Multidimensional Intervention for Opioid Use Disorder

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by Charles Neighbors, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: NYU Langone Health

Must be taking: Methadone

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

Using a stepped-wedge randomized controlled trial, the study will test whether a clinic-level multidimensional intervention conducted in 36 opioid treatment programs (OTPs) will improve clinical decision making, regulatory confusion, legal liability concerns, capacity for clinical practice change, and financial barriers to take- home dosing (THD) for methadone as compared to treatment as usual.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications. It seems focused on those already receiving take-home methadone, so you may not need to stop your current methadone treatment.

What data supports the effectiveness of the drug Methadone Hydrochloride for opioid use disorder?

Methadone is a well-established medication for treating opioid use disorder, as it helps reduce withdrawal symptoms and cravings, allowing patients to focus on recovery. Research shows that methadone is effective in reducing opioid-related mortality and improving treatment retention rates.

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Is methadone safe for treating opioid use disorder?

Methadone has been used for many years to treat opioid use disorder and is generally considered safe when prescribed and monitored by healthcare professionals. However, it requires careful management to avoid potential side effects and ensure safe use, especially in specific populations like pregnant women.

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How is the drug Methadone Hydrochloride unique in treating opioid use disorder?

Methadone Hydrochloride is unique because it is often used in higher doses than other treatments, and it is available in both specialized clinics and office-based practices, which can help improve access and personalized care for patients with opioid use disorder.

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Eligibility Criteria

This trial is for staff at selected opioid treatment programs and patients aged 18 or older who have been on take-home methadone for over 30 days. It's open to all genders but excludes children, as the treatment system being studied mainly serves adults.

Inclusion Criteria

Clinic staff inclusion will include anyone who works at the 10 clinics that the OASAS client data system generates from the quantitative analysis in year one. In years 2-5, clinics chosen by the OASAS client data system will be placed into six cohorts. Only staff from these clinics will be eligible.

I am 18 or older and have been taking methadone at home for at least 30 days.

Exclusion Criteria

My gender does not affect my eligibility for this trial.

I am an adult participating in this study.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Development

Development and refinement of the multidimensional OTP intervention using mixed methods

12 months

Stepped-Wedge Trial

Conducting a stepped-wedge trial with 36 OTPs in 6 cohorts, each undergoing a six-month intervention

36 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention

6 months

Participant Groups

The study tests a clinic-level intervention in opioid treatment programs to see if it improves decision making and reduces barriers to methadone take-home dosing compared to usual care, using a stepped-wedge randomized controlled design.

Group I: Cohort 6 Experimental Treatment 1 Intervention

6 of the 36 recruited opioid treatment programs (OTPs) will be enrolled in Cohort 5. Cohort 5 will start the six-month intervention at Month 30 and end at Month 36.

Group II: Cohort 5 Experimental Treatment 1 Intervention

6 of the 36 recruited opioid treatment programs (OTPs) will be enrolled in Cohort 5. Cohort 5 will start the six-month intervention at Month 24 and end at Month 30.

Group III: Cohort 4 Experimental Treatment 1 Intervention

6 of the 36 recruited opioid treatment programs (OTPs) will be enrolled in Cohort 4. Cohort 4 will start the six-month intervention at Month 18 and end at Month 24.

Group IV: Cohort 3 Experimental Treatment 1 Intervention

6 of the 36 recruited opioid treatment programs (OTPs) will be enrolled in Cohort 3. Cohort 3 will start the six-month intervention at Month 12 and end at Month 18.

Group V: Cohort 2 Experimental Treatment 1 Intervention

6 of the 36 recruited opioid treatment programs (OTPs) will be enrolled in Cohort 2. Cohort 2 will start the six-month intervention at Month 6 and end at Month 12.

Group VI: Cohort 1 Experimental Treatment 1 Intervention

6 of the 36 recruited opioid treatment programs (OTPs) will be enrolled in group 1. Group 1 will start the six-month intervention at Baseline and end at Month 6.

