NCT06968832 Project COMET: Massed Prolonged Exposure for PTSD and SUD
| NCT ID | NCT06968832 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rutgers, The State University of New Jersey |
| Condition | Posttraumatic Stress Disorder (PTSD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 168 participants |
| Start Date | 2025-09-02 |
| Primary Completion | 2029-06-30 |
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 168 participants in total. It began in 2025-09-02 with a primary completion date of 2029-06-30.
⚠ 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
The goal of this clinical trial is to learn if Massed Prolonged Exposure Therapy (M-PE) can improve PTSD symptoms and reduce substance use in adults receiving intensive outpatient (IOP) treatment for substance use disorder (SUD). The main questions it aims to answer are: * Does M-PE reduce PTSD symptoms more effectively than trauma treatment as usual (TAU)? * Does M-PE reduce the number of days participants use substances? * How do patient-centered outcomes (such as depression, suicidal thoughts, and quality of life) differ between M-PE and trauma TAU? * Researchers will compare M-PE to treatment as usual to see if M-PE leads to better mental health and substance use outcomes and lower dropout rates. Participants will: * Attend multiple therapy sessions per week (M-PE) or receive usual care * Complete assessments at baseline, during treatment, end-of-treatment, 1-month, 3-month, and 6-month follow-up * Share feedback through surveys and interviews about their experience in the program
Eligibility Criteria
Inclusion Criteria: * Age 18+ * Enrolled in SUD treatment at Gateway Community Services * Meet DSM-5 criteria for a SUD (Tobacco Use Disorder alone not sufficient for inclusion) * Meet DSM-5 criteria for PTSD * Able to give informed consent Exclusion Criteria: * severe cognitive impairment * current suicidal or homicidal intent requiring immediate treatment * current unstable psychotic or manic symptoms not attributable to SUD
Contact & Investigator
Denise Hien Helen E. Chaney Endowed Chair in Alcohol Studies, Ph.D
✉ denise.hien@smithers.rutgers.edu📞 848-445-0749
Sonya Norman Professor Of Clinical, Psychiatry, Ph.D
PRINCIPAL INVESTIGATOR
University of California, San Diego
Frequently Asked Questions
Who can join the NCT06968832 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Posttraumatic Stress Disorder (PTSD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06968832 currently recruiting?
Yes, NCT06968832 is actively recruiting participants. Contact the research team at denise.hien@smithers.rutgers.edu for enrollment information.
Where is the NCT06968832 trial being conducted?
This trial is being conducted at Jacksonville, United States.
Who is sponsoring the NCT06968832 clinical trial?
NCT06968832 is sponsored by Rutgers, The State University of New Jersey. The principal investigator is Sonya Norman Professor Of Clinical, Psychiatry, Ph.D at University of California, San Diego. The trial plans to enroll 168 participants.
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