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

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. ^{1 2 3 4 5}

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. ^{2 4 6 7 8}

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. ^{1 2 4 5 9}

Research Team

Harold Pollack, PhD

Principal Investigator

University of Chicago

Mai Pho, MD

Principal Investigator

University of Chicago

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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

Adoption and Utilization of an Emergency Department Naloxone Distribution and Peer Recovery Coach Consultation Program. [2019]

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]

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]

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]

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]

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]

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

Economic impact of a novel naloxone autoinjector on third-party payers. [2015]

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

Emergency department-based peer support for opioid use disorder: Emergent functions and forms. [2021]