Recruiting

M-PE

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT06968832

Conditions

Posttraumatic Stress Disorder (PTSD)

Substance Use Disorders (SUD)

Comorbidity

Trauma and Stressor Related Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Massed Prolonged Exposure Therapy (M-PE)

Standard outpatient SUD care

Study Details

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

Conditions

Posttraumatic Stress Disorder (PTSD)

Substance Use Disorders (SUD)

Comorbidity

Trauma and Stressor Related Disorders

Study ID

NCT06968832

Start date

Sep 2, 2025

Status verified date

Oct, 2025

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Jun 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

168 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Massed Prolonged Exposure (M-PE) + Intensive Outpatient Program (IOP)

Participants randomized to this arm will receive Massed Prolonged Exposure (M-PE) therapy, a gold-standard treatment for PTSD delivered multiple times per week over 2-4 weeks. M-PE will be integrated into the standard Intensive Outpatient Program (IOP) for substance use disorder (SUD) at Gateway Community Services, Inc. This arm is designed to evaluate the effectiveness of delivering M-PE concurrently with SUD treatment in improving PTSD symptoms, reducing substance use, and improving patient-centered outcomes.

active comparator: Trauma Treatment as Usual (TAU) - IOP with Trauma Skills Group

Participants randomized to this arm will receive the standard Intensive Outpatient Program (IOP) for substance use disorder (SUD), which includes a weekly trauma skills group as part of usual care. This comparator arm allows for evaluation of whether M-PE enhances outcomes beyond those achieved through trauma-informed IOP care.

Interventions

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.

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

Primary outcome measure

  • Clinician Administered PTSD Scale for DSM-5 (CAPS-5) [ Time Frame: Baseline; End of Treatment (6 weeks post-randomization); 1-month (10 weeks), 3-month (18 weeks), and 6-month (30 weeks) post-randomization follow-up ]
  • Time Line Follow back (TLFB) [ Time Frame: Baseline; End of Treatment (6 weeks post-randomization); 1-month (10 weeks), 3-month (18 weeks), and 6-month (30 weeks) post-randomization follow-up ]

Central Contacts and Locations

Central contacts

Denise Hien Helen E. Chaney Endowed Chair in Alcohol Studies, Ph.D

848-445-0749denise.hien@smithers.rutgers.edu

Locations

Gateway Community Services

Recruiting

Jacksonville, Florida, United States, 32204

Contacts

Candy Hodgkins CEO - Gateway Comunity Services, Inc., Doctor of Philosophy (Ph.D.)

1-877-389-9966chodgkins@gwjax.com

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Oct 27, 2025

Last verified

Oct, 2025

Keywords

  • Posttraumatic Stress Disorder (PTSD)
  • Substance Use Disorder (SUD)
  • PTSD/SUD Comorbidity
  • Prolonged Exposure Therapy (PE)
  • Massed Prolonged Exposure (M-PE)
  • Randomized Clinical Trial (RCT)
  • Treatment as Usual (TAU)
  • Integrated PTSD and SUD Treatment
  • Implementation Science
  • Trauma-Focused Treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2025-10-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.