Multidimensional Intervention for Opioid Use Disorder

Recruiting at 3 trial locations

Overseen By Beth Knopf, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must be taking: Methadone

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

318 Participants Needed

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. ^{1 2 3 4 5}

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. ^{3 4 6 7 8}

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. ^{1 3 9 10 11}

Research Team

Charles Neighbors, PhD

Principal Investigator

NYU Langone Health

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.

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

Treatment Details

Interventions

• Clinic-Level Multidimensional Intervention

Trial Overview 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.

Participant Groups

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

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

From 2017 to 2021, patients in methadone medication treatment for opioid use disorder showed a significant increase in positivity rates for fentanyl, methamphetamine, and cocaine, indicating a rise in polysubstance use among this population.

Despite the increase in other substances, methadone treatment was effective in reducing illicit opioid use, as evidenced by a decline in positivity rates for fentanyl and heroin over the first year of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polydrug use among patients on methadone medication treatment: Evidence from urine drug testing to inform patient safety. Saloner, B., Whitley, P., Dawson, E., et al.[2023]

A systematic review of 27 longitudinal studies on opioid treatment involving over 65,686 participants revealed significant variability in the outcome measures used, which complicates the assessment of treatment effectiveness.

The studies typically reported on less than half of the identified eight outcome domains related to drug use, health, and social functioning, indicating a need for standardized measures to improve replicability and clarity in treatment success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Large variation in measures used to assess outcomes of opioid dependence treatment: A systematic review of longitudinal observational studies. Wiessing, L., Ferri, M., Darke, S., et al.[2019]

This study aims to compare the long-term effectiveness of methadone versus buprenorphine/naloxone for treating opioid use disorder in British Columbia, analyzing data from over a decade (2008-2018) involving adults receiving opioid agonist treatment.

Key outcomes will include retention rates in treatment and all-cause mortality, using robust statistical methods to ensure the reliability of results, which could inform personalized treatment strategies and improve patient-centered care.

NCBI (Pubmed)

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. Piske, M., Thomson, T., Krebs, E., et al.[2021]

The US Department of Veterans Affairs has prioritized increasing access to effective treatments for opioid use disorder (OUD), particularly through the use of medications like buprenorphine, methadone, and injectable naltrexone.

Despite system-wide efforts, the adoption of these medications has been inconsistent across different VA facilities and among vulnerable patient groups, highlighting the need for targeted strategies to improve access and utilization.

NCBI (Pubmed)

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. Wyse, JJ., Gordon, AJ., Dobscha, SK., et al.[2022]

Only 2 out of 31 endorsed quality measures for opioid use disorder (OUD) considered patient preferences and needs, highlighting a significant gap in patient-centered care despite guidelines emphasizing its importance.

The study developed a new quality measurement taxonomy called EQuIITable Care, which includes six classifications aimed at improving patient-centered care in OUD treatment and identifying areas for future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-centered quality measurement for opioid use disorder: Development of a taxonomy to address gaps in research and practice. Kelley, AT., Incze, MA., Baylis, JD., et al.[2023]

There is a significant shortage of opioid treatment programs (OTPs) in the US, leading to racial and geographic inequities in access to methadone treatment for opioid use disorder (OUD).

The Methadone Access Research Task Force has identified six key research areas to improve access and outcomes for methadone treatment, including exploring access in general medical settings and the effectiveness of different treatment structures.

NCBI (Pubmed)

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. Joudrey, PJ., Bart, G., Brooner, RK., et al.[2022]

A new project aims to improve the implementation of take-home dosing (THD) of methadone for opioid use disorder by developing a multidimensional intervention that addresses clinical decision-making and regulatory challenges, particularly benefiting Black and Latinx clients.

The study will involve a two-phase approach, including a mixed methods design to analyze large state data and conduct qualitative interviews, followed by a three-year trial with 36 opioid treatment programs to assess the impact of the intervention on THD use, retention in care, and adverse healthcare events.

NCBI (Pubmed)

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. Choi, S., O'Grady, MA., Cleland, CM., et al.[2023]

From 1996 to 2014, the number of pregnant women entering treatment for opioid use disorder (OUD) increased significantly, yet the percentage receiving pharmacotherapy remained stable at around 50%, indicating a gap in treatment access.

Pharmacotherapy recipients were typically older, more likely to be white, and had different substance use patterns compared to non-recipients, with notable regional disparities in pharmacotherapy utilization, particularly in the South where fewer women received such treatment.

NCBI (Pubmed)

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. Short, VL., Hand, DJ., MacAfee, L., et al.[2019]

In a 40-week clinical trial with 192 participants, high-dose methadone (80-100 mg) significantly reduced the rate of opioid-positive urine samples compared to moderate-dose methadone (40-50 mg), indicating greater efficacy in decreasing illicit opioid use.

Both dosing strategies resulted in similar treatment retention rates, suggesting that while higher doses may be more effective in reducing opioid use, they do not necessarily lead to longer retention in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moderate- vs high-dose methadone in the treatment of opioid dependence: a randomized trial. Strain, EC., Bigelow, GE., Liebson, IA., et al.[2019]

Current methadone clinics operate under two main models: metabolic and psychotherapeutic, both of which have not fully succeeded in treating opiate abuse.

A new model called the social psychiatric is proposed to address the shortcomings of the existing models, potentially offering a more effective approach to opiate addiction therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The methadone clinic: function and philosophy. Graff, H., Ball, JC.[2017]

In a study of 267 patients in a small Midwest community, most reported multiple barriers to retaining methadone treatment, with travel hardships and work conflicts being the most significant obstacles.

Individuals with a history of returning to opioid use and those with severe mental health symptoms faced greater barriers, while higher levels of social support were linked to fewer barriers, suggesting that enhancing support networks could improve treatment retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cumulative barriers to retention in methadone treatment among adults from rural and small urban communities. Pasman, E., Kollin, R., Broman, M., et al.[2022]

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]

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]

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]

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]

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]

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]

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]

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]

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

Moderate- vs high-dose methadone in the treatment of opioid dependence: a randomized trial. [2019]

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

The methadone clinic: function and philosophy. [2017]

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

Cumulative barriers to retention in methadone treatment among adults from rural and small urban communities. [2022]