Substance Use Treatment for Opioid Use Disorder

(ROMI Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen by Harold Pollack, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Chicago

Disqualifiers: Cognitive impairments, Reside out of area, others

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Case Management and Peer Recovery, Case Management and Peer Recovery Coaching, Critical Time Intervention, Naloxone-Only, Narcan, Evzio for opioid use disorder?

Research shows that peer recovery support services can help increase enrollment in medication for opioid use disorder and reduce recurring overdoses. Additionally, programs that distribute naloxone (a medication that can reverse opioid overdoses) and involve peer recovery coaches have been adopted in emergency departments to help prevent opioid-related deaths.

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Is the naloxone auto-injector safe for use in humans?

The naloxone auto-injector, approved by the FDA, is considered safe for use by anyone, including patients, family members, and bystanders, to reverse opioid overdoses. It is designed to be easy to use with auditory and visual instructions, and it is recommended to seek further medical care after its use.

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How is the Case Management and Peer Recovery treatment for opioid use disorder different from other treatments?

This treatment is unique because it combines case management and peer recovery coaching with naloxone distribution, focusing on engaging individuals in recovery through peer support and emergency department interventions, which is not commonly emphasized in other treatments.

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Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

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

I am able to understand and give informed consent.

Prior enrollment in a parallel JCOIN study.

Reside out of the service area

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intensive case management and peer recovery coaching for one year, including weekly check-ins for the first six months, then monthly check-ins.

12 months

Weekly in-person or telephone check-ins for 6 months, then monthly

Follow-up

Participants are monitored for treatment engagement, opioid use, and other outcomes after treatment

12 months

Participant Groups

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.

Group I: Case Management and Peer Recovery Experimental Treatment 1 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-Only Placebo Group 1 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.

Case Management and Peer Recovery is already approved in United States for the following indications:

🇺🇸 Approved in United States as Case Management and Peer Recovery Coaching for:

• Opioid Use Disorder
• Substance Abuse Treatment

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

LaSalle County Jail Ottawa, IL

Jackson County Jail Murphysboro, IL

Illinois Department of Corrections Springfield, IL

Cook County Department of Corrections Chicago, IL

More Trial Locations

Who Is Running the Clinical Trial?

University of Chicago Lead Sponsor

Jackson County Sheriff Office Collaborator

Illinois Department of Corrections Collaborator

Perfectly Flawed Foundation Collaborator

LaSalle County Jail Collaborator

Lake County Sheriff Office Collaborator

Cook County Sheriff Office Collaborator

Cook County Health & Hospitals System Collaborator

Community Outreach Intervention Projects Collaborator

References

1. Ireland pubmed.ncbi.nlm.nih.gov

A brief telephone-delivered peer intervention to encourage enrollment in medication for opioid use disorder in individuals surviving an opioid overdose: Results from a randomized pilot trial. [2022] Medication for opioid use disorder (MOUD) can decrease the risk of opioid overdose (OOD) in individuals with opioid use disorder. Peer recovery support services (PRSS) are increasingly used to promote MOUD engagement but evidence of their efficacy is limited. This study's objective was to evaluate a single 20-minute telephone-delivered PRSS intervention for increasing MOUD enrollment and decreasing recurring OODs.

2. United States pubmed.ncbi.nlm.nih.gov

Adoption and Utilization of an Emergency Department Naloxone Distribution and Peer Recovery Coach Consultation Program. [2019] Rising rates of opioid overdose deaths require innovative programs to prevent and reduce opioid-related morbidity and mortality. This study evaluates adoption, utilization, and maintenance of an emergency department (ED) take-home naloxone and peer recovery coach consultation program for ED patients at risk of opioid overdose.

3. England pubmed.ncbi.nlm.nih.gov

Responding to the opioid and overdose crisis with innovative services: The recovery community center office-based opioid treatment (RCC-OBOT) model. [2020] Opioid use disorder (OUD) and opioid-related overdose mortality are major public health concerns in the United States. Recently, several community-based and professional innovations - including hybrid recovery community organizations, peer-based emergency department warm handoff programs, emergency department buprenorphine induction, and low-threshold OUD treatment programs - have emerged or expanded in an effort to address significant obstacles to providing patients the care needed for OUD and to reduce the risk of overdose. Additional innovations are needed to address the crisis. Building upon the foundational frameworks of each of these recent innovations, a new model of OUD pharmacotherapy is proposed and discussed: the Recovery Community Center Office-Based Opioid Treatment model. Additionally, two potential implementation scenarios, the overdose and non-overdose event protocols, are detailed for communities, peers, and practitioners interested in implementing the model. Potential barriers to implementation of the model include service reimbursement, licensing regulations, and organizational concerns. Future research should seek to validate the model and to identify actual implementation and sustainability barriers and best practices.

