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.