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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to improve how clinics manage methadone treatment for individuals with opioid use disorder. It addresses challenges such as decision-making, legal concerns, and financial barriers in providing take-home methadone doses. Several groups of clinics will test this new approach for six months. Patients who have received take-home methadone for at least 30 days may qualify for this trial. As an unphased trial, it offers patients the chance to contribute to innovative solutions that could enhance methadone treatment practices.

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 prior data suggests that this clinic-level multidimensional intervention is safe for opioid use disorder treatment?

Research has shown that a multi-part approach in opioid treatment programs can be safe and effective. Studies have found that these methods improve treatment practices without causing major side effects. For instance, one study found no increase in negative side effects for patients taking methadone, a common treatment for opioid addiction.

Another study in primary care settings demonstrated that these multi-part approaches were both effective and well-tolerated by participants. This suggests that similar methods in opioid treatment programs are likely safe for patients.

Overall, evidence supports that these multi-part approaches are generally well-tolerated, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Multidimensional Intervention for Opioid Use Disorder because it offers a new approach by targeting multiple aspects of treatment simultaneously at the clinic level. Unlike standard treatments that often focus solely on medication-assisted therapy, this intervention includes a comprehensive strategy that may involve behavioral therapies, improved clinic operations, and enhanced patient support. This holistic method aims to improve treatment outcomes by addressing the diverse needs of individuals with opioid use disorder, potentially leading to more sustainable recovery rates.

What evidence suggests that this trial's multidimensional intervention could be effective for opioid use disorder?

Research shows that increasing the use of medication for opioid use disorder (MOUD) can significantly reduce opioid-related harms, such as overdoses. Studies have found that methadone treatment, part of the multidimensional intervention tested in this trial, leads to better outcomes for people with opioid use disorder (OUD). This method not only treats OUD but also helps patients manage their condition more effectively. Additionally, emergency room treatments for OUD show promise when they include reliable referrals and the ability to provide MOUD. However, less than 40% of those who could benefit from MOUD actually receive it. Overall, these findings suggest that using multiple approaches in clinics, as explored in this trial, could improve treatment results by addressing various barriers in OUD care. ^{6 7 8 9 10}

Who Is on the Research Team?

Charles Neighbors, PhD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9175946/

Pharmacological and Behavioral Treatment of Opioid Use ... In patients with comorbid PTSD and OUD, methadone treatment improves OUD outcomes with minimal effects on PTSD symptoms (121). The efficacy of buprenorphine ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7609980/

A systematic review of patients' and providers' perspectives of ... The benefits of increasing MOUD prescriptions to persons with OUD are twofold; they can reduce direct harms of opioids such as opioid overdose, and can treat or ...

3. cdc.gov cdc.gov/overdose-prevention/data-research/facts-stats/moud-study.html

Medications for Opioid Use Disorder (MOUD) Study The MOUD study examined patient outcomes from several opioid use disorder (OUD) treatments.

4. aspe.hhs.gov aspe.hhs.gov/sites/default/files/documents/4da0bd61a6c21dafaf58459b1de79718/ed-interventions-oud.pdf

Emergency Department Interventions for Opioid Use Disorder ED-based efforts to treat OUD work well when they have reliable and accessible referral sources and the ability to provide MOUD. Ongoing ...

5. researchgate.net researchgate.net/publication/328325046_Evidence-based_treatment_for_opioid_use_disorders_A_national_study_of_methadone_dose_levels_2011-2017

A national study of methadone dose levels, 2011–2017 However, less than 40% of people who would benefit from medication for opioid use disorder (MOUD) receive it (Haffajee et al. 2018) and 43% of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10751716/

Retention and critical outcomes among new methadone ... We sought to use electronic health records to compare retention in treatment, opioid use, and adverse events among patients newly entering methadone maintenance ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12515330/

Impact of a Multi-Factorial Primary Care Intervention on ... We found that multi-faceted, evidence-based approaches to improve clinical practice in primary care settings were associated with increased ...

8. aspe.hhs.gov aspe.hhs.gov/reports/models-medication-assisted-treatment-opioid-use-disorder-retention-continuity-care-0

Models for Medication-Assisted Treatment for Opioid Use ... This study sought to identify best practices for retaining individuals in treatment and for achieving continuity of care between settings.

9. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0286859

Clinics Optimizing MEthadone Take-homes for opioid use ... The trial will test intervention effects on OTP-level implementation outcomes and patient outcomes (1) THD use; 2) retention in care; and 3) ...

10. harmreductionjournal.biomedcentral.com harmreductionjournal.biomedcentral.com/articles/10.1186/s12954-021-00488-2

Evaluation of functional status among patients undergoing ... The main objective is comparing the functional status of patients with pharmacological opioid maintenance treatments according to different socio-demographic ...