Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06641115

Integrated Treatment for Opioid Use Disorder and PTSD

This study will test a therapy intervention, HOPE, for individuals with opioid use disorder and posttraumatic stress disorder. Interested individuals will need to be taking medications for opioid use disorder (e.g., suboxone, naltrexone, methadone). Interested participants will complete a 10-12 week therapy, and be asked to complete surveys.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

Location status: Recruiting

Location contact

Tanya C Saraiya, PhD

CONTACT

[email protected]

8438762374

About this study

Up to half of individuals with OUD have PTSD, but to date, there are no established evidence-based behavioral interventions that concurrently address OUD and PTSD symptoms. The proposed study directly addresses this major clinical gap by testing whether augmenting medications for OUD by testing an adapted, trauma-focused, integrated behavioral treatment for substance use disorders and co-occurring PTSD (i.e., Helping Opioid Use and PTSD with Exposure; HOPE) will enhance clinical outcomes. The investigators will test HOPE combined with medications for OUD (MOUD) versus MOUD-only in a randomized clinical trial among 76 individuals with OUD and PTSD to evaluate feasibility and preliminary efficacy in reducing opioid use and PTSD severity. Both conditions will also complete ecological momentary assessments (EMA) to assess for daily opioid use, craving, and PTSD symptoms. EMA will allow for the assessment of the associations between daily PTSD symptoms and opioid craving and use, which may then inform treatment development.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

HOPE Therapy

Behavioral

Helping Opioid Use and PTSD with Exposure (HOPE) therapy is an integrated 10-12 week treatment for opioid use disorder and trauma/posttraumatic stress disorder

Primary outcomes

  1. Change in Opioid Use

    Time frame: through study treatment completion, an average of 12 weeks

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

  2. Change in Posttraumatic Stress Disorder Symptoms

    Time frame: through 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tanya C Saraiya, Ph.D.

CONTACT

[email protected]

8438762374

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • National Institutes of Health (NIH)

Registry information

Official study title

Integrated Treatment for Co-Occurring Opioid Use Disorder and Posttraumatic Stress Disorder

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 15, 2024
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.