Substance Use Treatment for Opioid Use Disorder

(ROMI Trial)

Recruiting at 4 trial locations

Overseen By Harold Pollack, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: Cognitive impairments, Reside out of area, others

Compensation: Varies

Number of Visits: 6

Duration: 12 months

1500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find better ways to support individuals with opioid use disorder (OUD) after their release from jail or prison in Illinois. It will test two approaches: one group will receive case management and peer support from those with similar experiences, while another group will learn to use naloxone, a medication that can reverse an opioid overdose. The goal is to determine which method more effectively connects individuals to ongoing substance use treatment. Individuals who have been using opioids without a prescription, or using heroin or synthetic opioids, and live in specific areas, might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative solutions for OUD treatment and support.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that case management and peer recovery programs are well-established and effective. These methods help individuals access substance use treatment and support services. Studies have found that these programs can increase treatment retention, which is encouraging for those considering joining this trial.

Regarding safety, these methods are generally safe because they focus on providing support and guidance rather than using medication or medical procedures. The aim is to help participants overcome obstacles to treatment, such as transportation or housing issues, through regular check-ins and personalized plans.

For the naloxone-only group, naloxone is a medication used to reverse opioid overdoses. The FDA has already approved it for this use, and individuals using it under supervision have not reported serious side effects. The safety of naloxone is well-documented, and it is widely used in communities.

Overall, both case management and peer recovery programs, as well as naloxone, have strong safety records based on existing research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for opioid use disorder because they offer a comprehensive approach beyond the usual focus on medication like methadone or buprenorphine. The "Case Management and Peer Recovery" treatment combines personalized action plans with hands-on support from peers who have lived through similar experiences, aiming to tackle both personal and systemic barriers to recovery. This method not only promotes engagement and retention through regular follow-ups and support but also integrates overdose education and naloxone distribution for harm reduction. Meanwhile, the "Naloxone-Only" approach focuses on immediate overdose prevention with practical training and resource information, offering a critical safety net for those re-entering the community.

What evidence suggests that this trial's treatments could be effective for opioid use disorder?

Research has shown that case management and peer recovery coaching, a treatment option in this trial, can assist individuals with opioid use disorder. Studies have found that this approach encourages greater participation in treatment and helps individuals overcome challenges after leaving jail or prison. Peer recovery coaches, who have faced similar struggles, provide support and guidance, making it easier for individuals to stay on track. Early results suggest that these methods can improve access to treatment and support recovery. By addressing personal challenges and offering customized support, this approach aims to improve outcomes for those dealing with opioid use disorder. ^{1 2 3 4 6}

Who Is on the Research Team?

Harold Pollack, PhD

Principal Investigator

University of Chicago

Mai Pho, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Case Management and Peer Recovery
• Naloxone-Only

Trial Overview 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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Jackson County Sheriff Office

Collaborator

Trials

1

Recruited

1,500+

Illinois Department of Corrections

Collaborator

Trials

1

Recruited

1,500+

Perfectly Flawed Foundation

Collaborator

Trials

1

Recruited

1,500+

LaSalle County Jail

Collaborator

Trials

1

Recruited

1,500+

Lake County Sheriff Office

Collaborator

Trials

1

Recruited

1,500+

Cook County Sheriff Office

Collaborator

Trials

1

Recruited

1,500+

Cook County Health & Hospitals System

Collaborator

Trials

7

Recruited

2,910,000+

Community Outreach Intervention Projects

Collaborator

Trials

1

Recruited

1,500+

Published Research Related to This Trial

Training patients in their homes on how to recognize opioid overdose symptoms and use the Naloxone auto-injector significantly improved their knowledge and response skills, with a statistically significant increase in correct identification of overdose response steps (p = 0.03).

The study faced challenges in feasibility due to insurance coverage issues, as 20 out of 40 enrolled patients withdrew because their insurance did not cover the cost of the Naloxone auto-injector.

NCBI (Pubmed)

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. Dragovich, A., Brason, F., Beltran, T., et al.[2019]

The use of the naloxone autoinjector (NAI) Evzio significantly increased from 218 prescriptions in Year 1 to 2,527 in Year 3, leading to a reduction in fatal opioid overdoses, with 2.5 deaths avoided in Year 3 compared to matched controls.

Despite rising acquisition costs of the NAI, which reached nearly $1.5 million in Year 3, the medical resource savings associated with its use offset these costs, resulting in a net cost of $481,000, demonstrating the economic benefit of timely access to naloxone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Economic impact of a novel naloxone autoinjector on third-party payers. Weiss, RC., Bazalo, GR., Thomson, H., et al.[2015]

A 20-minute telephone-delivered peer recovery support service (PRSS) intervention led to a higher enrollment in medication for opioid use disorder (MOUD) among participants, with 32.5% of PRSS participants enrolling compared to 17.5% in the control group.

