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

June 17, 2026 updated by: University of Arkansas
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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
338

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
A2 - Substance Use Treatment Initiation
Time Frame: Through study completion, approximately 1 year
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
A1 - SBIRT-J Acceptability per the Acceptability of Intervention Measure (AIM)
Time Frame: Immediately following the conclusion of Aim 2 enrollment (one-time survey)
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)
Time Frame: Immediately following the conclusion of Aim 2 enrollment (one-time survey)
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
Time Frame: Immediately following the conclusion of Aim 2 enrollment
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)
Time Frame: Immediately following the conclusion of Aim 2 enrollment (one-time survey)
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
Time Frame: Through study completion, approximately 1 year
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
Time Frame: Through study completion, approximately 1 year
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
Time Frame: Through study completion, approximately 1 year
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
Time Frame: Through study completion, approximately 1 year
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
Time Frame: Through study completion, approximately 1 year
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
Time Frame: Through study completion, approximately 1 year
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
Time Frame: Through study completion, approximately 1 year
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
Time Frame: 12 months post-baseline
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
Time Frame: Immediately and until 12 months post-baseline
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
Time Frame: Immediately (baseline-only)
Will be assessed with the Intervention Appropriateness Measure.
Immediately (baseline-only)
A2 - Perceived Acceptability of SBIRT-J
Time Frame: Immediately (baseline-only)
Will be assessed with the Acceptability of Intervention Measure.
Immediately (baseline-only)
A2 - Perceived Appropriateness of Cognitive Processing Therapy (CPT)
Time Frame: Immediately (baseline-only)
Will be assessed with the Intervention Appropriateness Measure.
Immediately (baseline-only)
A2 - Perceived Acceptability of Cognitive Processing Therapy (CPT)
Time Frame: Immediately (baseline-only)
Will be assessed with the Acceptability of Intervention Measure.
Immediately (baseline-only)
A2 - Perceived Appropriateness of Written Exposure Therapy (WET)
Time Frame: Immediately (baseline-only)
Will be assessed with the Intervention Appropriateness Measure.
Immediately (baseline-only)
A2 - Perceived Acceptability of Written Exposure Therapy (WET)
Time Frame: Immediately (baseline-only)
Will be assessed with the Acceptability of Intervention Measure.
Immediately (baseline-only)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Arkansas

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)
Rush University Medical Center
University of New Mexico
Pulaski County Regional Detention Center

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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