure therapy (PET) is an efficacious manualized 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 observed improvements were a function of PET versus the psychopharmacological effects of OAT itself. Therefore, the question of whether OAT alone may attenuate PTSD symptomatology in the absence of intensive cognitive-behavioral therapy remains unanswered and is important given the prevalence and deleterious effects of PTSD among OAT patients, as well as the ever-present constraints on mental health resources in substance use treatment settings. The present study will investigate the contribution of PET above and beyond OAT alone for reducing PTSD symptomatology among adults with concurrent PTSD and OUD. Eligible participants who complete the informed consent process 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. Follow-up assessment visits will be conducted in-person at our clinic following all relevant COVID-19-related CDC guidelines and university safety protocols. However, study measures may also be administered remotely via phone or telemedicine to reduce the risk of COVID-19 transmission. 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. Therapy sessions will be conducted at our research clinic or remotely via telemedicine to reduce the risk of COVID-19 transmission. 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 disorder (SUDs), the use of incentives will ensure that we evaluate PET effects among patients who receive a sufficient dose of therapy. For inclusion in the study, participants must meet the following criteria: (a) > 18 years of age, (b) currently maintained on a stable methadone or buprenorphine dose for the treatment of OUD for >1 month prior to the study, (c) endorse >1 lifetime traumatic event, and (c) meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) PTSD diagnostic criteria (American Psychiatric Association, 2013). Exclusion criteria include: (a) the presence of an acute psychotic disorder, bipolar disorder with an active manic episode (but not simply the presence of bipolar disorder), (b) imminent risk for suicide, (c) a medical condition that may interfere with consent or participation (e.g., organic brain syndrome, dementia, head injury, neuropathy, etc.), and (d) illiteracy in English. Participants randomized to OAT as usual will continue to receive standard buprenorphine or methadone maintenance from their current treatment provider and complete assessments of PTSD symptom severity, psychosocial functioning and drug use at Study Weeks 4, 8, and 12. Follow-up assessment visits will be conducted in-person at our clinic following all relevant COVID-19-related CDC guidelines and university safety protocols. However, study measures may also be administered remotely via phone or telemedicine to reduce the risk of COVID-19 transmission. In addition to receiving standard buprenorphine- or methadone-maintenance treatment as described above and completing monthly assessments, OAT+PET participants will also receive 12 individual sessions of PET. Therapy sessions will be conducted at our research clinic or remotely via telemedicine to reduce the risk of COVID-19 transmission. Beginning in Study Week 1, OAT+PET participants will complete weekly 60-minute PET sessions provided by a therapist trained in PET. Participants randomized to the OAT+PET+ condition will receive the procedures noted above for the OAT+PET group plus monetary incentives delivered contingent upon completion of PET sessions. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
135 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OAT as usual
Arm Type
No Intervention
Arm Description
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.
Arm Title
OAT+PET
Arm Type
Active Comparator
Arm Description
In addition to receiving OAT and completing monthly assessments, OAT+PET participants will receive 12 weekly PET sessions with a trained therapist.
Arm Title
OAT+PET+
Arm Type
Experimental
Arm Description
OAT+PET+ participants will receive the procedures for the OAT+PET group plus monetary incentives contingent upon completion of PET sessions
Intervention Type
Behavioral
Intervention Name(s)
Prolonged Exposure Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Attendance-based monetary incentives
Other Intervention Name(s)
Contingency management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Posttraumatic stress disorder (PTSD) symptom severity
Description
Mean 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 higher scores indicating more severe symptoms of PTSD.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Posttraumatic stress disorder (PTSD) symptom severity
Description
Mean PTSD symptom severity will be measured by the PTSD Checklist for DSM-V (PCL-5) total score. The PCL-5 is a self-report measure that produces a total score that is obtained by summing the scores for each of the the 20 items. Scores range from 0-80 with higher scores indicating more severe symptoms of PTSD.
Time Frame
12 weeks
Title
Anxiety symptom severity
Description
Mean anxiety symptom severity will be measured by the Beck Anxiety Inventory (BAI) total score. The BAI is a self-report measure that produces a total score that is obtained by summing the scores for each of the 21 items. Scores range from 0-63 with higher scores indicating more severe symptoms of anxiety.
Time Frame
12 weeks
Title
Depression symptom severity
Description
Mean depression symptom severity will be measured by the Beck Depression Inventory (BDI-II) total score. The BDI-II is a self-report measure that produces a total score that is obtained by summing the scores for each of the 21 items. Scores range from 0-63 with higher scores indicating more severe symptoms of depression.
Time Frame
12 weeks
Title
Illicit opioid abstinence
Description
Illicit opioid abstinence will be measured by the overall percentage of urinalyses biochemically verified to be abstinent for illicit opioids during the treatment period
Time Frame
12 weeks
Title
Problems related to substance use
Description
Problems related to substance use will be measured by the Addiction Severity Index (ASI) subscale scores. The ASI is a clinician-administered structured interview that produces seven subscale scores (employment, psychiatric, family/social, alcohol, medical, legal, and drug severity). Scores for each subscale range from 0-1 with higher scores indicating more severe psychosocial consequences of substance use.
Time Frame
12 weeks
Title
Frequency of substance use
Description
Frequency of substance use will be measured by the Timeline Follow-back (TLFB). The TLFB will be administered by an interviewer and involves participants retrospectively estimating their illicit opioid and other substance use (e.g., marijuana and cocaine) during the 30 days prior to the interview date. Frequency of substance use will be measured as the number of days that the participants report using illicit substances during the 30 days prior to the interview date.
Time Frame
12 weeks
Title
Pain intensity and interference
Description
Pain intensity and interference will be measured by Brief Pain Inventory -Short Form (BPI-SF). The BPI-SF is a self-report measure of pain intensity and interference in function during the past week. The pain intensity section of the BPI includes four intensity ratings; whereas, the functional interference section consists of seven items. Items assessing pain intensity and functional interference are scored from 0-10 with higher scores indicating greater pain severity and functional interference, respectively.
Time Frame
12 weeks
Title
Delay discounting
Description
Rates of delay discounting will be measured by the Monetary Choice Questionnaire (MCQ). The MCQ is a self-report measure consisting of items that presents a choice between smaller, immediate and larger, delayed monetary rewards. The magnitude of delayed monetary rewards varies from $25-$85. "Discounting rates," or k-values, are calculated from individuals' choices across items and represent rates at which the individual devalues rewards overall.
Time Frame
12 weeks
Title
Insomnia severity
Description
Insomnia severity will be measured by the Insomnia Severity Index (ISI). The ISI is a self-report measure that consists of 7 items that are scored from 0-4. The ISI produces a total score that is obtained by summing the scores for each of the the 7 items. Scores range from 0-28 with higher scores indicating more severe symptoms of insomnia.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly Peck, Ph.D.
Phone
8026569610
Email
kelly.peck@uvm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole Twohig, B.A.
Phone
8026560079
Email
Nicole.Twohig@uvm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly Peck, Ph.D.
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Vemont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly R Peck, Ph.D.
Phone
802-656-9610
Email
Kelly.Peck@uvm.edu

12. IPD Sharing Statement

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Prolonged Exposure Therapy for PTSD and Opioid Use Disorder

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