Project COMET: Massed Prolonged Exposure for PTSD and SUD

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

Conditions

• Posttraumatic Stress Disorder (PTSD)
• Substance Use Disorders (SUD)
• Comorbidity
• Trauma and Stressor Related Disorders

Interventions

BEHAVIORAL

Massed Prolonged Exposure Therapy (M-PE)

Massed Prolonged Exposure (M-PE) is a trauma-focused, evidence-based behavioral intervention for posttraumatic stress disorder (PTSD). It is delivered over a compressed timeline (e.g., 10 sessions over 2-4 weeks) as opposed to weekly sessions over 3-4 months. This format has been shown to accelerate PTSD symptom reduction and reduce treatment dropout. In this study, M-PE will be delivered concurrently with an Intensive Outpatient Program (IOP) for substance use disorder (SUD) at Gateway Community Services. Sessions will be led by trained clinicians using a standardized PE protocol, with treatment including imaginal exposure, in vivo exposure, and processing.

BEHAVIORAL

Standard outpatient SUD care

Patients randomized to usual care will receive standard intensive outpatient SUD treatment. * Resilience group (weekly) * Peer support * Individual therapy from a variety of modalities

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• University of California, San Diego

  collaborator OTHER

• University of Minnesota

  collaborator OTHER

• Rutgers, The State University of New Jersey

  lead OTHER

Principal Investigators

• Sonya Norman Professor Of Clinical, Psychiatry, Ph.D · University of California, San Diego

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-02

Primary Completion

2029-06-30

Completion

2029-06-30

Countries

• United States

Study Locations