NCT06641115 Integrated Treatment for Opioid Use Disorder and PTSD
| NCT ID | NCT06641115 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of South Carolina |
| Condition | Opioid Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 76 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 76 participants in total. It began in 2025-03-01 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Tanya Saraiya, PhD
PRINCIPAL INVESTIGATOR
Medical University of South Carolina
Frequently Asked Questions
Who can join the NCT06641115 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Opioid Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06641115 currently recruiting?
Yes, NCT06641115 is actively recruiting participants. Contact the research team at saraiya@musce.edu for enrollment information.
Where is the NCT06641115 trial being conducted?
This trial is being conducted at Charleston, United States.
Who is sponsoring the NCT06641115 clinical trial?
NCT06641115 is sponsored by Medical University of South Carolina. The principal investigator is Tanya Saraiya, PhD at Medical University of South Carolina. The trial plans to enroll 76 participants.