Clinic-Level Multidimensional Intervention is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Methadone for:

• Opioid use disorder
• Pain management

🇪🇺 Approved in European Union as Methadone for:

• Opioid dependence
• Severe pain

🇨🇦 Approved in Canada as Methadone for:

• Opioid use disorder
• Chronic pain

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University at Buffalo Buffalo, NY

University of Connecticut Storrs, CT

Weill Cornell Medical College New York, NY

NYU Langone Health New York, NY

Who Is Running the Clinical Trial?

NYU Langone Health Lead Sponsor

National Institutes of Health (NIH) Collaborator

References

1. England pubmed.ncbi.nlm.nih.gov

Polydrug use among patients on methadone medication treatment: Evidence from urine drug testing to inform patient safety. [2023] Patients in methadone medication treatment for opioid use disorder (M-MOUD) typically have a complex history of opioid use, often in combination with other drugs. It is unknown how frequently M-MOUD patients experience persistent substance or polysubstance use. We measured trends in illicit substance use in a large, multistate population of M-MOUD patients and persistence of substance use in the first year of treatment.

2. Australia pubmed.ncbi.nlm.nih.gov

Large variation in measures used to assess outcomes of opioid dependence treatment: A systematic review of longitudinal observational studies. [2019] Treatment outcomes for drug users are critical for informing policy and therapeutic practice. The coherence of outcomes, changes and drug use measures from observational studies on opioid use treatment were reviewed.

3. England pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of buprenorphine-naloxone versus methadone for treatment of opioid use disorder: a population-based observational study protocol in British Columbia, Canada. [2021] Despite a recent meta-analysis including 31 randomised controlled trials comparing methadone and buprenorphine for the treatment of opioid use disorder, important knowledge gaps remain regarding the long-term effectiveness of different treatment modalities across individuals, including rigorously collected data on retention rates and other treatment outcomes. Evidence from real-world data represents a valuable opportunity to improve personalised treatment and patient-centred guidelines for vulnerable populations and inform strategies to reduce opioid-related mortality. Our objective is to determine the comparative effectiveness of methadone versus buprenorphine/naloxone, both overall and within key populations, in a setting where both medications are simultaneously available in office-based practices and specialised clinics.

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

Medications for opioid use disorder in the Department of Veterans Affairs (VA) health care system: Historical perspective, lessons learned, and next steps. [2022] The US Department of Veterans Affairs (VA), the largest health care system in the US, has been confronted with the health care consequences of opioid disorder (OUD). Increasing access to quality OUD treatment, including pharmacotherapy, is a priority for the VA. We examine the history of medications (e.g., methadone, buprenorphine, injectable naltrexone) used in the treatment of OUD within VA, document early and ongoing efforts to increase access and build capacity, primarily through the use of buprenorphine, and summarize research examining barriers and facilitators to prescribing and medication receipt. We find that there has been a slow but steady increase in the use of medications for OUD and, despite system-wide mandates and directives, uneven uptake across VA facilities and within patient sub-populations, including some of those most vulnerable. We conclude with recommendations intended to support the greater use of medication for OUD in the future, both within VA as well as other large health care systems.

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

Patient-centered quality measurement for opioid use disorder: Development of a taxonomy to address gaps in research and practice. [2023] Background: Evidence-based treatment is provided infrequently and inconsistently to patients with opioid use disorder (OUD). Treatment guidelines call for high-quality, patient-centered care that meets individual preferences and needs, but it is unclear whether current quality measures address individualized aspects of care and whether measures of patient-centered OUD care are supported by evidence. Methods: We conducted an environmental scan of OUD care quality to (1) evaluate patient-centeredness in current OUD quality measures endorsed by national agencies and in national OUD treatment guidelines; and (2) review literature evidence for patient-centered care in OUD diagnosis and management, including gaps in current guidelines, performance data, and quality measures. We then synthesized these findings to develop a new quality measurement taxonomy that incorporates patient-centered aspects of care and identifies priority areas for future research and quality measure development. Results: Across 31 endorsed OUD quality measures, only two measures of patient experience incorporated patient preferences and needs, while national guidelines emphasized providing patient-centered care. Among 689 articles reviewed, evidence varied for practices of patient-centered care. Many practices were supported by guidelines and substantial evidence, while others lacked evidence despite guideline support. Our synthesis of findings resulted in EQuIITable Care, a taxonomy comprised of six classifications: (1) patient Experience and engagement, (2) Quality of life; (3) Identification of patient risks; (4) Interventions to mitigate patient risks; (5) Treatment; and (6) Care coordination and navigation. Conclusions: Current quality measurement for OUD lacks patient-centeredness. EQuIITable Care for OUD provides a roadmap to develop measures of patient-centered care for OUD.

