NCT06641115

Integrated Treatment for Opioid Use Disorder and PTSD

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Opioid Use Disorder
• Posttraumatic Stress Disorder (PTSD)

Interventions

Type	Name	Description
BEHAVIORAL	HOPE Therapy	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

Timeline

• Start date: 2025-03-01
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2024-10-15
• Last updated: 2025-11-28

Locations

1 site across 1 country: United States