Unbeknownst to most clinicians, access to methadone remains shrouded in mystery, misunderstanding, and misinformation. However, I learned by working in a federally designated Opioid Treatment Program (OTP) where methadone is the primary intervention that it is a monumental issue.

In preparing a poster for the upcoming annual conference of the American Academy for the Treatment of Opioid Dependence, I learned about the history of restrictions on methadone for the treatment of addiction. Perhaps no other drug is as restricted for an approved use (opioid use disorder [OUD]), yet has few restrictions when it is used for pain management. Methadone is a schedule II medication, thus requiring a Drug Enforcement Agency (DEA) license to prescribe. These restrictions make little sense and reek of the stigma and discrimination faced by patients with OUD.

Methadone was introduced as a medication to treat OUD in the late 1960s. Some of the pioneers of this use were Drs Vincent Dole, Marie Nyswander, and Marie Jane Kreek. They published groundbreaking work at Rockefeller University. In an interview with Dr Dole from the winter issue of Addiction Treatment Forum, Dr Dole described his surprise and deep disappointment in the cool reception to methadone from the medical community in the 60s:

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From the beginning of our research with methadone we were able to rehabilitate otherwise hopeless addicts that had been through all of the other treatments available. I expected methadone would be taken up very carefully by the addiction treatment community, but with some enthusiasm. Instead of that, we’ve had endless moral and other types of objections which are really irrelevant to the scientific data.

I was surprised, because my background in research had led me to expect that the medical community was a very critical but nonetheless objective group that would respond to solid, reproducible data. Instead I find that we still get the anti-methadone argument of substituting one addictive drug for another.

This is ignoring the scientific data showing that, as a result of methadone treatment, people who have been hopelessly addicted and anti-social and excluded from any normal life or family, are in a wonderful way becoming responsive to social rehabilitation and today constitute a very large number of people who are living normal lives. The fact that people, especially medical practitioners, would dismiss that as unimportant simply staggers me!

When asked a follow-up question about whether he saw attitudes changing about methadone, his disturbing response was “Yes, especially outside of the United States.” In subsequent years, surprisingly little has changed with the restrictions in the US. No provider, including physicians, PAs, nurse practitioners, or pharmacists, can legally prescribe methadone for the treatment of addiction: period, end of story. Methadone can only be dispensed in heavily regulated Opioid Treatment Programs (OTPs) and hospital inpatients. Moving to take-home doses remains arduous.

Yet, the silver lining is that the restrictions and quarantine necessitated by the COVID-19 pandemic restrictions were accompanied by significant breakthroughs in lifting methadone restrictions. With the pandemic came new and urgent visioning of how we could maintain treatment for OUD patients while looking for ways to decrease the spread of COVID. Many clinics, including mine, led the way in appealing to the Substance Abuse and Mental Health Services Administration (SAMHSA) to loosen take-home regulations to decrease crowding in clinics.

SAMHSA’s response was positive and heartening, although they were hardly in a position to toe the line and keep restrictions. The result was that patients were able to get more medication dispensed at one time so they could come to the clinic less frequently. Many feared this would lead to increased overdoses and diversion of take-home medication.

Data has shown otherwise. Findings presented at a recent workshop by the National Academies of Sciences, Engineering, and Medicine illustrate that methadone dose relaxations during the pandemic were associated with increased methadone take-home doses, improved retention, and decreased urine drug test (UDT)-positive results among clinically stable patients. Reduced take-home restrictions were found to be feasible and desirable without posing safety or public health harm.  

Other pathways to a responsible and medically-sound reduction of restrictions were discussed at the high-profile workshop. Future visioning took place with discussion about how to expand access and address restrictions that contribute to health disparities. This included actions such as expanding Medicaid coverage, expanding access to methadone beyond OTPs including via telehealth, making methadone accessible in primary care settings, and requiring Medicaid to pay for medication-assisted therapy (MAT) medications.  

Ultimately, it will take continued pressuring of SAMHSA, along with an increased openness on the part of regulators to the increasing data on the success of the lifting of methadone restrictions during the COVID-19 pandemic. One of the most workable ways to do this would be for SAMHSA to use its statutory authority to make current pandemic flexibilities permanent as well as look at other ways to safely increase access.

Only time will tell if the medical community is ready to lead such an effort, but it certainly appears to be a time of extreme opportunity.