RecruitingNot Applicable

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

United States318 participantsStarted 2023-01-27

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from Baseline in 7-Day THD Prescriptions

Timeframe: Pre-Intervention (from Baseline up to Month 30), Post-Intervention (from Month 6 up to Month 36)

Change from Baseline in 14-Day THD Prescriptions

Timeframe: Pre-Intervention (from Baseline up to Month 30), Post-Intervention (from Month 6 up to Month 36)

Change from Baseline in 28-Day THD Prescriptions

Timeframe: Pre-Intervention (from Baseline up to Month 30), Post-Intervention (from Month 6 up to Month 36)

Change from Baseline in OTP Care Retention

Timeframe: Pre-Intervention (from Baseline up to Month 30), Post-Intervention (from Month 6 up to Month 36)

Change from Baseline in Number of Emergency Department Visits

Timeframe: Pre-Intervention (from Baseline up to Month 30), Post-Intervention (from Month 6 up to Month 36)

Change from Baseline in Number of Hospitalizations

Timeframe: Pre-Intervention (from Baseline up to Month 30), Post-Intervention (from Month 6 up to Month 36)

Trial details

NCT IDNCT05675735

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-01

Contact for this trial

Charles Neighbors, PhD

646-501-3875 Charles.Neighbors@nyulangone.org

View on ClinicalTrials.gov More Problems Related to Social Environment trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change from Baseline in 7-Day THD Prescriptions

Timeframe: Pre-Intervention (from Baseline up to Month 30), Post-Intervention (from Month 6 up to Month 36)

Change from Baseline in 14-Day THD Prescriptions

Timeframe: Pre-Intervention (from Baseline up to Month 30), Post-Intervention (from Month 6 up to Month 36)

Change from Baseline in 28-Day THD Prescriptions

Timeframe: Pre-Intervention (from Baseline up to Month 30), Post-Intervention (from Month 6 up to Month 36)

Change from Baseline in OTP Care Retention

Timeframe: Pre-Intervention (from Baseline up to Month 30), Post-Intervention (from Month 6 up to Month 36)

Change from Baseline in Number of Emergency Department Visits

Timeframe: Pre-Intervention (from Baseline up to Month 30), Post-Intervention (from Month 6 up to Month 36)

Change from Baseline in Number of Hospitalizations

Timeframe: Pre-Intervention (from Baseline up to Month 30), Post-Intervention (from Month 6 up to Month 36)