NCT05675735 · NYU Langone Health
Leveraging Regulatory Flexibility for Methadone Take-Home Dosing to Improve Retention in Treatment for Opioid Use Disorder
What this study is about
Using a stepped-wedge randomly assigned 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.
View original scientific description
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.
Interventions
BEHAVIORAL
Clinic-Level Multidimensional Intervention
The proximal goal of the intervention will be to increase OTP uptake of flexible THD. The intervention addresses facilitators and barriers to THD practices as identified by existing studies as well as those found during the first phase of the current project. The intervention will be designed to address the information gaps, training needs, and beliefs of individuals across the organizations.
Primary outcome measures
Change from Baseline in 7-Day THD Prescriptions
Time frame: Pre-Intervention (from Baseline up to Month 30), Post-Intervention (from Month 6 up to Month 36)
7-day THD is defined as a prescription to pick up doses of methadone every 7 days or less often.
Change from Baseline in 14-Day THD Prescriptions
Time frame: Pre-Intervention (from Baseline up to Month 30), Post-Intervention (from Month 6 up to Month 36)
14-day THD is defined as a prescription to pick up doses of methadone every 14 days or less often.
Change from Baseline in 28-Day THD Prescriptions
Time frame: Pre-Intervention (from Baseline up to Month 30), Post-Intervention (from Month 6 up to Month 36)
28-day THD is defined as a prescription to pick up doses of methadone every 28 days or less often.
Change from Baseline in OTP Care Retention
Time frame: Pre-Intervention (from Baseline up to Month 30), Post-Intervention (from Month 6 up to Month 36)
Will be calculated only among patients who have been in treatment for less than 12 months at the start of the study.
Change from Baseline in Number of Emergency Department Visits
Time frame: Pre-Intervention (from Baseline up to Month 30), Post-Intervention (from Month 6 up to Month 36)
Change from Baseline in Number of Hospitalizations
Time frame: Pre-Intervention (from Baseline up to Month 30), Post-Intervention (from Month 6 up to Month 36)
Change from Baseline in All-Cause Mortality
Time frame: Pre-Intervention (from Baseline up to Month 30), Post-Intervention (from Month 6 up to Month 36)
All-Cause Mortality defined as death due to any cause.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Storrs, Connecticut
- Buffalo, New York
- New York, New York
Collaborators
National Institutes of Health (NIH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 12, 2026 · Source of record for eligibility and locations