Clinical trial NCT06641115: Integrated Treatment for Opioid Use Disorder and PTSD
Official title: Integrated Treatment for Co-Occurring Opioid Use Disorder and Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Posttraumatic Stress Disorder (PTSD)
Keywords: Mental Health
Psychiatry
Substance Use
PTSD
Opioid Use
Therapy
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institutes of Health (NIH)
First posted: 2024-10-15
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Up to half of individuals with OUD have PTSD, but to date, there are no established evidence-based behavioral interventions that concurrently address OUD and PTSD symptoms. The proposed study directly addresses this major clinical gap by testing whether augmenting medications for OUD by testing an adapted, trauma-focused, integrated behavioral treatment for substance use disorders and co-occurring PTSD (i.e., Helping Opioid Use and PTSD with Exposure; HOPE) will enhance clinical outcomes. The investigators will test HOPE combined with medications for OUD (MOUD) versus MOUD-only in a randomized clinical trial among 76 individuals with OUD and PTSD to evaluate feasibility and preliminary efficacy in reducing opioid use and PTSD severity. Both conditions will also complete ecological momentary assessments (EMA) to assess for daily opioid use, craving, and PTSD symptoms. EMA will allow for the assessment of the associations between daily PTSD symptoms and opioid craving and use, which may then inform treatment development.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Opioid Use
timeFrame: through study treatment completion, an average of 12 weeks
measure: Change in Posttraumatic Stress Disorder Symptoms
timeFrame: through study treatment completion, an average of 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Tanya Saraiya, PhD
role: PRINCIPAL_INVESTIGATOR
References: