Opioid UseROMINCT04925427
Reducing Opioid Mortality in Illinois
A study testing Case Management and Peer Recovery and Naloxone-Only in people with Opioid Use and Opioid-use Disorder, run by University of Chicago at 5 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Use, Opioid-use Disorder
- What is being tested?
- Case Management and Peer Recovery and Naloxone-Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,500 participants
- Where
- 5 sitesUnited States
- Study dates
- 10 Aug 2021to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participants experiencing cognitive impairments that preclude informed consent.
- Reside out of the service area.
- Prior enrollment in a parallel JCOIN study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites, 5 recruiting
- Not yet recruiting
Cook County Department of Corrections
Chicago, Illinois, 60608
Marianne Kelly, PhD, 773-674-7100, Marianne.Kelly@cookcountyil.gov
- Not yet recruiting
Jackson County Jail
Murphysboro, Illinois, 62966
Jeff Whitbeck, 618-687-2292, Jeff.Whitbeck@jacksoncounty-il.gov
- Recruiting
LaSalle County Jail
Ottawa, Illinois, 61350
Jason Edgcomb, 815-434-8383, jedgcomb@lasallecounty.org
- Not yet recruiting
Illinois Department of Corrections
Springfield, Illinois, 62794
Steve Meeks, MD, 312-814-3017
- Not yet recruiting
Lake County Sheriff's Office Corrections Division
Waukegan, Illinois, 60085
Anthony Vega, AVega@lakecountyil.gov
About this study
Official title: Justice Community Opioid Innovation Network (JCOIN): Reducing Opioid Mortality in Illinois
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.
Read the detailed 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)
- Conditions
- Opioid Use, Opioid-use Disorder
- Being tested
- Case Management and Peer Recovery, Naloxone-Only
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case Management and Peer RecoveryBehavioural
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-OnlyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Naloxone-Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Addiction treatment engagement
Number (%) of participants with two or more addiction treatment provider encounters within three months of study enrollment
Measured: 12 months
Secondary outcomes (13)
Percent of participants enrolled in Medicaid or private insurance
Defined as Medicaid or private insurance enrollment during the intervention period.
Measured: 12 months
Percent of participant utilizing mental health services
Defined as any mental health utilization within 90 days conditional on CAT-MH diagnostic.
Measured: 90 days
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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).
Measured: 12 months
All-cause mortality
Mortality from any cause
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start10 Aug 2021
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Community Outreach Intervention Projects, Cook County Sheriff Office, Cook County Health & Hospitals System, Lake County Sheriff Office, LaSalle County Jail, Perfectly Flawed Foundation, Jackson County Sheriff Office, Illinois Department of Corrections
- Responsible party
- Sponsor
- Investigators
- Harold Pollack, PhD, Principal investigator, University of ChicagoMai Pho, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04925427
- Sponsor's protocol ID
- IRB19-1775
- Acronym
- ROMI
- Status last verified
- Feb 2024
- First submitted
- 5 May 2021
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will adhere to NIH JCOIN approved plan
Publications
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.
PubMed 39586354
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Justice Community Opioid Innovation Network (JCOIN): Reducing Opioid Mortality in Illinois
- ClinicalTrials.gov ID
- NCT04925427
- Acronym / sponsor ID
- ROMI / IRB19-1775
- Conditions
- Opioid Use, Opioid-use Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Community Outreach Intervention Projects, Cook County Sheriff Office, Cook County Health & Hospitals System, Lake County Sheriff Office, LaSalle County Jail, Perfectly Flawed Foundation, Jackson County Sheriff Office, Illinois Department of Corrections
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 14 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case Management and Peer Recovery | Experimental | Behavioral: 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. |
| Naloxone-Only | Placebo comparator | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Participants experiencing cognitive impairments that preclude informed consent.
- Reside out of the service area.
- Prior enrollment in a parallel JCOIN study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Case Management and Peer RecoveryA 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. | Behavioural | Case Management and Peer Recovery |
| Naloxone-OnlyParticipants 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. | Behavioural | Naloxone-Only |
Primary outcome
Addiction treatment engagement
Time frame: 12 months
Number (%) of participants with two or more addiction treatment provider encounters within three months of study enrollment
13 secondary outcomes
Percent of participants enrolled in Medicaid or private insurance
Time frame: 12 months
Percent of participant utilizing mental health services
Time frame: 90 days
Days of Opioid Use
Time frame: 12 months
Days of stimulant Use
Time frame: 12 months
Opioid Use Disorder (OUD) Symptoms
Time frame: 12 months
Stimulant Use Disorder Symptoms
Time frame: 12 months
Patient Reported Outcomes Measurement Information System
Time frame: 12 months
Health services costs
Time frame: 12 months
Re-arrest and Re-incarceration
Time frame: 12 months
Self-reported rate of illegal activity
Time frame: 12 months
Social cost of self reported crime
Time frame: 12 months
Social cost of re-arrest and associated offenses
Time frame: 12 months
All-cause mortality
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Derived from this study: PubMed 39586354Pho 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.
- Individual participant dataSharing planned: Yes. Will adhere to NIH JCOIN approved plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harold Pollack, PhD principal investigator
University of Chicago
Mai Pho, MD principal investigator
University of Chicago
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Case Management and Peer Recovery and Naloxone-Only in people with Opioid Use and Opioid-use Disorder, run by University of Chicago at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Harold Pollack, PhD (773-834-4292, haroldp@uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Addiction treatment engagement (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04925427, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.