Recruiting

Integrated Treatment

Sponsor:

Medical University of South Carolina

Code:

NCT06641115

Conditions

Opioid Use Disorder

Posttraumatic Stress Disorder (PTSD)

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

HOPE Therapy

Study Details

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)

Study ID

NCT06641115

Start date

Mar 1, 2025

Status verified date

Nov, 2025

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

76 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: HOPE Therapy

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

no intervention: Treatment as Usual

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

Interventions

HOPE Therapy

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

Primary outcome measure

  • Change in Opioid Use [ Time Frame: through study treatment completion, an average of 12 weeks ]
  • Change in Posttraumatic Stress Disorder Symptoms [ Time Frame: through study treatment completion, an average of 12 weeks ]

Central Contacts and Locations

Central contacts

Tanya C Saraiya, Ph.D.

8438762374saraiya@musce.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29403

Contacts

Tanya C Saraiya, PhD

8438762374saraiya@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

Nov 28, 2025

Last verified

Nov, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2025-11-28.