Clinical Trial

Project COMET: Massed Prolonged Exposure for PTSD and SUD

Study acronym: PROJECT COMET
Recruiting
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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
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-05-05.
Status change: Not Yet Recruiting → Recruiting 2025-10-23
Trial Details
NCT Number NCT06968832
Lead Sponsor Rutgers, The State University of New Jersey
Collaborators: National Institute of Mental Health (NIMH), University of California, San Diego, University of Minnesota
Conditions Posttraumatic Stress Disorder (PTSD), Substance Use Disorders (SUD), Comorbidity, Trauma and Stressor Related Disorders
Enrollment 168 participants
Start Date 2025-09-02
Primary Completion 2029-06-30 (estimated)
Study Completion 2029-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-10-27