Who is eligible for clinical trial NCT05675735?

Participants must meet the protocol's inclusion criteria for Problems Related to Social Environment. The stated age range is 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT05675735 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-10

Leveraging Regulatory Flexibility for Methadone Take-Home Dosing to Improve Retention in Treatment for Opioid Use Disorder (NCT05675735)

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

🟢 Recruiting Observational / Diagnostic 🧠 Behavioral & Psychological Program Sponsor: NYU Langone Health

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (2 items) and avoid the listed exclusions (2 items).

Location: University of Connecticut — Storrs, Connecticut

Age range: 18 Years

🧪 Interventions in This Study

Clinic-Level Multidimensional Intervention (BEHAVIORAL)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (4 Sites)

University of Connecticut — Storrs, Connecticut
University at Buffalo — Buffalo, New York
NYU Langone Health — New York, New York
Weill Cornell Medical College — New York, New York

📞 Contact the Study Coordinator

Phone: (646) 501-3875

Email: Charles.Neighbors@nyulangone.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Problems Related to Social Environment clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