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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Opioid Use Disorder (OUD); Stimulant Use Disorder; Post-traumatic Stress Symptoms; Post-traumatic Stress Disorder (PTSD); Stimulant Use & Co-occuring Opioid Use Disorders; Co-occurring Mental and Substance Use Disorders; Medications for Opioid Use Disorder
• Intervention / Treatment: Other: Cognitive Processing Therapy (CPT); Other: Written Exposure Therapy (WET)

• Study Type: Interventional
• Enrollment (Estimated): 338
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences
    • Little Rock, Arkansas, United States, 72204
      • Pulaski County Regional Detention Facility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria for all participants:

• 18 years of age or older
• Able to understand and speak English
• Able to give informed consent

Inclusion criteria for key stakeholders participating in Aim 1 (additional requirements):

• All items listed in "Inclusion criteria for all participants"
• Invited by the PI to participate, due to specific role within the project site

Inclusion criteria for people incarcerated at the study site completing assessments in Aim 2 (additional requirements):

• All items listed in "Inclusion criteria for all participants"
• 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

Exclusion criteria for people incarcerated at the study site to enroll in the Hybrid trial in Aim 2 (additional requirements):

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm (Jail-Initiated PTSD Therapy); 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); 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.
Active Comparator: Control Arm (Community-Initiated PTSD Therapy); 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
A1 - SBIRT-J Acceptability per the Acceptability of Intervention Measure (AIM)	The extent to which SBIRT-J is perceived as satisfactory by stakeholders. Mean scores on the AIM range from 1-5, with higher scores indicating greater intervention acceptability.	Immediately following the conclusion of Aim 2 enrollment (one-time survey)
A1 - SBIRT-J Appropriateness per the Intervention Appropriateness Measure (IAM)	The extent to which SBIRT-J is perceived by stakeholders as relevant to and compatible with the setting and population. Mean scores on the IAM range from 1-5, with higher scores indicating greater intervention appropriateness.	Immediately following the conclusion of Aim 2 enrollment (one-time survey)
A1 - SBIRT-J Reach	The ratio of people who complete SBIRT-J to the number who are booked in the PCRDF during the study period.	Immediately following the conclusion of Aim 2 enrollment
A1 - SBIRT-J Feasibility per the Feasibility of Intervention Measure (FIM)	The extent to which SBIRT-J is perceived by jail stakeholders as useable. Mean scores on the FIM range from 1-5, with higher scores indicating greater intervention feasibility.	Immediately following the conclusion of Aim 2 enrollment (one-time survey)
A2 - Retention in Substance Use Treatment	Retention in substance use treatment once initiated will be assessed via participant self-report and verified via medical chart review when possible.	Through study completion, approximately 1 year
A2 - Opioid Use Disorder Severity	Opioid use disorder (OUD) severity will be assessed via a DSM-5 checklist of OUD diagnostic criteria; this checklist has a maximum score of 11, with higher scores indicating more severe symptoms and scores of ≥2 indicating symptoms likely to meet criteria for OUD. Scores will be examined as both dichotomous (presence vs. absence) and continuous (total number of symptoms).	Through study completion, approximately 1 year
A2 - Stimulant Use Disorder Severity	Stimulant use disorder (STUD) severity will be assessed via a DSM-5 checklist of STUD diagnostic criteria; this checklist has a maximum score of 11, with higher scores indicating more severe symptoms and scores of ≥2 indicating symptoms likely to meet criteria for STUD. Scores will be examined as both dichotomous (presence vs. absence) and continuous (total number of symptoms).	Through study completion, approximately 1 year
A2 - Opioid Use	Opioid use will be assessed via participant self-report on the 30-Day Timeline Follow Back Interview and will be examined as both a binary variable and a frequency count representing number of days of use.	Through study completion, approximately 1 year
A2 - Stimulant Use	Stimulant use will be assessed via participant self-report on the 30-Day Timeline Follow Back Interview. The total number of days of stimulant use will be calculated and examined as a frequency count.	Through study completion, approximately 1 year
A2 - Overall Drug Use Frequency	Assessed by the Timeline Follow Back Interview. Will be examined as a frequency count (number of days used in the previous 30 days).	Through study completion, approximately 1 year
A2 - Post-Traumatic Stress Disorder (PTSD) Symptom Severity	Per the PTSD Checklist for DSM-5. Will be a continuous score of 0-80, where lower scores indicate lower PTSD symptoms and thus a better treatment outcome.	Through study completion, approximately 1 year
A2 - Drug-Related Crime	Assessed via the Criminal and Legal Activities Form. Will primarily be defined as 1) new arrests for drug charges and 2) new convictions for drug charges and will be examined as both a binary variable (presence or absence of any drug-related crime) and frequency counts (number of new drug charges or convictions).	12 months post-baseline
A2 - Depressive Symptoms	Assessed via the Patient Health Questionnaire-8. Depressive symptoms will be a continuous score of 0-24 where lower scores indicate lower symptom levels and thus a better treatment outcome.	Immediately and until 12 months post-baseline
A2 - Perceived Appropriateness of SBIRT-J	Will be assessed with the Intervention Appropriateness Measure.	Immediately (baseline-only)
A2 - Perceived Acceptability of SBIRT-J	Will be assessed with the Acceptability of Intervention Measure.	Immediately (baseline-only)
A2 - Perceived Appropriateness of Cognitive Processing Therapy (CPT)	Will be assessed with the Intervention Appropriateness Measure.	Immediately (baseline-only)
A2 - Perceived Acceptability of Cognitive Processing Therapy (CPT)	Will be assessed with the Acceptability of Intervention Measure.	Immediately (baseline-only)
A2 - Perceived Appropriateness of Written Exposure Therapy (WET)	Will be assessed with the Intervention Appropriateness Measure.	Immediately (baseline-only)
A2 - Perceived Acceptability of Written Exposure Therapy (WET)	Will be assessed with the Acceptability of Intervention Measure.	Immediately (baseline-only)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): August 31, 2029

Study Registration Dates

• First Submitted: March 5, 2026
• First Submitted That Met QC Criteria: March 18, 2026
• First Posted (Actual): March 24, 2026

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Implementation; Screening; Opioid Use Disorder; Effectiveness; Trauma; Acceptability; Brief Intervention; Post-Traumatic Stress Disorder; SBIRT; Cognitive Processing Therapy; Criminal Justice; Written Exposure Therapy; Referral to Treatment; Substance Use Disorders; Detention; Appropriateness; Individual Therapy; Incarceration; Stakeholders; Evidence-Based Intervention; Jail; Implementation Evaluation; Stimulant Use Disorder; Cognitive Processing Therapy for Criminal Justice Setting; Trauma-Focused Therapy
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Narcotic-Related Disorders; Mental Disorders; Chemically-Induced Disorders; Stress Disorders, Traumatic; Opioid-Related Disorders; Substance-Related Disorders; Wounds and Injuries; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 298680; 4R33DA059947 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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 also 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.
• IPD Sharing Time Frame: Indefinitely, as requested/following the publication of primary manuscripts.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No