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

Research priorities for expanding access to methadone treatment for opioid use disorder in the United States: A National Institute on Drug Abuse Center for Clinical Trials Network Task Force report. [2022] In the US, methadone treatment can only be provided to patients with opioid use disorder (OUD) through federal and state-regulated opioid treatment programs (OTPs). There is a shortage of OTPs, and racial and geographic inequities exist in access to methadone treatment. The National Institute on Drug Abuse Center for Clinical Trials Network convened the Methadone Access Research Task Force to develop a research agenda to expand and create more equitable access to methadone treatment for OUD. This research agenda included mechanisms that are available within and outside the current regulations. The task force identified 6 areas where research is needed: (1) access to methadone in general medical and other outpatient settings; (2) the impact of methadone treatment setting on patient outcomes; (3) impact of treatment structure on outcomes in patients receiving methadone; (4) comparative effectiveness of different medications to treat OUD; (5) optimal educational and support structure for provision of methadone by medical providers; and (6) benefits and harms of expanded methadone access. In addition to outlining these research priorities, the task force identified important cross-cutting issues, including the impact of patient characteristics, treatment, and treatment system characteristics such as methadone formulation and dose, concurrent behavioral treatment, frequency of dispensing, urine or oral fluid testing, and methods of measuring clinical outcomes. Together, the research priorities and cross-cutting issues represent a compelling research agenda to expand access to methadone in the US.

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

Clinics Optimizing MEthadone Take-homes for opioid use disorder (COMET): Protocol for a stepped-wedge randomized trial to facilitate clinic level changes. [2023] Regulatory changes made during the COVID-19 public health emergency (PHE) that relaxed criteria for take-home dosing (THD) of methadone offer an opportunity to improve quality of care with a lifesaving treatment. There is a pressing need for research to study the long-term effects of the new PHE THD rules and to test data-driven interventions to promote more effective adoption by opioid treatment programs (OTPs). We propose a two-phase project to develop and test a multidimensional intervention for OTPs that leverages information from large State administrative data.

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

Trends and disparities in receipt of pharmacotherapy among pregnant women in publically funded treatment programs for opioid use disorder in the United States. [2019] To describe differences in geographic, demographic, treatment, and substance use characteristics by pharmacotherapy receipt among pregnant women entering publically funded treatment for opioid use disorder (OUD) in the United States.

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

Moderate- vs high-dose methadone in the treatment of opioid dependence: a randomized trial. [2019] Methadone hydrochloride treatment is the most common pharmacological intervention for opioid dependence, and recent interest has focused on expanding methadone treatment availability beyond traditional specially licensed clinics. However, despite recommendations regarding effective dosing of methadone, controlled clinical trials of higher-dose methadone have not been conducted.

10. England pubmed.ncbi.nlm.nih.gov

The methadone clinic: function and philosophy. [2017] Currently, methadone clinics are organised within two models, the metabolic and the psychotherapeutic. These models are seen to lack a completely successful opiate abuse therapy. A new model, the social psychiatric, is proposed to correct the deficiencies of these first two.

11. England pubmed.ncbi.nlm.nih.gov

Cumulative barriers to retention in methadone treatment among adults from rural and small urban communities. [2022] Though methadone has been shown to effectively treat opioid use disorder, many barriers prevent individuals from accessing and maintaining treatment. Barriers are prevalent in less populated areas where treatment options are limited. This study examines barriers to retention in methadone treatment in a small Midwest community and identifies factors associated with greater endorsement of barriers.