Problems Related to Social EnvironmentNCT05675735
Leveraging Regulatory Flexibility for Methadone Take-Home Dosing to Improve Retention in Treatment for Opioid Use Disorder
A study testing Clinic-Level Multidimensional Intervention in people with Problems Related to Social Environment, run by NYU Langone Health at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Problems Related to Social Environment
- What is being tested?
- Clinic-Level Multidimensional Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 4 sitesUnited States
- Study dates
- 27 Jan 2023to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
University at Buffalo
Buffalo, New York, 14260
- Recruiting
NYU Langone Health
New York, New York, 10016
Charles Neighbors, PhD
- Recruiting
Weill Cornell Medical College
New York, New York, 10065
Yuhua Bao
- Recruiting
University of Connecticut
Storrs, Connecticut, 06268
Megan O'Grady, Ph.D.
About this study
Official title: 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
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.
Read the detailed description
Regulatory changes made during the COVID-19 public health emergency (PHE) that relaxed criteria for take- home dosing (THD) of methadone offer an opportunity to improve retention in care with a lifesaving treatment. Methadone is a highly effective medication for treating opioid use disorders (OUD) that is provided in opioid treatment programs (OTPs). Yet, longstanding regulatory restrictions limit the availability of methadone as well as create demands that heavily burden clients by requiring frequent visits to clinics. The rationale for these regulations is to safeguard against diversion and overdoses from methadone. Yet, the history and application of methadone regulations stem from stigmatized and racist notions of people with OUD. Most OTPs are located within communities with predominantly Black/African American or Latinx populations. Consequently, Black/African American and Latinx individuals have greater access to methadone than other, less restricted, medications for OUD. Within OTPs, Black/African American and Latinx individuals are less likely to receive adequate dosing levels of methadone and have lower retention than non-Hispanic White clients. More flexible THD may help address disparities in care. Currently, there is a national debate about balancing safety concerns over more flexible THD against the benefits of client retention and quality of life. Low offering of THD in many OTPs suggests a need for new data-driven interventions to encourage changes in engrained clinical workflows and long-standing stigmatizing beliefs about OUD clients. OTP leadership and staff express concern about misapplying regulatory flexibility, of iatrogenic effects of greater THD, and about legal liability from overdoses or diversion. Finally, financial concerns mount for organizations that have long based their business models on billing for frequent in-person medication dispensing. This project stems from a well-established academic-public partnership in New York State between the Office of Addiction Services and Supports (OASAS) and research collaborators from New York University, Cornell University, and the University of Connecticut. The investigators propose a two-part project to develop then test a multidimensional OTP intervention to address clinical decision making, regulatory confusion, legal liability concerns, capacity for clinical practice change, and financial barriers to THD. The intervention will include OTP THD specific dashboards drawn from multiple State databases. The approach will be informed by the Health Equity Implementation Framework. In year 1, the investigators will employ an explanatory sequential mixed method design to combine analysis of large state administrative databases-Medicaid, treatment registry, THD reporting-with qualitative interviews to refine the intervention. In years 2-5, the investigators will conduct a stepped-wedge trial with 36 OTPs (~10,800 Medicaid clients/yr) randomized to 6 cohorts of a six-month long clinic-level intervention over three years. The trial will test the effects of the intervention on 1) THD; 2) retention in care; and 3) adverse healthcare events. The investigators will specifically examine the effects of the intervention for Black/African American and Latinx clients.
- Conditions
- Problems Related to Social Environment
- Being tested
- Clinic-Level Multidimensional Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinic-Level Multidimensional InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 6 of the 36 recruited opioid treatment programs (OTPs) will be enrolled in group 1. Group 1 will start the six-month intervention at Baseline and end at Month 6. Receives: Behavioral: Clinic-Level Multidimensional Intervention |
| Cohort 2 | Experimental | 6 of the 36 recruited opioid treatment programs (OTPs) will be enrolled in Cohort 2. Cohort 2 will start the six-month intervention at Month 6 and end at Month 12. Receives: Behavioral: Clinic-Level Multidimensional Intervention |
| Cohort 3 | Experimental | 6 of the 36 recruited opioid treatment programs (OTPs) will be enrolled in Cohort 3. Cohort 3 will start the six-month intervention at Month 12 and end at Month 18. Receives: Behavioral: Clinic-Level Multidimensional Intervention |
| Cohort 4 | Experimental | 6 of the 36 recruited opioid treatment programs (OTPs) will be enrolled in Cohort 4. Cohort 4 will start the six-month intervention at Month 18 and end at Month 24. Receives: Behavioral: Clinic-Level Multidimensional Intervention |
| Cohort 5 | Experimental | 6 of the 36 recruited opioid treatment programs (OTPs) will be enrolled in Cohort 5. Cohort 5 will start the six-month intervention at Month 24 and end at Month 30. Receives: Behavioral: Clinic-Level Multidimensional Intervention |
| Cohort 6 | Experimental | 6 of the 36 recruited opioid treatment programs (OTPs) will be enrolled in Cohort 5. Cohort 5 will start the six-month intervention at Month 30 and end at Month 36. Receives: Behavioral: Clinic-Level Multidimensional Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in 7-Day THD Prescriptions
7-day THD is defined as a prescription to pick up doses of methadone every 7 days or less often.
Measured: 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
14-day THD is defined as a prescription to pick up doses of methadone every 14 days or less often.
Measured: 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
28-day THD is defined as a prescription to pick up doses of methadone every 28 days or less often.
Measured: Pre-Intervention (from Baseline up to Month 30), Post-Intervention (from Month 6 up to Month 36)
Change from Baseline in OTP Care Retention
Will be calculated only among patients who have been in treatment for less than 12 months at the start of the study.
