Integrated Treatment for Opioid Use Disorder and PTSD

ConditionsOpioid Use Disorder Posttraumatic Stress Disorder (PTSD)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-70

SponsorMedical University of South Carolina

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

76 Participants

are divided into 2 treatment groups

Group A: HOPE TherapyExperimental treatment 1 intervention

Group B: Treatment as UsualNo intervention 0 interventions

Trial outcomes

Primary outcomes

Change in Opioid Use

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

Time frame

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.

Time frame

through study treatment completion, an average of 12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of South Carolina

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

National Institutes of Health (NIH)

Collaborator

Source ClinicalTrials.gov

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