Clinical trial Recruiting at 1 site Interventional Ages 18 to 70

Therapy for Opioid Use Disorder and PTSD

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

Run by Medical University of South Carolina · NCT06641115 · Data updated 2026-11-12

This study is testing a new therapy called HOPE to see if it helps people with both opioid use disorder and PTSD feel better when combined with their current medication.

Quick facts

Study typeInterventional
Ages18 Years to 70 Years
SexAll
Enrollment76 (estimated)
SponsorMedical University of South Carolina
Academic / other
Locations1 site (Charleston, South Carolina)
StatusRecruiting
StartedMarch 1, 2025
Main results expectedAugust 2027
Study endsAugust 2027
Registry record updatedNovember 28, 2025
Trial IDNCT06641115 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18-70 who meet the diagnostic criteria for both opioid use disorder and PTSD and are stable on medication for OUD.

Probably not a fit

Patients with unmanaged psychiatric conditions or those at immediate risk of suicide may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study tests a therapy intervention called HOPE for individuals suffering from both opioid use disorder (OUD) and posttraumatic stress disorder (PTSD). Participants will be required to be on stable medication for OUD and will undergo a 10-12 week therapy program while completing surveys. The study aims to evaluate the effectiveness of combining HOPE therapy with medication for OUD compared to medication alone. By using ecological momentary assessments, the study will also explore the relationship between daily PTSD symptoms and opioid cravings.

Why it matters

Potential benefit: If successful, this intervention could significantly improve treatment outcomes for patients with co-occurring opioid use disorder and PTSD.

How similar studies have gone: While there is a lack of established evidence-based interventions for this dual diagnosis, the approach of integrating behavioral therapy with medication is promising and has shown potential in related studies.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Medical University of South Carolina
    Charleston, South Carolina, United States
    Recruiting

Study contacts

  • Principal investigator: Tanya Saraiya, PhD — Medical University of South Carolina
  • Study coordinator: Tanya C Saraiya, Ph.D.
  • Email: saraiya@musce.edu
  • Phone: 8438762374

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.