Developing and Testing Innovative Care Pathways for Screening and Treatment of OUD/PTSD in Jails
NCT07490717 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 338
Last updated 2026-03-24
Summary
Opioid overdose is the leading cause of death among people recently released from incarceration. Recent evidence also shows a rise in stimulant use among justice-involved populations, as well as growing rates of concurrent opioid and stimulant use. Yet, while there is growing research on opioid use disorder (OUD), stimulant use disorder (STUD), and substance use treatment in jails and prisons, studies find that few people who are referred to community substance use treatment actually initiate treatment after release. But, emerging research suggests that therapy for posttraumatic stress disorder (PTSD), a common and deleterious OUD and STUD comorbidity, could profoundly increase the likelihood of engagement with substance use treatment; however, this has not been tested in jails, and acceptable, appropriate, and feasible ways to identify and link people with probable PTSD and OUD/STUD in this setting to treatment are required to be able to examine this possibility. Therefore, this 4-year R33 aims to 1) describe engagement in and examine the implementation outcomes of an innovative approach to identifying and referring people with probable PTSD and OUD/STUD to needed treatment services and 2) the effectiveness and implementation outcomes of two competing models of subsequent trauma-focused therapy initiation timing (i.e., immediate initiation of therapy vs initiation upon community reentry) among people who demonstrate need for OUD/STUD services and who accept referral. To address Aim 1, the investigators will assess the implementation context for and subsequently implement a screening, brief intervention, and referral to treatment model that was adapted to identify and address the substance use and mental health needs of adults with probable PTSD and OUD/STUD in the jail setting (SBIRT-J) in the Pulaski County Regional Detention Facility; the investigators will describe engagement in and examine the implementation outcomes of the SBIRT-J model via a summative evaluation guided by the Consolidated Framework for Implementation Research. Specifically, there will be a survey and interview jail stakeholders (e.g., jail leadership, officers) to understand perceptions of the acceptability, appropriateness, and feasibility of the SBIRT-J model as well as SBIRT-J implementation determinants (i.e., barriers and facilitators), and use administrative data to understand the degree to which SBIRT-J is adopted during active enrollment in the R33 Aim 2 research trial and sustained in the 6 months after enrollment end. Fidelity to the SBIRT-J model will also be monitored and reported. To address Aim 2, the investigators will conduct a patient-randomized Hybrid type I implementation-effectiveness trial in which adults who are identified as having probable PTSD and OUD/STUD through the SBIRT-J model and who consent to participate in the trial are randomly assigned to either immediate initiation of therapy for PTSD in jail or initiation of PTSD therapy upon release. The primary effectiveness outcome will be post-release substance use treatment initiation by 6-months post-release from jail; secondary and exploratory outcomes will include substance use treatment readiness and retention, OUD/STUD severity, PTSD symptoms, victimization, overdose, and additional drug use. Participants in the effectiveness portion of the trial (N = 338; \~50% female) will be enrolled from the largest jail in Arkansas. Jail stakeholders will also be enrolled to provide implementation-related data. The overall goal is to translate research to practice to increase the provision of high-quality care for justice-involved persons with probable PTSD and OUD/STUD. Indeed, this study will be the first trial of a treatment for PTSD in jails as a method for improving OUD/STUD outcomes, providing foundational information on PTSD as a novel intervention target for meeting the needs of a particularly vulnerable population and providing the implementation data to inform rapid scale-up, if effective.
Conditions
- Post-traumatic Stress Disorder (PTSD)
- Post-traumatic Stress Symptoms
- Opioid Use Disorder (OUD)
- Stimulant Use Disorder
- Stimulant Use & Co-occuring Opioid Use Disorders
- Co-occurring Mental and Substance Use Disorders
- Medications for Opioid Use Disorder
Interventions
- OTHER
-
Cognitive Processing Therapy (CPT)
Cognitive Processing Therapy (CPT) is an evidence-based therapy for PTSD that helps people understand how trauma has impacted their life and learn balanced ways to think about the trauma. Participants who choose to pursue CPT will complete worksheets and talk about them with a counselor. CPT will be offered individually; in-person, televideo, and/or phone visits will be acceptable. CPT
- OTHER
-
Written Exposure Therapy (WET)
Written Exposure Therapy (WET) is an evidence-based therapy for PTSD that helps people face memories of trauma so they become less upsetting over time, which can helps people feel more in control of their emotions and reactions. Participants who choose to pursue WET will write about the traumatic event and then talk with a counselor. WET will be offered individually; in-person, televideo, and/or phone visits will be acceptable.
