Integrated Treatment for Opioid Use Disorder and PTSD

NCT06641115 | Recruiting DMC

• 2 other identifiers: Pro00138487K23DA055209
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test a therapy intervention, HOPE, for individuals with opioid use disorder and posttraumatic stress disorder. Interested individuals will need to be taking medications for opioid use disorder (e.g., suboxone, naltrexone, methadone). Interested participants will complete a 10-12 week therapy, and be asked to complete surveys.

Conditions

Opioid Use Disorder; Posttraumatic Stress Disorder (PTSD)

Keywords

Mental Health; Psychiatry; Substance Use; PTSD; Opioid Use; Therapy

Outcome Measures

Primary Outcomes (2)

• Change in Opioid Use

  Opioid use (percent days using) as measured by urine drug screens

  through study treatment completion, an average of 12 weeks

• Change in Posttraumatic Stress Disorder Symptoms

  Posttraumatic Stress Disorder symptoms as measured by the Clinician Administered Posttraumatic Stress Disorder Scale for the Diagnostic and Statistical Manual for Mental Disorders, 5th Edition or the CAPS-5. Total severity scores on this measure range from 0-80 with higher scores denoting more severe posttraumatic stress disorder symptoms.

  through study treatment completion, an average of 12 weeks

Study Arms (2)

HOPE Therapy

EXPERIMENTAL

Helping Opioid Use and PTSD with Exposure (HOPE) therapy is an integrated 10-12 week treatment for opioid use disorder and trauma/posttraumatic stress disorder

Behavioral: HOPE Therapy

Treatment as Usual

NO INTERVENTION

Participants take medications as prescribed and attend standard community substance use treatment services

Interventions

HOPE Therapy BEHAVIORAL

Helping Opioid Use and PTSD with Exposure (HOPE) therapy is an integrated 10-12 week treatment for opioid use disorder and trauma/posttraumatic stress disorder

HOPE Therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any gender; any race or ethnicity; aged 18-70 years old.
• English-speaking
• Meet DSM-5 diagnostic criteria for OUD.
• Meet DSM-5 diagnostic criteria for PTSD and have some memory of their index traumatic event.
• Must be maintained on a stable dose of medication for OUD for at least 1 month.
• Participants taking psychotropic medications will be required to be maintained on a stable dose for at least 1 month before study initiation.

You may not qualify if:

• Participants presenting with psychiatric contraindications (e.g., unmanaged psychosis or mania, or bipolar) will be excluded and referred clinically.
• Participants considered an immediate suicide risk, with current suicidal ideation and a plan of intent, or displaying other high-risk behaviors (i.e., MOUD refusal, risky fentanyl use, etc.), as determined by the PI and study team. These individuals will complete a safety plan and be referred for treatment.
• Participants meeting DSM-5 criteria for a concurrent, non-opioid, substance use disorder and who report that the other substance is their primary substance of use. These participants will be referred clinically for treatment.
• Participants enrolled in ongoing evidence-based psychotherapy for substance use disorders or PTSD outside of medications for OUD and standard psychotherapy groups in treatment programs.
• Medical problems requiring immediate and intensive treatment, such as unstable or symptomatic end stage liver disease.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute on Drug Abuse (NIDA): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders; Stress Disorders, Post-Traumatic; Psychological Well-Being; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Personal Satisfaction; Behavior

Study Officials

• Tanya Saraiya, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tanya C Saraiya, Ph.D.

CONTACT

8438762374; saraiya@musce.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 15, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)