Project COMET: Massed Prolonged Exposure for PTSD and SUD

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRutgers, The State University of New Jersey

About this trial

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

Qualifiers

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

Disqualifiers

severe cognitive impairment

current suicidal or homicidal intent requiring immediate treatment

current unstable psychotic or manic symptoms not attributable to SUD

Trial design

Treatments tested in this trial

  • Massed Prolonged Exposure Therapy (M-PE)
  • Standard outpatient SUD care

Treatment groups

168 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Rutgers, The State University of New Jersey

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

University of California, San Diego

Collaborator

University of Minnesota

Collaborator