OCM-RISE Implementation for Opioid Use Disorder

Overseen By Katherine S Elkington, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: New York State Psychiatric Institute

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

3440 Participants Needed

Trial Summary

What is the purpose of this trial?

In response to the opioid crisis in New York State (NYS), where the propose project will take place, the Unified Court System (UCS) developed a new treatment court model - the opioid court model (OCM) - designed around 10 practice guidelines to address the flaws of existing drug courts and reduce overdose (OD), opioid use disorder (OUD), and recidivism via rapid screening and linkage to medication for opioid use disorder (MOUD). In 2018, NYS began to expand the OCM across NYS. Yet, given the innovation of the OCM, the exact barriers to implementation in disparate counties with a range of resources - and the strategies to overcome them - are largely unknown. The research team proposes to integrate evidence-based implementation strategies to refine and evaluate the Opioid Court Model Rigorous Implementation Science for Effectiveness (OCM RISE) intervention, an implementation intervention that will allow the OCM, as framed by the 10 practice guidelines, to be scaled up across NYS.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

What data supports the effectiveness of the treatment OCM-RISE for opioid use disorder?

The research highlights that integrated treatments for opioid use disorder, like opioid agonist therapy with medications such as methadone and buprenorphine, have well-documented benefits. Novel treatments, including injected depot formulations, offer advantages like less frequent dosing and consistent drug levels, which may improve treatment outcomes by reducing burdens associated with traditional oral medications. ^{1 2 3 4 5}

What safety data exists for OCM-RISE or similar treatments?

The safety of medical treatments is often monitored after they are available to the public, as new safety issues can appear that weren't seen during initial testing. The FDA and other agencies use large databases to keep track of any new safety concerns that arise with treatments, and they update safety information as needed. ^{6 7 8 9 10}

How does the OCM-RISE treatment for opioid use disorder differ from other treatments?

The OCM-RISE treatment for opioid use disorder is unique because it integrates innovative approaches like community-based models and peer support, which are not typically part of standard medication treatments like methadone or buprenorphine. This approach aims to address barriers in accessing care and improve treatment retention by involving community resources and support systems. ^{1 11 12 13 14}

Research Team

Edward Nunes, MD

Principal Investigator

Columbia University/NYSPI

Katherine S Elkington, PhD

Principal Investigator

Columbia University/NYSPI

Milton L Wainberg, MD

Principal Investigator

Columbia University/NYSPI

Eligibility Criteria

This trial is for adults over the age of 18 who are employed at substance use treatment agencies or by the Unified Court System/County Court in participating counties. Participants must understand and speak English. There are no specific exclusion criteria listed, meaning a wide range of individuals involved in these systems may participate.

Inclusion Criteria

You can speak and understand English.

I am 18 years old or older.

Employed by the Unified Court System/County Court in participating county

Exclusion Criteria

Not applicable.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Exploratory Phase

Conduct readiness surveys, system mapping exercises, focus groups, and in-depth interviews to assess county context

5 months

Preparation Phase

Prepare a needs assessment report and create an implementation plan for the county

7 months

Implementation Phase

Roll out the OCM with data feedback, support, and facilitation from the research team

18 months

Sustainment Phase

Continue OCM implementation and feedback reports without external facilitation

6-18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• OCM-RISE

Trial Overview The OCM-RISE intervention is being tested to improve the opioid court model (OCM) across New York State. The goal is to address opioid use disorder (OUD), reduce overdoses, and lower recidivism by refining rapid screening processes and linking individuals to medication-assisted treatments more effectively.

Participant Groups

Group I: OCM-RISE Experimental Treatment 1 Intervention

Opioid court team provided external facilitation to generate action plans to develop and roll out or improve practice of the county opioid court.

Who Is Running the Clinical Trial?

New York State Psychiatric Institute

Lead Sponsor

Trials

481

Recruited

154,000+

National Institute of Drug Abuse

Collaborator

Trials

11

Recruited

12,500+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Center for Court Innovation

Collaborator

Trials

3

Recruited

4,100+

New York State Unified Court System

Collaborator

Trials

1

Recruited

3,400+

Center on Addiction

Collaborator

Trials

1

Recruited

3,400+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

Findings from Research

In a study of 195 patients referred to the Opioid Renewal Clinic, 45.6% resolved their aberrant drug-related behaviors (ADRBs) within one year, indicating that a significant portion of patients can successfully manage their behaviors with appropriate support.

Patients with a history of cocaine abuse were five times more likely to fail the program, while having multiple pain diagnoses and being married were associated with better outcomes, suggesting that social support and the complexity of pain may influence treatment success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of resolution of aberrant drug behavior in chronic pain patients treated in a structured opioid risk management program. Meghani, SH., Wiedemer, NL., Becker, WC., et al.[2009]

A study involving 225 participants from medication-assisted treatment (MAT) programs in West Virginia highlighted that most individuals currently in MAT prefer personalized treatment plans and shared decision-making with their healthcare providers.

Participants expressed mixed opinions on policies regarding the duration of MAT, use of marijuana or anti-anxiety medications during treatment, and attendance in peer recovery groups, indicating the need for flexible and individualized approaches to support retention in MAT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication Assisted Treatment Program Policies: Opinions of People in Treatment. Carter, M., Boyd, J., Bennett, T., et al.[2023]

A study involving 35 individuals (19 currently and 16 formerly in treatment) revealed that physical capability, such as managing side effects and pain, significantly impacts retention in medications for opioid use disorder (MOUD).

