← Back to Search

Substance Use Treatment for Opioid Use Disorder (ROMI Trial)

N/A
Recruiting
Led By Harold Pollack, PhD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be at least 18 years old
Be older than 18 years old
Must not have
Participants experiencing cognitive impairments that preclude informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Summary

This trial will test different ways of linking recently incarcerated people with a history of opioid use disorder to substance use treatment upon release in the hopes of reducing opioid mortality rates.

Who is the study for?
This trial is for adults over 18 with opioid use disorder (OUD) who live in certain Illinois counties or zip codes. It's not open to those with cognitive impairments that prevent informed consent, residents outside the service area, or anyone previously enrolled in a related JCOIN study.Check my eligibility
What is being tested?
The ROMI study is testing two strategies: Case Management and Peer Recovery support versus Naloxone-Only distribution. The goal is to link individuals released from jails and prisons with substance use treatment for OUD.See study design
What are the potential side effects?
While case management and peer recovery generally do not have medical side effects, naloxone can cause withdrawal symptoms in people dependent on opioids, including body aches, fever, heart palpitations, nervousness, restlessness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am able to understand and give informed consent.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Addiction treatment engagement
Secondary outcome measures
All-cause mortality
Days of Opioid Use
Days of stimulant Use
+10 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Case Management and Peer RecoveryExperimental Treatment1 Intervention
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.
Group II: Naloxone-OnlyPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

Jackson County Sheriff OfficeUNKNOWN
Illinois Department of CorrectionsUNKNOWN
Perfectly Flawed FoundationUNKNOWN

Media Library

Case Management and Peer Recovery Clinical Trial Eligibility Overview. Trial Name: NCT04925427 — N/A
Opioid Use Disorder Clinical Trial 2023: Case Management and Peer Recovery Highlights & Side Effects. Trial Name: NCT04925427 — N/A
Case Management and Peer Recovery 2023 Treatment Timeline for Medical Study. Trial Name: NCT04925427 — N/A
~625 spots leftby Aug 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top