Improving methadone take-home dosing for better treatment retention in opioid use disorder
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 318 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 4 sites (Storrs, Connecticut and 3 other locations) |
| Trial ID | NCT05675735 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have been receiving take-home methadone for at least 30 days.
Not a fit: Patients who are not currently receiving take-home methadone or are under 18 years old may not benefit from this study.
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 performed: Other studies have shown promise in improving treatment retention through similar regulatory flexibility approaches, indicating potential for success in this intervention.
Eligibility criteria
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 this trial is running
Storrs, Connecticut and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.