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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the operation of opioid courts in New York State to better assist individuals with opioid use disorder (OUD). The goal is to refine a new approach called OCM-RISE, which focuses on quickly connecting individuals to medication that can treat OUD and reduce drug overdoses and repeat offenses. The trial will observe and enhance how different counties implement this new court model. Individuals who work for the Unified Court System or in substance use treatment agencies and speak English are well-suited for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative solutions for OUD treatment and court operations.

Will I have to stop taking my current medications?

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

What prior data suggests that the OCM-RISE implementation is safe?

Research has shown that the new Opioid Court Model (OCM) and the related OCM-RISE program aim to help people with opioid use disorder (OUD). However, specific safety information for OCM-RISE itself is not available. This trial is labeled as "Not Applicable" for its phase, indicating a focus on implementing a strategy rather than testing a new drug or medical treatment.

In terms of safety, trials like this one typically assess how well a program works in real-life settings rather than any direct health risks to participants. The goal is to improve and determine how the program can be expanded effectively. Since no new drugs or invasive procedures are involved, the risks are generally lower compared to drug trials. Participants should still be aware of the usual risks of participating in any research study, such as time commitment and privacy concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the OCM-RISE protocol because it offers a novel approach to tackling opioid use disorder by enhancing the effectiveness of opioid courts. Unlike standard treatments that focus mainly on medications like methadone or buprenorphine, OCM-RISE integrates legal and therapeutic strategies, empowering opioid courts to create actionable plans tailored to community needs. This method aims to improve the implementation and outcomes of opioid court programs, potentially leading to more sustainable and widespread recovery solutions.

What evidence suggests that the OCM-RISE intervention is effective for opioid use disorder?

Research has shown that the Opioid Court Model (OCM), which forms the basis of the OCM-RISE program in this trial, holds promise in assisting individuals with opioid use disorder (OUD) by rapidly providing access to medication for OUD (MOUD). A public health study predicted that such programs could reduce nonfatal opioid overdoses by up to 35.2% and fatal overdoses by 36.6% among those with OUD. The model emphasizes quickly connecting individuals to necessary treatments, which is crucial because only a small number of those needing OUD treatment actually receive MOUD. The OCM-RISE program aims to enhance and expand this approach across New York State, potentially aiding many people struggling with opioid addiction. ^{1 2 5 6 7}

Who Is on the Research Team?

Katherine S Elkington, PhD

Principal Investigator

Columbia University/NYSPI

Milton L Wainberg, MD

Principal Investigator

Columbia University/NYSPI

Edward Nunes, MD

Principal Investigator

Columbia University/NYSPI

Are You a Good Fit for This Trial?

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.

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

Employed at substance use (SU) treatment agency

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04216719

Study Details | NCT04216719 | Facilitating Opioid Care ... Main outcome data will be drawn from the UCMS. The research team will determine the clinical effectiveness of OCM RISE by determining differences between ...

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK553166/

Opioid Use Disorder: Evaluation and Management - NCBI - NIH Cognitive behavioral therapy is most effective if combined with medications; however, there are mixed results on its effectiveness.[12][24].

3. cdc.gov cdc.gov/mmwr/volumes/73/wr/mm7325a1.htm

Treatment for Opioid Use Disorder: Population Estimates In 2022, 3.7% of US adults aged ≥18 years needed OUD treatment. Among these, only 25.1% received medications for OUD.

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2817002

Public Health Interventions and Overdose-Related ... The model projected decreases of up to 35.2% in nonfatal and 36.6% in fatal opioid-involved overdoses among persons with OUD.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10993074/

Public Health Interventions and Overdose-Related ... This decision analytical model estimates the projected 3-year association between public health interventions and opioid overdose-related outcomes

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9543602/

The opioid use disorder core outcomes set (OUD–COS) for ... The opioid use disorder core outcomes set (OUD–COS) for treatment research: findings from a Delphi consensus study

7. cdc.gov cdc.gov/overdose-prevention/about/understanding-the-opioid-overdose-epidemic.html

Understanding the Opioid Overdose Epidemic The rise in opioid overdose deaths is shown in three waves, with a slight decrease from 2022 to 2023. From 1999-2023, approximately 806,000 ...