The task force was asked to develop a research agenda to expand and create more equitable access to methadone for OUD. 24 In response to COVID-19 disruptions, the rapid adaptation of US methadone treatment services, and the ongoing inequities in opioid agonist treatment access, the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) created the Methadone Access Research Task Force. 21– 23 These COVID-19–related changes to the regulations governing methadone treatment have created opportunities to revisit the traditional ways of conducting methadone treatment and inspired thinking about alternative models for delivery of methadone. 18– 20 To mitigate the risk, the US Substance Abuse and Mental Health Services Administration (SAMHSA) and the Drug Enforcement Administration (DEA) relaxed restrictions on dispensing of methadone take-home dosing and allowed for the use of telemedicine for established patients receiving methadone. 15– 17 The crowding of patients within OTPs required rapid changes in the delivery system to reduce the risk of transmission of the virus that causes COVID-19. The COVID-19 pandemic and its associated social distancing and lockdown measures have created unprecedented challenges for the treatment of OUD. Despite the increased number of OTPs in recent years due to expansion of the for-profit sector, 5 there remains a shortage of methadone treatment that contributes to racial, gender, and geographic inequities in access to such treatment in the US. DATA 2000 did not address the provision of methadone treatment outside of federally and state-regulated opioid treatment programs (OTPs) and did not increase access of methadone treatment within OTPs. 4 The Drug Addiction Treatment Act of 2000 (DATA 2000) expanded access to medication-based treatment within the US by creating a pathway for medication treatment in office-based settings to date, formulations of buprenorphine (a partial agonist opioid) are the only approved medications for OUD (MOUD) treatment under DATA 2000. 2 US methadone treatment capacity has not expanded proportionately with rising opioid overdose deaths, 3 and not all patients who may benefit from methadone, a full agonist opioid medication, are able to access this treatment. 1 Methadone treatment for opioid use disorder (OUD) is effective in reducing opioid morbidity and mortality, with more than 50 years of evidence. In the US, opioid overdose deaths are rising in the context of fentanyl use and the coronavirus 2019 (COVID-19) pandemic. Together, the research priorities and cross-cutting issues represent a compelling research agenda to expand access to methadone in the US. In addition to outlining these research priorities, the task force identified important cross-cutting issues, including the impact of patient characteristics, treatment, and treatment system characteristics such as methadone formulation and dose, concurrent behavioral treatment, frequency of dispensing, urine or oral fluid testing, and methods of measuring clinical outcomes. The task force identified 6 areas where research is needed: (1) access to methadone in general medical and other outpatient settings (2) the impact of methadone treatment setting on patient outcomes (3) impact of treatment structure on outcomes in patients receiving methadone (4) comparative effectiveness of different medications to treat OUD (5) optimal educational and support structure for provision of methadone by medical providers and (6) benefits and harms of expanded methadone access. This research agenda included mechanisms that are available within and outside the current regulations. The National Institute on Drug Abuse Clinical Trials Network convened the Methadone Access Research Task Force to develop a research agenda to expand and create more equitable access to methadone treatment for OUD. There is a shortage of OTPs, and racial and geographic inequities exist in access to methadone treatment. In the US, methadone treatment can only be provided to patients with opioid use disorder (OUD) through federal and state-regulated opioid treatment programs (OTPs).
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