Therapy for Opioid Use Disorder and PTSD
Integrated Treatment for Co-Occurring Opioid Use Disorder and Posttraumatic Stress Disorder
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT06641115 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with unmanaged psychiatric conditions or those at immediate risk of suicide may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Charleston, South Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.