Developing and Testing Innovative Care Pathways for Screening and Treatment of OUD/PTSD in Jails

NCT07490717 | Enrolling By Invitation DMC

• 2 other identifiers: 2986804R33DA059947
• Study Type: interventional
• Target: 338
• Locations: 1 country
• Sites: 2

Brief 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

Co-occurring Mental and Substance Use Disorders; Medications for Opioid Use Disorder; Post-traumatic Stress Disorder (PTSD); Post-traumatic Stress Symptoms; Opioid Use Disorder (OUD); Stimulant Use Disorder; Stimulant Use & Co-occuring Opioid Use Disorders

Keywords

Post-Traumatic Stress Disorder; Trauma; Substance Use Disorders; Opioid Use Disorder; Stimulant Use Disorder; SBIRT; Screening; Brief Intervention; Referral to Treatment; Trauma-Focused Therapy; Cognitive Processing Therapy; Cognitive Processing Therapy for Criminal Justice Setting; Written Exposure Therapy; Criminal Justice; Incarceration; Detention; Jail; Implementation; Implementation Evaluation; Acceptability; Appropriateness; Effectiveness; Evidence-Based Intervention; Individual Therapy; Stakeholders

Outcome Measures

Primary Outcomes (1)

• A2 - Substance Use Treatment Initiation

  Substance use treatment initiation (binary; presence vs absence) will be assessed via participant self-report and verified via medical chart review when possible.

  Through study completion, approximately 1 year

Secondary Outcomes (19)

• A1 - SBIRT-J Acceptability per the Acceptability of Intervention Measure (AIM)

  Immediately following the conclusion of Aim 2 enrollment (one-time survey)

• A1 - SBIRT-J Appropriateness per the Intervention Appropriateness Measure (IAM)

  Immediately following the conclusion of Aim 2 enrollment (one-time survey)

• A1 - SBIRT-J Reach

  Immediately following the conclusion of Aim 2 enrollment

• A1 - SBIRT-J Feasibility per the Feasibility of Intervention Measure (FIM)

  Immediately following the conclusion of Aim 2 enrollment (one-time survey)

• A2 - Retention in Substance Use Treatment

  Through study completion, approximately 1 year

Study Arms (2)

Intervention Arm (Jail-Initiated PTSD Therapy)

EXPERIMENTAL

Following participation in SBIRT-J, individuals who screen positive for both PTSD and OUD/STUD will be invited to participate in the trial. Participants who are randomized to this condition will be referred to begin PTSD therapy as soon as possible, while still in jail. The delivery schedule can be variable to meet participants' needs and preferences. PTSD therapy will be continued post-release if a participant in this condition is released from jail prior to completion (i.e., in cases of earlier-than-expected release) as well as continued if the participant returns to jail while treatment remains ongoing.

Other: Cognitive Processing Therapy (CPT); Other: Written Exposure Therapy (WET)

Control Arm (Community-Initiated PTSD Therapy)

ACTIVE COMPARATOR

Following participation in SBIRT-J, individuals who screen positive for both PTSD and OUD/STUD will be invited to participate in the trial. Participants who are randomized to this condition will be scheduled to begin PTSD Therapy in the community upon release from jail. The delivery schedule for each community-initiated PTSD Therapy can also be variable to meet participants' needs and preferences. This arm is considered the control arm because it is the arm most consistent with usual care in the jail setting (although a somewhat enhanced usual care condition because direct referral to PTSD Therapy is not made or paid for as standard practice-referral to mental health treatment, more generally, is what would be more typical). As in the Jail-Initiated arm, treatment will continue if the participant returns to jail while treatment remains ongoing.

Other: Cognitive Processing Therapy (CPT); Other: Written Exposure Therapy (WET)

Interventions

Cognitive Processing Therapy (CPT) OTHER

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

Control Arm (Community-Initiated PTSD Therapy); Intervention Arm (Jail-Initiated PTSD Therapy)

Written Exposure Therapy (WET) OTHER

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.

Control Arm (Community-Initiated PTSD Therapy); Intervention Arm (Jail-Initiated PTSD Therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Able to understand and speak English
• Able to give informed consent
• Invited by the PI to participate, due to specific role within the project site
• Incarcerated at the study site
• Screened positive for probable PTSD and OUD/STUD as part of the SBIRT-J process
• Have an expected duration of incarceration that is compatible with receiving trauma-focused treatment and completing assessments within the remaining timeline of the study

You may not qualify if:

• Unwilling to consent to randomization
• Unable to provide locator information for post-release assessments
• Currently experiencing psychiatric symptoms that would preclude participation in CPT or WET (e.g., severe behavioral dysregulation, severe psychotic symptoms)

Sponsors & Collaborators

• University of Arkansas: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Rush University Medical Center: collaborator
• University of New Mexico: collaborator
• Pulaski County Regional Detention Center: collaborator

Study Sites (2)

Pulaski County Regional Detention Facility

Little Rock, Arkansas, 72204, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Opioid-Related Disorders; Substance-Related Disorders; Wounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Narcotic-Related Disorders; Chemically-Induced Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 24, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: March 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Indefinitely, as requested/following the publication of primary manuscripts.
• Access Criteria: As aforementioned, information in the research records will be released to requesters, in compliance with NIH's requirements for data sharing. Final research data for this project will be made as available as possible while safeguarding the privacy of participants and protecting all confidential and proprietary data. This will include depositing data into a shared repository. Distribution of data to specific requesting entities will be approved by the IRB in accordance with protection of human subject and HIPAA guidelines following the publication of primary manuscripts. Any shared final data sets will be stripped of personal and/or direct identifiers prior to the release of data sharing and protections will be put in place to prevent persons with any unusual characteristics from being identified.

Locations

US (2)