Reducing Opioid Mortality in Illinois
Part of paid clinical trials in Chicago, Illinois.
- Sponsor
- University of Chicago
- Study ID
- NCT04925427
- Status
- Recruiting
Conditions
- Opioid Use
- Opioid-use Disorder
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Case Management and Peer Recovery — BEHAVIORALA 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 — BEHAVIORALParticipants 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.
Study Details
Reducing Opioid Mortality in Illinois (ROMI) is 5-year research study led by the University of Chicago in partnership with the University of Illinois at Chicago's (UIC) Community Outreach Intervention Projects (COIP), the Illinois Criminal Justice Information Authority (ICJIA) and the American Institutes for Research (AIR). ROMI aims to understand and test strategies for linking individuals with a history of opioid use disorder who are released from Illinois jails and prisons to substance use treatment. ROMI is one of twelve grants awarded by the National Institutes of Health (NIH) as part of the Justice Community Opioid Innovation Network (JCOIN) to support research on quality addiction treatment for opioid use disorder in criminal justice settings nationwide.
Key Dates
- Start date
- Aug 10, 2021
- Status verified
- Feb 2024
- Primary completion
- Aug 30, 2026
- Completion
- Aug 30, 2026
Study Design
- Enrollment
- 1,500 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Case Management and Peer RecoveryParticipants 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.
- Placebo Comparator: Naloxone-OnlyParticipants 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.
Primary Outcome Measure
Addiction treatment engagement [ Time Frame: 12 months ]
Central Contacts
- Harold Pollack, PhD773-834-4292
- Mai Pho, MD773-834-3689
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cook County Department of Corrections | Chicago | Illinois | 60608 | |
| Jackson County Jail | Murphysboro | Illinois | 62966 | |
| LaSalle County Jail | Ottawa | Illinois | 61350 | |
| Illinois Department of Corrections | Springfield | Illinois | 62794 | Steve Meeks, MD 312-814-3017 |
| Lake County Sheriff's Office Corrections Division | Waukegan | Illinois | 60085 | Anthony Vega |
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