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Integrated Treatment for Opioid Use Disorder and PTSD

This study is testing a new therapy called HOPE (Helping Opioid Use and PTSD with Exposure) for people who have both opioid use disorder (OUD) and posttraumatic stress disorder (PTSD). HOPE therapy is a 10-12 week program designed to address both conditions at the same time. You can join if you are 18-70 years old, speak English, and are already taking stable medication for your opioid use disorder (like suboxone, naltrexone, or methadone). The researchers want to see if HOPE therapy, combined with your current medication, can help reduce opioid use and PTSD symptoms. This study aims to enroll 76 participants, but its current recruitment status is unclear.

Study design
This is an interventional study that will enroll 76 participants. It will compare HOPE therapy plus medication for OUD against medication for OUD alone.
What's involved
You would complete a 10-12 week therapy program and fill out surveys. You will also complete daily assessments on your phone about opioid use, cravings, and PTSD symptoms.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes, such as changes in opioid use and PTSD symptoms, will be measured through study treatment completion, which is an average of 12 weeks.

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NCT06641115

Integrated Treatment for Opioid Use Disorder and PTSD

Recruiting
NAAges 18–70InterventionalTreatment
Medical University of South Carolina
~76 participants
Updated 2025-11-28 on ClinicalTrials.gov
What's tested:HOPE Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Opioid Use
Measured over through study treatment completion, an average of 12 weeks
+1 more outcome measured

Conditions

Opioid Use Disorder
Posttraumatic Stress Disorder (PTSD)

Explore related trials

Opioid Use DisorderPost-Traumatic Stress Disorder

Where it's being run

1 sites across 1 states
South Carolina1

Study leadership

  • Tanya Saraiya, PhD · PRINCIPAL_INVESTIGATOR · Medical University of South Carolina

Who to contact

Tanya C Saraiya, Ph.D.
[email protected]
8438762374
Email the study team

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Eligibility criteria

Inclusion

Any gender; any race or ethnicity; aged 18-70 years old.
English-speaking
Meet DSM-5 diagnostic criteria for OUD.
Meet DSM-5 diagnostic criteria for PTSD and have some memory of their index traumatic event.
Must be maintained on a stable dose of medication for OUD for at least 1 month.
Participants taking psychotropic medications will be required to be maintained on a stable dose for at least 1 month before study initiation.

Exclusion

Participants presenting with psychiatric contraindications (e.g., unmanaged psychosis or mania, or bipolar) will be excluded and referred clinically.
Participants considered an immediate suicide risk, with current suicidal ideation and a plan of intent, or displaying other high-risk behaviors (i.e., MOUD refusal, risky fentanyl use, etc.), as determined by the PI and study team. These individuals will complete a safety plan and be referred for treatment.
Participants meeting DSM-5 criteria for a concurrent, non-opioid, substance use disorder and who report that the other substance is their primary substance of use. These participants will be referred clinically for treatment.
Participants enrolled in ongoing evidence-based psychotherapy for substance use disorders or PTSD outside of medications for OUD and standard psychotherapy groups in treatment programs.
Medical problems requiring immediate and intensive treatment, such as unstable or symptomatic end stage liver disease.

What this trial measures

  • Change in Opioid Usethrough study treatment completion, an average of 12 weeks

    Opioid use (percent days using) as measured by urine drug screens

  • Change in Posttraumatic Stress Disorder Symptomsthrough study treatment completion, an average of 12 weeks

    Posttraumatic Stress Disorder symptoms as measured by the Clinician Administered Posttraumatic Stress Disorder Scale for the Diagnostic and Statistical Manual for Mental Disorders, 5th Edition or the CAPS-5. Total severity scores on this measure range from 0-80 with higher scores denoting more severe posttraumatic stress disorder symptoms.