Extended-release Opioid Use Disorder treatment in Massachusetts (EXOUD-Mass) - Project Summary In 2022, an estimated 9.4 million people needed treatment for OUD. Opioid-related overdose deaths (OODs), primarily due to fentanyl, reached nearly 85,000 for the 12-month period through June of 2023. OODs increased 4- fold since the year 2001 in Massachusetts (MA), with >2,000 OODs each year from 2016 to 2023. Medications for OUD (MOUD), including opioid agonists (methadone), partial agonists (buprenorphine), and antagonists (naltrexone) are effective in treating OUD, with buprenorphine and methadone associated with up to 59% reductions in OOD risk. Whereas many nations meet or exceed international benchmarks to provide MOUD to >50% of people with OUD, US MOUD coverage rates are 25% or less. To reduce US OODs, there is an urgent need to increase coverage and improve access and adherence to a full range of MOUD treatment modalities. In 2017, the FDA approved an extended-release- buprenorphine (XRB) formulation with subcutaneous injections of 100mg or 300mg administered monthly by a clinician. Another XRB weekly and monthly formulation was FDA-approved in 2023. XRB was non-inferior to transmucosal buprenorphine (TMB) among stable patients in the pre-fentanyl era in FDA approval trials. XRB formulations may improve MOUD treatment adherence, with early studies showing high treatment retention and reduced opioid use, and a high proportion of XRB patients remaining opioid abstinent. However, a nationally representative study of commercially insured patients showed 64% discontinuation rates at 3 months, similar to other MOUD. Our goal is to understand how XRB formulations can be best integrated into the menu of MOUD options accessible within treatment venues and among people living with OUD. To fill gaps in knowledge regarding XRB formulations, we will examine perceived XRB advantages and disadvantages, factors impacting MOUD treatment choices, and the geographic distribution of XRB treatment vs. other MOUD uptake. Guided by the Patient-Centered Healthcare Accessibility framework, this community-engaged, exploratory sequential, mixed methods study will: (1) Assess the intentions of patients who have initiated XRB vs. TMB and the barriers and facilitators they have faced via in-depth qualitative interviews (n=35-40) and a cross-sectional statewide survey of XRB patients (n=300); (2) identify the characteristics of patients initiating and continuing XRB vs. TMB in MA, including their MOUD treatment experience and demographics using the MA Public Health Data Warehouse, a population- level database of >35 individually-linked administrative data, providing a virtual census of the MA population, facilitating statistical and spatial epidemiological analyses to describe statewide XRB access, initiation, and continuation; (3) describe patient outcomes among those who continue and discontinue XRB, including the incidence of restarting XRB, switching to other MOUD, nonfatal and fatal overdose incidence, and all-cause mortality. Our multidisciplinary team has the requisite expertise in epidemiology, anthropology, biostatistics, addiction medicine, and health services research, and will be guided by our advisory board comprised of current XRB and former XRB patients, XRB providers, harm reduction, and public health experts. Our novel approach will help pave the way towards next steps in intervention development to expand XRB and other MOUD options, informing paradigm shifting OUD treatment approaches and a subsequent RCT.
