NCT04925427

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Aug 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Aug 2021Aug 2026

First Submitted

Initial submission to the registry

May 5, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 14, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

August 10, 2021

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

5.1 years

First QC Date

May 5, 2021

Last Update Submit

February 16, 2024

Conditions

Opioid UseOpioid-use Disorder

Outcome Measures

Primary Outcomes (1)

  • Addiction treatment engagement

    Number (%) of participants with two or more addiction treatment provider encounters within three months of study enrollment

    12 months

Secondary Outcomes (13)

  • Percent of participants enrolled in Medicaid or private insurance

    12 months

  • Percent of participant utilizing mental health services

    90 days

  • Days of Opioid Use

    12 months

  • Days of stimulant Use

    12 months

  • Opioid Use Disorder (OUD) Symptoms

    12 months

  • +8 more secondary outcomes

Study Arms (2)

Case Management and Peer Recovery

EXPERIMENTAL

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.

Behavioral: Case Management and Peer Recovery

Naloxone-Only

PLACEBO COMPARATOR

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.

Behavioral: Naloxone-Only

Interventions

Case Management and Peer RecoveryBEHAVIORAL

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.

Case Management and Peer Recovery
Naloxone-OnlyBEHAVIORAL

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.

Naloxone-Only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Participants experiencing cognitive impairments that preclude informed consent.
  • Reside out of the service area.
  • Prior enrollment in a parallel JCOIN study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Cook County Department of Corrections

Chicago, Illinois, 60608, United States

NOT YET RECRUITING

Jackson County Jail

Murphysboro, Illinois, 62966, United States

NOT YET RECRUITING

LaSalle County Jail

Ottawa, Illinois, 61350, United States

RECRUITING

Illinois Department of Corrections

Springfield, Illinois, 62794, United States

NOT YET RECRUITING

Lake County Sheriff's Office Corrections Division

Waukegan, Illinois, 60085, United States

NOT YET RECRUITING

Related Publications (1)

  • 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.

    PMID: 39586354DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Case Management

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Patient Care PlanningComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Harold Pollack, PhD

    University of Chicago

    PRINCIPAL INVESTIGATOR

  • Mai Pho, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Harold Pollack, PhD

CONTACT

773-834-4292haroldp@uchicago.edu

Mai Pho, MD

CONTACT

773-834-3689mpho@bsd.uchicago.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2021

First Posted

June 14, 2021

Study Start

August 10, 2021

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

February 21, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

Will adhere to NIH JCOIN approved plan

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Will adhere to NIH JCOIN approved plan
Access Criteria
Will adhere to NIH JCOIN approved plan

Locations

US(5)