Motivation was identified as the most critical factor for engagement in MOUD, influenced by personal recognition of addiction, readiness to quit, and the perceived consequences of disengagement, highlighting the need for tailored support strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of the COM-B model to patient barriers and facilitators of retention in medication treatment for opioid use disorder in rural Northeastern United States: A qualitative study. Poulsen, MN., Asdell, PB., Berrettini, W., et al.[2023]

The PROUD trial is testing a collaborative care model in primary care settings to improve treatment access for opioid use disorder (OUD), involving over 170,000 patients across six health care systems.

The trial aims to measure the effectiveness of this model by comparing the number of days patients receive medication for OUD and the reduction in acute health care utilization, providing valuable insights for future OUD management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PRimary Care Opioid Use Disorders treatment (PROUD) trial protocol: a pragmatic, cluster-randomized implementation trial in primary care for opioid use disorder treatment. Campbell, CI., Saxon, AJ., Boudreau, DM., et al.[2022]

The FDA Amendments Act of 2007 led to the creation of a system for monitoring the safety of marketed drugs using automated health care data, highlighting the importance of active surveillance in drug safety.

The Observational Medical Outcomes Partnership, a collaboration between the FDA, academia, and the pharmaceutical industry, aims to improve drug safety surveillance by addressing governance, data access, and methodological challenges through a transparent and innovative approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advancing the science for active surveillance: rationale and design for the Observational Medical Outcomes Partnership. Stang, PE., Ryan, PB., Racoosin, JA., et al.[2022]

The safety profile of medications can change after they are approved for public use, as new safety issues may arise that were not identified during clinical trials.

Regulatory agencies, like the FDA, actively monitor medication safety through various methods, including analyzing adverse experience reports and using large electronic databases to detect potential safety signals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring product safety in the postmarketing environment. Sharrar, RG., Dieck, GS.[2021]

In a dose escalation trial, the relationship between drug dosage and adverse events is complex, as adverse events may not consistently occur at higher doses, highlighting the need for careful analysis of time and dose effects.

For drugs requiring titration, it's crucial to report adverse event incidences based on dosage, timing, and titration pace, as these factors significantly influence the safety profile of the medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of adverse events in a dose titration study. Hsu, PH., Laddu, AR.[2019]

The Hub and Spoke model significantly increased access to buprenorphine for patients with opioid use disorder, reaching 45.48% of patients over 2 years, with 78.85% receiving a prescription after initial intake.

Patients in the program were 2.44 times more likely to receive a buprenorphine prescription compared to those at a site without the Hub and Spoke model, indicating its effectiveness in improving treatment access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

(RE-)AIMing for Rapid Uptake: Pilot Evaluation of a Modified Hub and Spoke Model of Medication for Opioid Use Disorder. Heavey, SC., Beehler, GP., Funderburk, J.[2023]

A study is being conducted to evaluate the effectiveness of the smartphone app OptiMAT as an adjunctive intervention for improving outcomes in medication-assisted treatment (MAT) for opioid use disorder (OUD), particularly among adults in outpatient settings.

The trial will compare opioid misuse rates between participants using OptiMAT alongside their treatment and those receiving standard treatment alone, with results expected to inform future use of the app in rural areas and identify which features of OptiMAT are most beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone intervention to optimize medication assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial. Thompson, RG., Bollinger, M., Mancino, M., et al.[2023]

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]

Medications like methadone, buprenorphine, and extended-release naltrexone are effective in improving outcomes for individuals with opioid use disorder, but their effectiveness is often hindered by challenges in diagnosis, treatment entry, and retention.

There is a critical need to enhance the use of these medications through better training for healthcare professionals and the development of new treatment models to provide personalized care for those affected by opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of opioid use disorder in the USA: present status and future directions. Blanco, C., Volkow, ND.[2019]

References

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

Current and future options for opioid use disorder: a survey assessing real-world opinion of service users on novel therapies including depot formulations of buprenorphine. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Predictors of resolution of aberrant drug behavior in chronic pain patients treated in a structured opioid risk management program. [2009]

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

Medication Assisted Treatment Program Policies: Opinions of People in Treatment. [2023]

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

Application of the COM-B model to patient barriers and facilitators of retention in medication treatment for opioid use disorder in rural Northeastern United States: A qualitative study. [2023]

5. England pubmed.ncbi.nlm.nih.gov

PRimary Care Opioid Use Disorders treatment (PROUD) trial protocol: a pragmatic, cluster-randomized implementation trial in primary care for opioid use disorder treatment. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Safety and Persistence of Nalmefene Treatment for Alcohol Dependence. Results from Two Post-authorisation Safety Studies. [2021]

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

Advancing the science for active surveillance: rationale and design for the Observational Medical Outcomes Partnership. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Monitoring product safety in the postmarketing environment. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Analysis of adverse events in a dose titration study. [2019]

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

Postmarket Safety Outcomes for New Molecular Entity (NME) Drugs Approved by the Food and Drug Administration Between 2002 and 2014. [2019]

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

(RE-)AIMing for Rapid Uptake: Pilot Evaluation of a Modified Hub and Spoke Model of Medication for Opioid Use Disorder. [2023]

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

Smartphone intervention to optimize medication assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial. [2023]

13. 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]

14. England pubmed.ncbi.nlm.nih.gov

Management of opioid use disorder in the USA: present status and future directions. [2019]