Reducing Opioid Mortality in Illinois

Opioid Use Clinical Trial

— ROMI  

Official title:

Justice Community Opioid Innovation Network (JCOIN): Reducing Opioid Mortality in Illinois

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04925427
• Other study ID #: IRB19-1775
• Status: Recruiting
• Phase: N/A
• Start date: August 10, 2021
• Est. completion date: August 30, 2026

Study information

• Verified date: February 2024
• Source: University of Chicago
• Contact: Harold Pollack, PhD
• Phone: 773-834-4292
• Email: haroldp[@]uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This NIDA-funded multi-site randomized control trial (RCT) examines the effectiveness of an established, intensive case management model for study participants who are awaiting release from four jails and two prisons across Illinois. The investigators seek to demonstrate that a unified case management approach can improve treatment engagement and retention among individuals who face high risks of opioid use disorders, overdose, and related harms. The investigators will examine the impact of case management and peer recovery coaching on participants' engagement with treatment and harm reduction interventions. The investigators will also study secondary outcomes including insurance enrollment, re-arrest, use of mental health services, and more.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: August 30, 2026
• Est. primary completion date: August 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants must be at least 18 years old

• 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:

• Participants experiencing cognitive impairments that preclude informed consent.

• Reside out of the service area.

• Prior enrollment in a parallel JCOIN study.

Related Conditions & MeSH terms

• Opioid Use
• Opioid-Related Disorders
• Opioid-use Disorder

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	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

Sponsors (9)

Lead Sponsor	Collaborator
University of Chicago	Community Outreach Intervention Projects, Cook County Health & Hospitals System, Cook County Sheriff Office, Illinois Department of Corrections, Jackson County Sheriff Office, Lake County Sheriff Office, LaSalle County Jail, Perfectly Flawed Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Addiction treatment engagement	Number (%) of participants with two or more addiction treatment provider encounters within three months of study enrollment	12 months
Secondary	Percent of participants enrolled in Medicaid or private insurance	Defined as Medicaid or private insurance enrollment during the intervention period.	12 months
Secondary	Percent of participant utilizing mental health services	Defined as any mental health utilization within 90 days conditional on CAT-MH diagnostic.	90 days
Secondary	Days of Opioid Use	A self-reported count 0 to 90 days of using any kind of opioids each quarter, as indicated by the Global Appraisal of Individual Needs (GAIN)assessment tool.	12 months
Secondary	Days of stimulant Use	A self-reported count 0 to 90 days of using any kind of stimulants each quarter, as indicated by the Global Appraisal of Individual Needs (GAIN)assessment tool.	12 months
Secondary	Opioid Use Disorder (OUD) Symptoms	A self-reported count of Opioid Use Disorder (OUD) symptoms, again as captured by the GAIN instrument, measuring past month, past 90 days, year, and lifetime. SUD/MH symptoms as captured by the CAT-MH/SUD.	12 months
Secondary	Stimulant Use Disorder Symptoms	A self-reported count of Stimulant Use Disorder symptoms, again as captured by the GAIN instrument, measuring past month, past 90 days, year, and lifetime. SUD/MH symptoms as captured by the CAT-MH/SUD.	12 months
Secondary	Patient Reported Outcomes Measurement Information System	This scale of person-centered measures includes eight domains (physical function, ability to participate in social roles and activities, anxiety, depression, fatigue, sleep disturbance, cognitive function ability, pain interference, and pain intensity). These are elicited in a five point likert scale (from 1= never to 5 = always) with higher scores equaling more of the concept being measured, which may be better or worse based on the domain measured.	12 months
Secondary	Health services costs	This cost measure is based on the self-reported frequency of all healthcare services use. Measured using published Medicare reimbursement rates for all pertinent medical care services. Addiction services cost as measured by DATCAP methodology.	12 months
Secondary	Re-arrest and Re-incarceration	Arrest or re-incarceration based on any charge using data from Illinois Criminal Justice Information Authority (ICJIA). The investigators will examine the binary outcomes of re-arrest and reincarceration, and also count data models of the number of arrests post-enrollment during days of non-incarceration.	12 months
Secondary	Self-reported rate of illegal activity	This is a self-reported count of 19 items across different types of illegal activities following the JCOIN core measures instrument.	12 months
Secondary	Social cost of self reported crime	Total social cost of self-reported illegal activity, using estimates for offense-specific economic valuations of social cost per offense and a self-reported count of 19 items across different types of illegal activities.	12 months
Secondary	Social cost of re-arrest and associated offenses	Total social cost of crime, using estimates for offense-specific economic valuations of social cost per offense and any charge using data from Illinois Criminal Justice Information Authority (ICJIA).	12 months
Secondary	All-cause mortality	Mortality from any cause	12 months