Sponsors & Collaborators
-
National Institute on Drug Abuse (NIDA)
collaborator NIH -
Rush University Medical Center
collaborator OTHER -
University of New Mexico
collaborator OTHER -
Pulaski County Regional Detention Center
collaborator UNKNOWN -
University of Arkansas
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-20
- Primary Completion
- 2029-02-28
- Completion
- 2029-08-31
Countries
- United States
Study Locations
More Related Trials
-
New Beginnings Following Trauma
NCT05817344 ·Status: TERMINATED ·Phase: NA
-
Piloting a Patient-Reported Outcome Measure for Opioid Use Disorder Recovery in a Clinical Setting
NCT05388045 ·Status: UNKNOWN ·Phase: NA
-
CBT4CBT-Buprenorphine + Recovery Coach for Office-based Buprenorphine
NCT04824404 ·Status: COMPLETED ·Phase: NA
-
Integrated Treatment for Opioid Use Disorder and PTSD
NCT06641115 ·Status: RECRUITING ·Phase: NA
-
Patient-Centered Care for Opioid Use Disorders in Federally Qualified Healthcare Centers and Specialty Care Settings
NCT03367234 ·Status: WITHDRAWN ·Phase: NA
-
Clinical Trial of Integrated Treatment for Pain and Opioid Dependence
NCT00634803 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Social Functioning in Opioid Use Disorder
NCT07044466 ·Status: RECRUITING ·Phase: NA
-
Resilience Among Individuals With Opioid Use Disorder
NCT06954402 ·Status: RECRUITING ·Phase: NA
-
Right Tools, Right Time, Right Place: Telehealth for Opioid Use Disorder in Vulnerable Settings
NCT07169409 ·Status: RECRUITING ·Phase: PHASE1
-
Unified Junction of Care, Integrated Treatments and Team Coordination for ADHD in Prison Settings With Substance Use Disorder
NCT07487155 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Telehealth Treatment for Opioid Use Disorders
NCT05832879 ·Status: COMPLETED ·Phase: NA
-
Chronic Pain and Opioid Dependence Assessment and Treatment
NCT00727675 ·Status: COMPLETED ·Phase: NA
-
Stress Response in Opioid Use Disorder
NCT03616379 ·Status: COMPLETED ·Phase: NA
-
CBT4CBT for Office Based Buprenorphine
NCT03580902 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Cognitive-Behavioral Therapy for Pain and Opioid Dependence in Methadone Maintenance Treatment
NCT01334580 ·Status: COMPLETED ·Phase: PHASE1
-
Scalable Digital Delivery of Evidence-based Training for Professionals to Maximize Treatment Rates of OUD in Families
NCT05875142 ·Status: COMPLETED ·Phase: NA
-
Mobile Peer Support for OUD Recovery
NCT05405712 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Integrating Brain, Neurocognitive, and Computational Tools in OUD
NCT06136247 ·Status: RECRUITING
-
Recovery Management Checkups for Opioid Use Disorder Experiment
NCT04365920 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Phase II: Scalable Digital Delivery of CRAFT Training for Professionals to Maximize Treatment Rates of OUD in Families
NCT06685003 ·Status: RECRUITING ·Phase: NA
-
Facilitating Opioid Care Connections
NCT04216719 ·Status: ENROLLING_BY_INVITATION ·Phase: NA
-
Autonomous Digital CBT Intervention for Opioid Use Disorder in Individuals With Co-Occurring Internalizing Disorders
NCT06545071 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Contingency Management for Opioid and Stimulant Use Disorders in Primary Care
NCT05288751 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Collaborating to Heal Addiction and Mental Health in Primary Care
NCT04600414 ·Status: COMPLETED ·Phase: NA
-
Buprenorphine Maintenance for Opioid-Addicted Persons in Jail and Post-Release
NCT00367302 ·Status: COMPLETED ·Phase: PHASE1/PHASE2