Measured: 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
Measured: Pre-Intervention (from Baseline up to Month 30), Post-Intervention (from Month 6 up to Month 36)
Change from Baseline in Number of Hospitalizations
Measured: Pre-Intervention (from Baseline up to Month 30), Post-Intervention (from Month 6 up to Month 36)
Change from Baseline in All-Cause Mortality
All-Cause Mortality defined as death due to any cause.
Measured: Pre-Intervention (from Baseline up to Month 30), Post-Intervention (from Month 6 up to Month 36)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start27 Jan 2023
- Primary completion1 Sep 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Problems Related to Social EnvironmentStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 318 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Charles Neighbors, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675735
- Sponsor's protocol ID
- 22-00892
- Status last verified
- Aug 2026
- First submitted
- 29 Dec 2022
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Aggregate data will be reported to protect privacy of participants. Data will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Charles.Neighbors@nyulangone.The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05675735
- Acronym / sponsor ID
- 22-00892
- Conditions
- Problems Related to Social Environment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 318 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 27 Jan 2023 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 9 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Regulatory changes made during the COVID-19 public health emergency (PHE) that relaxed criteria for take- home dosing (THD) of methadone offer an opportunity to improve retention in care with a lifesaving treatment. Methadone is a highly effective medication for treating opioid use disorders (OUD) that is provided in opioid treatment programs (OTPs). Yet, longstanding regulatory restrictions limit the availability of methadone as well as create demands that heavily burden clients by requiring frequent visits to clinics. The rationale for these regulations is to safeguard against diversion and overdoses from methadone. Yet, the history and application of methadone regulations stem from stigmatized and racist notions of people with OUD. Most OTPs are located within communities with predominantly Black/African American or Latinx populations. Consequently, Black/African American and Latinx individuals have greater access to methadone than other, less restricted, medications for OUD. Within OTPs, Black/African American and Latinx individuals are less likely to receive adequate dosing levels of methadone and have lower retention than non-Hispanic White clients. More flexible THD may help address disparities in care. Currently, there is a national debate about balancing safety concerns over more flexible THD against the benefits of client retention and quality of life. Low offering of THD in many OTPs suggests a need for new data-driven interventions to encourage changes in engrained clinical workflows and long-standing stigmatizing beliefs about OUD clients. OTP leadership and staff express concern about misapplying regulatory flexibility, of iatrogenic effects of greater THD, and about legal liability from overdoses or diversion. Finally, financial concerns mount for organizations that have long based their business models on billing for frequent in-person medication dispensing. This project stems from a well-established academic-public partnership in New York State between the Office of Addiction Services and Supports (OASAS) and research collaborators from New York University, Cornell University, and the University of Connecticut. The investigators propose a two-part project to develop then test a multidimensional OTP intervention to address clinical decision making, regulatory confusion, legal liability concerns, capacity for clinical practice change, and financial barriers to THD. The intervention will include OTP THD specific dashboards drawn from multiple State databases. The approach will be informed by the Health Equity Implementation Framework. In year 1, the investigators will employ an explanatory sequential mixed method design to combine analysis of large state administrative databases-Medicaid, treatment registry, THD reporting-with qualitative interviews to refine the intervention. In years 2-5, the investigators will conduct a stepped-wedge trial with 36 OTPs (~10,800 Medicaid clients/yr) randomized to 6 cohorts of a six-month long clinic-level intervention over three years. The trial will test the effects of the intervention on 1) THD; 2) retention in care; and 3) adverse healthcare events. The investigators will specifically examine the effects of the intervention for Black/African American and Latinx clients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Behavioral: Clinic-Level Multidimensional Intervention6 of the 36 recruited opioid treatment programs (OTPs) will be enrolled in group 1. Group 1 will start the six-month intervention at Baseline and end at Month 6. |
| Cohort 2 | Experimental | Behavioral: Clinic-Level Multidimensional Intervention6 of the 36 recruited opioid treatment programs (OTPs) will be enrolled in Cohort 2. Cohort 2 will start the six-month intervention at Month 6 and end at Month 12. |
| Cohort 3 | Experimental | Behavioral: Clinic-Level Multidimensional Intervention6 of the 36 recruited opioid treatment programs (OTPs) will be enrolled in Cohort 3. Cohort 3 will start the six-month intervention at Month 12 and end at Month 18. |
| Cohort 4 | Experimental | Behavioral: Clinic-Level Multidimensional Intervention6 of the 36 recruited opioid treatment programs (OTPs) will be enrolled in Cohort 4. Cohort 4 will start the six-month intervention at Month 18 and end at Month 24. |
| Cohort 5 | Experimental | Behavioral: Clinic-Level Multidimensional Intervention6 of the 36 recruited opioid treatment programs (OTPs) will be enrolled in Cohort 5. Cohort 5 will start the six-month intervention at Month 24 and end at Month 30. |
| Cohort 6 | Experimental | Behavioral: Clinic-Level Multidimensional Intervention6 of the 36 recruited opioid treatment programs (OTPs) will be enrolled in Cohort 5. Cohort 5 will start the six-month intervention at Month 30 and end at Month 36. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinic-Level Multidimensional InterventionThe 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. | Behavioural | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6 |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: Yes. Aggregate data will be reported to protect privacy of participants. Data will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Charles.Neighbors@nyulangone.The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charles Neighbors, PhD principal investigator
NYU Langone Health
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinic-Level Multidimensional Intervention in people with Problems Related to Social Environment, run by NYU Langone Health at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charles Neighbors, PhD (646-501-3875, Charles.Neighbors@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.