Massed Prolonged Exposure for PTSD and Substance Use
Project COMET: Hybrid Effectiveness-Implementation Trial of Massed PTSD Treatment in a Community Substance Use Program
NA · Rutgers, The State University of New Jersey · NCT06968832
This study tests whether giving Prolonged Exposure therapy in a massed format during intensive outpatient treatment helps adults with PTSD and substance use disorders reduce PTSD symptoms and days of substance use.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 168 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rutgers, The State University of New Jersey (other) |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT06968832 on ClinicalTrials.gov |
What this trial studies
This randomized two-group hybrid effectiveness-implementation trial compares Massed Prolonged Exposure (M-PE) delivered during an intensive outpatient program (IOP) for substance use disorder to trauma treatment as usual (TAU). Participants receive multiple therapy sessions per week (M-PE) or usual trauma care while completing assessments at baseline, during treatment, end-of-treatment, and at 1-, 3-, and 6-month follow-ups. The trial measures PTSD symptoms, days of substance use, depression, suicidal ideation, quality of life, and dropout rates, and collects participant feedback via surveys and interviews. The mixed-methods design aims to determine whether M-PE improves clinical outcomes and retention when integrated into SUD IOP care.
Who should consider this trial
Good fit: Adults 18 or older enrolled in SUD intensive outpatient treatment who meet DSM-5 criteria for both PTSD and a substance use disorder and can give informed consent are the ideal candidates.
Not a fit: Patients with severe cognitive impairment, current suicidal or homicidal intent requiring immediate care, or unstable psychotic or manic symptoms (not attributable to SUD) are unlikely to be eligible or benefit from this approach.
Why it matters
Potential benefit: If successful, M-PE could speed PTSD symptom improvement, reduce substance use days, and lower dropout rates when delivered during intensive SUD treatment.
How similar studies have performed: Prior outpatient work suggests massed Prolonged Exposure can improve PTSD symptoms and reduce dropout, but delivering M-PE concurrently within SUD IOPs is still preliminary and requires further testing.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Jacksonville, Florida
- Gateway Community Services — Jacksonville, Florida, United States (RECRUITING)
Study contacts
- Principal investigator: Sonya Norman Professor Of Clinical, Psychiatry, Ph.D — University of California, San Diego
- Study coordinator: Denise Hien Helen E. Chaney Endowed Chair in Alcohol Studies, Ph.D
- Email: denise.hien@smithers.rutgers.edu
- Phone: 848-445-0749
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.
Conditions: Posttraumatic Stress Disorder, Substance Use Disorders, Comorbidity, Trauma and Stressor Related Disorders, Substance Use Disorder, PTSD/SUD Comorbidity, Prolonged Exposure Therapy, Massed Prolonged Exposure