FAQ

Methadone is a long-acting full opioid agonist and a schedule II controlled substance medication, used to treat opioid use disorder (OUD) and pain. It is considered a gold standard treatment by the National Institutes of Health and an essential medication by the World Health Organization. These designations recognize methadone as a safe and effective, cost-effective medication that provides a robust public health benefit. Taken daily, methadone for OUD works by reducing opioid craving and withdrawal symptoms. Methadone also reduces the adverse effects of illicit opioid misuse, including overdose risk. Currently, in the United States, methadone for OUD is primarily dispensed through federally certified and state licensed opioid treatment programs (OTP).

The majority of individuals receiving methadone treatment for OUD in the United States receive methadone via an opioid treatment program (OTP). An OTP is a federally-certified (SAMHSA) and state licensed facility for the treatment of OUD . OTPs administer and dispense methadone and, under federal law 42 CFR 8.12, must offer counseling as well as medical, educational, vocational, and other services. Initially, many patients receive their methadone doses daily, in-person, at their OTP. Patients may be eligible to receive several doses during a clinic visit, to take at home, known as “take-home” doses, without medical supervision. The number of “take-home” doses a patient is eligible for and when they become eligible for them (whether immediately upon starting treatment or after a period of time) may vary by treatment facility and is often though not always determined by the OTP based on clinical stability of the patient and the patient’s needs and preferences. Clinical stability is typically assessed by some combination of regular attendance at the OTP, medication adherence, engagement with other services such as counseling, and reduction in or abstinence from illicit drug use. In a limited number of cases for stable patients, methadone for OUD is also provided in office-based outpatient settings if the prescribing physician’s office is affiliated with an OTP.

Further information about how methadone works pharmacologically to treat OUD may be found online at SAMHSA.gov.

SAMHSA’s final rule on methadone (42 CFR Part 8), issued in 2024, introduced several notable changes to methadone treatment policy affecting take-home dosing, telehealth, accreditation processes, treatment standards, scope of practice, and more. SAMHSA has published a summary table outlining all changes on their website. Implementation of SAMHSA’s final rule varies across states and OTP facilities [1].

Methadone is a highly effective treatment for OUD, and particularly relevant in the context of the fentanyl-driven overdose crisis.

Methadone decreases drug use, overdose mortality, HIV transmission, criminal activity, and all-cause mortality [2]. It is considered a gold standard treatment by the National Institutes of Health and an essential medication by the World Health Organization. Regulators, patients, and clinicians report an increased need for methadone in treating OUD in response to the fentanyl crisis. There is an urgent need to identify effective strategies to increase access to and quality of methadone treatment in the United States.

As with many components of healthcare, the current methadone treatment system has limits in terms of access, quality, and patient experience.

With over 2,000 OTPs operating in the U.S. as of 2024, challenges to treatment access, quality, and experience persist. While many patients reflect positively on their treatment experience at OTPs, others describe their experience as inflexible, overly surveilled, and stigmatizing. Methadone treatment policies and practices vary across states and individual OTPs, with some facilities offering low-barrier access and others imposing stricter requirements and expectations. In April 2024, SAMHSA issued its new 42 CFR Part A final rule on methadone, standardizing some of flexibilities introduced to methadone treatment during the COVID-19 pandemic. Some OTPs have moved to implement these latest federal regulations, and others have been more selective. Several other promising models of methadone treatment have potential to expand methadone access and enhance patient experience and choice. These include OTP- and office-based prescribing with pharmacy dispensing, fixed medication site dispensing, mobile dispensing, and “medical maintenance” wherein patients are transferred from OTPs to office-based practices on the basis of clinical stability while retaining access to expanded OTP services. There is also potential for innovations to expand access to methadone beyond the OTP system in carceral settings, skilled nursing facilities, hospitals, and emergency departments. Many of these models are already in use internationally and warrant further consideration by the United States.

Multiple entities have strong, sometimes conflicting views on how to improve methadone access and quality.

Rising attention to the overdose crisis, enacted and proposed changes in methadone regulation and clinical practice, interest from patients, providers, and public health advocates, and burgeoning support for expansion of methadone treatment from entities such as the National Academies of Sciences, Engineering, and Medicine and National Institutes of Health, have compelled various stakeholders to express their views on how improvements to methadone quality and access can or should occur. Alternative and sometimes competing visions exist across federal and state regulatory authorities and legislators, OTP leadership and their organizational representation, patient organizations, addiction medicine and psychiatry clinicians, professional societies, trade organizations, and public health researchers. See the Resources page to view these materials.

There is a unique opportunity for an external entity serving as a neutral convener to provide guidance on projects and policies that can inform systemic changes towards improving access and quality.

Given the complexities of our current methadone treatment system and the range of viewpoints informing how this system can improve quality and access, a “big picture” longitudinal effort to identify effective processes for engaging a diverse and broad range of stakeholders is needed. The NMAQC will identify needs and opportunities to advance methadone access and quality in the US within and beyond the OTP system.

The National Commission on Methadone Access and Quality (NMAQC) is made possible by a three-year establishing grant from the Foundation for Opioid Response Efforts (FORE). Media inquiries for FORE may be directed to Myrna Manners at Manners Public Relations (718-986-7255 or mmanners@mannerspr.com).

[1] Sherrick R, Tamar H, Schaefer M. Implementing SAMHSA’s Final Rule: Challenges and Outcomes for Opioid Treatment Programs. American Society of Addiction Medicine (ASAM) eLearning. 2025 Apr 25.

[2] Substance Abuse and Mental Health Services Administration. Medications for Opioid Use Disorder. Treatment Improvement Protocol (TIP) Series 63 Publication No. PEP21-02-01-002. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2021.