RECRUITING

Integrated Treatment for Opioid Use Disorder and PTSD

Conditions

Opioid Use Disorder Posttraumatic Stress Disorder (PTSD)Mental Health Psychiatry Substance Use PTSD Opioid Use Therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Integrated Treatment for Co-Occurring Opioid Use Disorder and Posttraumatic Stress Disorder

Quick Facts

Study Start:2025-03-01

Study Completion:2027-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06641115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Tanya C Saraiya, Ph.D.

CONTACT

8438762374

saraiya@musce.edu

Principal Investigator

Tanya Saraiya, PhD

PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Study Locations (Sites)

Medical University of South Carolina

Charleston, South Carolina, 29403

United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

Tanya Saraiya, PhD, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-01

Study Completion Date2027-08

Study Record Updates

Study Start Date2025-03-01

Study Completion Date2027-08

Terms related to this study

Keywords Provided by Researchers

Mental Health
Psychiatry
Substance Use
PTSD
Opioid Use
Therapy

Additional Relevant MeSH Terms

Opioid Use Disorder
Posttraumatic Stress Disorder (PTSD)