Participants receiving PRSS were significantly less likely to experience an opioid overdose (OOD) within 12 months, with only 12.5% reporting an OOD compared to 32.5% in the control group, indicating the potential effectiveness of PRSS in enhancing safety for individuals with opioid use disorder.

NCBI (Pubmed)

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. Winhusen, T., Wilder, C., Kropp, F., et al.[2022]

In a pilot study conducted over 8 weeks in high-risk communities in Chicago, peer outreach workers successfully linked 96% of 70 eligible individuals with opioid use disorders to methadone treatment, demonstrating the effectiveness of this intervention model.

Most participants remained in treatment at 30 and 60 days post-intake (69% and 70%, respectively), indicating that the approach not only facilitates initial access to treatment but also supports ongoing engagement in care.

NCBI (Pubmed)

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. Scott, CK., Grella, CE., Nicholson, L., et al.[2019]

This study will evaluate the effectiveness of behavioral interventions for opioid use disorder (OUD) delivered by certified peer recovery support specialists versus licensed clinical social workers (LCSWs) in a randomized trial involving 650 high-risk patients over 18 months.

The primary goals are to measure how well these interventions promote engagement in OUD treatment within 30 days and reduce recurrent emergency department visits for opioid overdose within 18 months, providing valuable insights into effective treatment strategies.

NCBI (Pubmed)

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. Goedel, WC., Marshall, BDL., Samuels, EA., et al.[2023]

The naloxone auto-injector (EZVIO™), approved by the FDA in 2014, is designed for easy use by anyone, including laypersons, to rapidly administer naloxone during an opioid overdose, potentially saving lives.

This device is safe and portable, requiring minimal instruction for use, and should be made widely available to individuals who may encounter opioid users, emphasizing the importance of quick response in overdose situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of the safety and ease of use of the naloxone auto-injector for the reversal of opioid overdose. Merlin, MA., Ariyaprakai, N., Arshad, FH.[2020]

A new model for treating opioid use disorder (OUD) called the Recovery Community Center Office-Based Opioid Treatment model is proposed to enhance care and reduce overdose risks, building on recent community-based innovations.

The model includes specific protocols for responding to overdose and non-overdose events, but faces potential barriers such as reimbursement issues and regulatory challenges that need to be addressed in future research.

NCBI (Pubmed)

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. Ashford, RD., Brown, AM., McDaniel, J., et al.[2020]

The implementation of a take-home naloxone and peer recovery coach consultation program in emergency departments significantly increased the provision of naloxone to patients at risk of opioid overdose, with over one-third of patients receiving it post-implementation.

The program also improved referrals to treatment for opioid use disorder, increasing from 9.16% to 20.74% after implementation, demonstrating its effectiveness in addressing opioid-related morbidity and mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adoption and Utilization of an Emergency Department Naloxone Distribution and Peer Recovery Coach Consultation Program. Samuels, EA., Baird, J., Yang, ES., et al.[2019]

Emergency department-based peer support programs are effective in connecting individuals with opioid use disorder (OUD) to medication and recovery services, showing promise in addressing the opioid crisis.

The integration of peer support varies across programs, affecting how peers are alerted to potential patients and how they engage with them, highlighting the need for consistent reporting on these methods in future evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emergency department-based peer support for opioid use disorder: Emergent functions and forms. McGuire, AB., Powell, KG., Treitler, PC., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9020165/

Reducing Opioid Mortality in Illinois (ROMI): A Case ... The Reducing Opioid Mortality in Illinois (ROMI) study seeks to test the effectiveness of a critical time intervention (CTI) linking individuals with a history ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S074054722100074X

A case management/peer recovery coaching critical time ... ROMI seeks to test the effectiveness of case management & peer recovery coaching for individuals on release from jail or prison.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11322658/

Peer support for patients with opioid use disorder in the ... In this narrative review, we synthesize the existing evidence on how to develop and implement peer programs for OUD in the ED setting.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04925427

NCT04925427 | Reducing Opioid Mortality in Illinois The investigators will examine the impact of case management and peer recovery coaching on participants' engagement with treatment and harm reduction ...

5. researchgate.net researchgate.net/publication/350015755_Reducing_Opioid_Mortality_in_Illinois_ROMI_A_case_managementpeer_recovery_coaching_critical_time_intervention_clinical_trial_protocol

Reducing Opioid Mortality in Illinois (ROMI) Case management and peer recovery coaching are established interventions that may be leveraged to improve linkage to substance use treatment and ...

6. substanceabusepolicy.biomedcentral.com substanceabusepolicy.biomedcentral.com/articles/10.1186/s13011-021-00342-5

Three-month outcomes from a patient-centered program to ... This study shows preliminary evidence that a care model based on easy and flexible access and strategies to improve treatment retention improves recovery ...