Improving methadone take-home dosing for better treatment retention in opioid use disorder
Official title: Leveraging Regulatory Flexibility for Methadone Take-Home Dosing to Improve Retention in Treatment for Opioid Use Disorder: A Stepped-Wedge Randomized Trial to Facilitate Clinic Level Changes
Run by NYU Langone Health · NCT05675735 · Data updated 2026-11-12
This study is testing a new way to help people with opioid use disorder get their methadone medication at home more easily, especially focusing on those who face extra challenges, to see if it helps them stay in treatment longer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 318 (estimated) |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 4 sites (Storrs, Connecticut and 3 other locations) |
| Status | Recruiting |
| Started | January 27, 2023 |
| Main results expected | September 1, 2026 |
| Study ends | August 31, 2027 |
| Registry record updated | August 12, 2026 |
| Trial ID | NCT05675735 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older who have been receiving take-home methadone for at least 30 days.
✕Probably not a fit
Patients who are not currently receiving take-home methadone or are under 18 years old may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study tests a clinic-level multidimensional intervention across 36 opioid treatment programs (OTPs) to enhance clinical decision-making and reduce barriers to take-home dosing (THD) of methadone. By leveraging regulatory changes made during the COVID-19 pandemic, the study aims to improve retention in care for individuals with opioid use disorder (OUD). The intervention addresses issues such as regulatory confusion and financial barriers, particularly for Black/African American and Latinx populations who face disparities in care. The effectiveness of this approach will be evaluated through a stepped-wedge randomized controlled trial design.
Why it matters
Potential benefit: If successful, this study could significantly improve retention rates in treatment for opioid use disorder by making methadone more accessible through take-home dosing.
How similar studies have gone: Other studies have shown promise in improving treatment retention through similar regulatory flexibility approaches, indicating potential for success in this intervention.
Who can join: the full rules
Show full inclusion / exclusion criteria
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. * Patient inclusion will include anyone aged 18 or older who has been receiving take-home methadone for at least 30 days. Exclusion Criteria • There are no exclusion criteria related to sex/gender to increase the generalizability of the findings. The investigators will note include children in this study because the treatment system that we are examining largely excludes adolescents and younger children.
Where it's running
-
University of Connecticut
Storrs, Connecticut, United States Recruiting -
University at Buffalo
Buffalo, New York, United States Recruiting -
NYU Langone Health
New York, New York, United States Recruiting -
Weill Cornell Medical College
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Charles Neighbors, PhD — NYU Langone Health
- Study coordinator: Charles Neighbors, PhD
- Email: Charles.Neighbors@nyulangone.org
- Phone: 646-501-3875
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.