Actively Recruiting
Integrated Treatment for Co-Occurring Opioid Use Disorder and Posttraumatic Stress Disorder
Led by Medical University of South Carolina · Updated on 2025-11-28
76
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Medical University of South Carolina
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate a therapy called HOPE for individuals who have both opioid use disorder (OUD) and posttraumatic stress disorder (PTSD). Up to half of people with OUD also experience PTSD, yet no established behavioral treatments currently address both conditions together. The study will test whether combining HOPE therapy with medications for opioid use disorder improves outcomes compared to medications alone. Researchers will also use daily assessments to track opioid use, cravings, and PTSD symptoms to better understand their relationship. Participants will be randomly assigned to either receive the HOPE therapy along with their usual medications for OUD or continue with medications and standard community substance use treatments without HOPE. The HOPE therapy involves 10 to 12 weekly sessions focusing on trauma and substance use. All participants will continue taking their prescribed medications for opioid use disorder throughout the study. During the study, participants will complete surveys and ecological momentary assessments that capture daily opioid use, cravings, and PTSD symptoms. The main outcomes measured are changes in opioid use and PTSD severity over the 12-week treatment period. The involvement includes attending therapy sessions if assigned, taking medications as prescribed, and completing regular assessments. The total participation duration is about 12 weeks, focusing on evaluating the combined treatment's feasibility and effects.
CONDITIONS
Brief Title
Integrated Treatment for Opioid Use Disorder and PTSD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Any gender; any race or ethnicity; aged 18-70 years old
- English-speaking
- Meet DSM-5 diagnostic criteria for opioid use disorder
- Meet DSM-5 diagnostic criteria for posttraumatic stress disorder and recall their traumatic event
- Maintained on a stable dose of medication for opioid use disorder for at least 1 month
- Stable dose of psychotropic medications for at least 1 month before study start if applicable
You will not qualify if you...
- Unmanaged psychiatric conditions such as psychosis, mania, or bipolar disorder
- Immediate suicide risk or high-risk behaviors as determined by study team
- Concurrent non-opioid substance use disorder if it is the primary substance of use
- Currently enrolled in other evidence-based psychotherapy for substance use disorders or PTSD outside standard treatments
- Medical problems needing urgent intensive treatment, such as unstable end stage liver disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 to 12 weeks
Participants receive an integrated 10-12 week behavioral treatment called HOPE therapy combined with medications for opioid use disorder, or medications alone as standard community treatment.
Weekly visits during treatment
Duration - Up to 12 weeks after treatment completion
Participants continue to be monitored for opioid use and PTSD symptoms after completing the treatment phase.
1 to 2 visits depending on symptom monitoring
Trial Site Locations
Total: 1 location
1
Medical University of South Carolina
Charleston, South Carolina, United States, 29403
Actively Recruiting
Research Team
T
Tanya C Saraiya, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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