3440 Participants Needed

OCM-RISE Implementation for Opioid Use Disorder

MR
KS
Overseen ByKatherine S Elkington, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: New York State Psychiatric Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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 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.12345

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.678910

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.611121314

Who Is on the Research Team?

EN

Edward Nunes, MD

Principal Investigator

Columbia University/NYSPI

KS

Katherine S Elkington, PhD

Principal Investigator

Columbia University/NYSPI

ML

Milton L Wainberg, 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?
1Treatment groups
Experimental Treatment
Group I: OCM-RISEExperimental Treatment1 Intervention

Find a Clinic Near You

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

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.
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.
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.
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

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]
Predictors of resolution of aberrant drug behavior in chronic pain patients treated in a structured opioid risk management program. [2009]
Medication Assisted Treatment Program Policies: Opinions of People in Treatment. [2023]
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]
PRimary Care Opioid Use Disorders treatment (PROUD) trial protocol: a pragmatic, cluster-randomized implementation trial in primary care for opioid use disorder treatment. [2022]
Safety and Persistence of Nalmefene Treatment for Alcohol Dependence. Results from Two Post-authorisation Safety Studies. [2021]
Advancing the science for active surveillance: rationale and design for the Observational Medical Outcomes Partnership. [2022]
Monitoring product safety in the postmarketing environment. [2021]
Analysis of adverse events in a dose titration study. [2019]
10.United Statespubmed.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 Statespubmed.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 Statespubmed.ncbi.nlm.nih.gov
Smartphone intervention to optimize medication assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial. [2023]
Responding to the opioid and overdose crisis with innovative services: The recovery community center office-based opioid treatment (RCC-OBOT) model. [2020]
Management of opioid use disorder in the USA: present status and future directions. [2019]
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