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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

ROMI Trial 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.

ROMI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

ROMI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

ROMI 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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jackson County Sheriff OfficeUNKNOWN

Perfectly Flawed FoundationUNKNOWN

Illinois Department of CorrectionsUNKNOWN

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the goal of this research endeavor?

"This medical trial's primary outcome will be documented over the course of 12 months, with a focus on the percentage of participants that visit two or more MOUD service providers. Additionally, secondary objectives include evaluating Medicaid and private insurance enrollment during this period, as well as determining the proportion of patients utilizing mental health services within 90 days conditional on CAT-MH diagnostic results."

Answered by AI

Are there any open enrollment slots for this trial?

"Affirmative. Per clinicaltrials.gov, the trial first publicized on August 10th 2021 is presently in progress and requires 1500 participants who will be recruited from 5 different medical facilities."

Answered by AI

How many participants are partaking in this medical study?

"Affirmative, the data on clinicaltrials.gov showcase that this research is actively enrolling participants. This trial was first published on August 10th 2021 and its details were most recently altered October 6th 2021. 1500 patients across 5 different medical sites are currently sought after for participation in the study."

Answered by AI

In what number of locations is this experiment taking place?

"In total, 5 correctional facilities are participating in the clinical trial. These include Illinois Department of Corrections in Springfield, Cook County Department of Corrections in Chicago and Lake County Sheriff's Office Corrections Division in Waukegan. There are also 2 other locations that can join the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Reducing Opioid Mortality in Illinois

2021. "Reducing Opioid Mortality in Illinois". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04925427.