NCT05675735 Leveraging Regulatory Flexibility for Methadone Take-Home Dosing to Improve Retention in Treatment for Opioid Use Disorder
| NCT ID | NCT05675735 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Problems Related to Social Environment |
| Study Type | INTERVENTIONAL |
| Enrollment | 318 participants |
| Start Date | 2023-01-27 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 318 participants in total. It began in 2023-01-27 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Charles Neighbors, PhD
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT05675735 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Problems Related to Social Environment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05675735 currently recruiting?
Yes, NCT05675735 is actively recruiting participants. Contact the research team at Charles.Neighbors@nyulangone.org for enrollment information.
Where is the NCT05675735 trial being conducted?
This trial is being conducted at Storrs, United States, Buffalo, United States, New York, United States, New York, United States.
Who is sponsoring the NCT05675735 clinical trial?
NCT05675735 is sponsored by NYU Langone Health. The principal investigator is Charles Neighbors, PhD at NYU Langone Health. The trial plans to enroll 318 participants.