Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1500 participants
INTERVENTIONAL
2021-08-10
2026-08-30
Brief Summary
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Detailed Description
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ROMI will enroll at least 300 individuals with opioid disorders in the CMPR group, and at least 300 participants in the naloxone-only across five geographically distinct sites of care. All participants will receive harm reduction resources. The investigators hypothesize that the treatment group will display declines in opioid use, re-arrest, self-reported syringe sharing, and overdose risk behaviors relative to the control groups. The investigators will also examine differences between urban - rural and rural differences in treatment engagement and retention engagement, retention, and downstream outcomes across treatment arms. Aside from demonstrating these treatment impacts, the investigators will guide, document and evaluate ROMI's implementation efforts to ensure consistency across sites across sites and to inform future replication of the model in different settings or for different populations. (Edited 11/27/23 to reflect changes in recruitment from 500 in each treatment arm to 300)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Case Management and Peer Recovery
Participants in the CM/PRC + OEND arm will receive one year of service delivery. During the initial intake interview the CM will identify primary, secondary, and tertiary barriers to treatment initiation and completion, then create an action plan tailored to each client. PRCs with lived SUD or incarceration experience will address recovery barriers, while CMs will focus on service barriers. Where beneficial and desired by the clients, PRCs will accompany clients to provider and select service appointments to promote engagement and retention. CM/PRC teams will provide OEND upon community re-entry. The teams will provide follow-up phone calls and home visits to facilitate service linkages. Contact frequency will depend on clients' individual barriers (e.g., transportation, homelessness), but will include at least weekly in-person or telephone check-ins for first six months, reduced to monthly check-ins after that.
Case Management and Peer Recovery
A blend between a Critical Time Intervention (CTI) case management model and a peer recovery coaching approach. CORI will employ peer-based case management/recovery coaching and other transitional services (e.g., peer navigation) to provide support and service linkages to medication-assisted treatment (MAT) and harm reduction interventions to reduce subsequent opioid use and related harms.
Naloxone-Only
Participants randomized to the Usual care + OEND condition will be trained on naloxone administration by research staff at the time of randomization. Upon community re-entry,they will be given a naloxone kit and information on local resources for harm reduction, SUD treatment, and additional supportive services.
Naloxone-Only
Participants will be trained on naloxone administration, and upon re-entry, they will be given a naloxone kit and information on local resources for harm reduction, SUD treatment, and additional supportive services.
Interventions
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Case Management and Peer Recovery
A blend between a Critical Time Intervention (CTI) case management model and a peer recovery coaching approach. CORI will employ peer-based case management/recovery coaching and other transitional services (e.g., peer navigation) to provide support and service linkages to medication-assisted treatment (MAT) and harm reduction interventions to reduce subsequent opioid use and related harms.
Naloxone-Only
Participants will be trained on naloxone administration, and upon re-entry, they will be given a naloxone kit and information on local resources for harm reduction, SUD treatment, and additional supportive services.
Eligibility Criteria
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Inclusion Criteria
* Reside in designated research site county or zip code
* Satisfy criteria for likely OUD based upon nonmedical use of prescription opioids, heroin, or synthetic opioids.
Exclusion Criteria
* Reside out of the service area.
* Prior enrollment in a parallel JCOIN study.
18 Years
ALL
Yes
Sponsors
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Community Outreach Intervention Projects
UNKNOWN
Cook County Sheriff Office
UNKNOWN
Cook County Health & Hospitals System
OTHER
Lake County Sheriff Office
UNKNOWN
LaSalle County Jail
UNKNOWN
Perfectly Flawed Foundation
UNKNOWN
Jackson County Sheriff Office
UNKNOWN
Illinois Department of Corrections
UNKNOWN
University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Harold Pollack, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Mai Pho, MD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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Cook County Department of Corrections
Chicago, Illinois, United States
Jackson County Jail
Murphysboro, Illinois, United States
LaSalle County Jail
Ottawa, Illinois, United States
Illinois Department of Corrections
Springfield, Illinois, United States
Lake County Sheriff's Office Corrections Division
Waukegan, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Steve Meeks, MD
Role: primary
References
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Pho MT, Bouris A, Carreon ED, Stinnette M, Kaufmann M, Shuman V, Watson DP, Jimenez AD, Powell B, Kaplan C, Zawacki S, Morris S, Garcia J, Hafertepe A, Hafertepe K, Pollack HA, Schneider JA, Boodram B. Implementation strategies to support recovery support workers serving criminal legal involved people who use drugs. J Subst Use Addict Treat. 2025 Feb;169:209583. doi: 10.1016/j.josat.2024.209583. Epub 2024 Nov 23.
Other Identifiers
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IRB19-1775
Identifier Type: -
Identifier Source: org_study_id
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