4. England pubmed.ncbi.nlm.nih.gov

Randomised clinical trial of an emergency department-based peer recovery support intervention to increase treatment uptake and reduce recurrent overdose among individuals at high risk for opioid overdose: study protocol for the navigator trial. [2023] Effective approaches to increase engagement in treatment for opioid use disorder (OUD) and reduce the risk of recurrent overdose and death following emergency department (ED) presentation for opioid overdose remain unknown. As such, we aim to compare the effectiveness of behavioural interventions delivered in the ED by certified peer recovery support specialists relative to those delivered by licensed clinical social workers (LCSWs) in promoting OUD treatment uptake and reducing recurrent ED visits for opioid overdose.

5. United States pubmed.ncbi.nlm.nih.gov

Opioid recovery initiation: Pilot test of a peer outreach and modified Recovery Management Checkup intervention for out-of-treatment opioid users. [2019] The recent surge in opioid-related overdoses and related fatalities underscores the need for assertive mechanisms for linking individuals with opioid use disorders (OUD) to medication-assisted treatment (MAT). This pilot study investigated the feasibility of an intervention that used peer outreach workers to identify out-of-treatment individuals with OUD combined with a modified version of the Recovery Management Checkup to link individuals to methadone treatment. The study was conducted in high-risk communities in Chicago over 8weeks; peer outreach workers identified 88 active opioid/heroin users; 72 were screened as eligible, and 70 showed to the study intake/initial linkage meeting. Most participants were male (73%) and African American (94%), with an average age of 52.0 (sd=7.6). Nearly all (67/70, 96%) were admitted to methadone treatment; median time from initial linkage meeting to treatment admission was 2.6days. Most were still in treatment at 30 and 60days post-intake (69% and 70%, respectively). A high-risk sub-group was identified that had ever received naloxone for an opioid overdose; they had one third of the odds of being in treatment at 30days post-intake compared with others. The intervention model holds promise as an assertive method for identifying and engaging individuals with OUD into treatment.

6. New Zealand pubmed.ncbi.nlm.nih.gov

Assessment of the safety and ease of use of the naloxone auto-injector for the reversal of opioid overdose. [2020] Over the last decade, opioid-related deaths in the United States have increased at an alarming rate. The use of naloxone by laypersons is a newer concept and its utilization can benefit patients by rapid administration due to it being readily available immediately after an opioid overdose. The US Food and Drug Administration approved a naloxone auto-injector on April 3, 2014 for adults and pediatrics, designed for use by anyone including patients, family members, bystanders, and medical professionals. This device (EZVIO™) is the first device of its kind available on the market. The auto-injector is a battery-operated disposable 0.4 mg/0.4 mL prefilled device for use in the lateral thigh by patients, bystanders, or health care professionals. It utilizes auditory and visual commands for ease of administration and instructs patients to seek further medical care after injection. EVZIO costs about $600 for two auto-injectors and a trainer. Additionally, in August 2013, the Substance Abuse and Mental Health Services Administration introduced the Opioid Overdose Toolkit, a federal resource promoting safety and prevention information. This extensive document provides information for medical professionals, first responders, patients, caregivers, and overdose survivors. It outlines many strategies for dealing with this health care crisis. Most importantly, it highlights the importance of rapid recognition and treatment of opioid overdoses as well as routine conversations with patients assessing the need for naloxone prescriptions. The auto-injector is a safe, portable device with limited instruction needed and should routinely be made available to anyone who has contact with an opioid user.

7. England pubmed.ncbi.nlm.nih.gov

The feasibility of employing a home healthcare model for education and treatment of opioid overdose using a naloxone auto-injector in a private practice pain medicine clinic. [2019] The purpose of this study was to determine if employing a home healthcare model for education and treatment of opioid overdose using the Evzio (Naloxone) auto-injector in a private practice pain clinic.

8. United States pubmed.ncbi.nlm.nih.gov

Economic impact of a novel naloxone autoinjector on third-party payers. [2015] Patient overdoses on prescription opioid analgesics in the United States continue to rise, resulting in increased emergency department and hospitalization costs. Opioid overdose is readily reversible with naloxone, a fast-acting opioid antagonist. A new naloxone autoinjector (NAI), Evzio, which does not require medical training to use, was approved by the FDA in April 2014. Payers must decide on reimbursement policies for this product.

9. United States pubmed.ncbi.nlm.nih.gov

Emergency department-based peer support for opioid use disorder: Emergent functions and forms. [2021] Emergency department (ED)-based peer support programs aimed at linking persons with opioid use disorder (OUD) to medication for addiction treatment and other recovery services are a promising approach to addressing the opioid crisis. This brief report draws on experiences from three states' experience with such programs funded by the SAMHSA Opioid State Targeted Repose (STR) grants. Core functions of such programs include: Integration of peer supports in EDs; Alerting peers of eligible patients and making the patient aware of peer services; and connecting patients with recovery services. Qualitative data were analyzed using a general inductive approach conducted in 3 steps in order to identify forms utilized to fulfill these functions. Peer integration differed in terms of peer's physical location and who hired and supervised peers. Peers often depend on ED staff to alert them to potential patients while people other than the peers often first introduce potential patients to programming. Programs generally schedule initial appointments for recovery services for patients, but some programs provide a range of other services aimed at supporting participation in recovery services. Future effectiveness evaluations of ED-based peer support programs for OUD should consistently report on forms used to fulfill core functions.