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
Ended Project Grant Awarded Last action
- Award ID
- R61DA057683
- Recipient
-
New York University UEI M5SZJ6VHUHN8 Part of New York University
- Awarding agency
-
National Institute on Drug Abuse
National Institutes of Health, Department of Health and Human Services
- Obligated
- $1,015,632
Award facts
- Assistance listing
- 93.279 Drug Use and Addiction Research Programs
- Completion date
- Place of performance
- New York, NY 10016, USA
Award details come from USAspending.gov.
Description
- Abstract
- 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. We propose a two-phased 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 phase 1 (R61), we 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 phase 2 (R33), we 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. We will specifically examine the effects of the intervention for black/african american and latinx clients.
Transactions
| Action | Obligated | Date |
|---|---|---|
| Amendment | -$181,958 | |
| Amendment | $0 | |
| Amendment | $0 | |
| Amendment | $598,795 | |
| Original award | $598,795 |
Subawards
| Subrecipient | Amount | Awarded |
|---|---|---|
| University Of Connecticut Health Center | $101,019 | |
| Weill Medical College Of Cornell University | $821,840 | |
| Weill Medical College Of Cornell University | $810,745 | |
| Research Foundation For Mental Hygiene, Inc. | $473,730 | |
| University Of Connecticut Health Center | $99,354 | |
| Research Foundation For Mental Hygiene, Inc. | $232,187 | |
| University Of Connecticut Health Center | $33,427 | |
| Weill Medical College Of Cornell University | $159,995 | |
| Research Foundation For Mental Hygiene, Inc. | $205,197 | |
| University Of Connecticut Health Center | $46,007 | |
| Weill Medical College Of Cornell University | $154,947 | |
| New York University | $58,891 |
Show all 12
Quick answers
Who received award R61DA057683?
R61DA057683 was awarded to New York University by National Institute on Drug Abuse (National Institutes of Health) on September 30, 2022.
How much is award R61DA057683 worth?
$1,015,632 has been obligated on R61DA057683.
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