Inflexible methadone regulations impede America’s efforts to reduce overdose deaths

Imagine if people who needed insulin to control their diabetes had to trek across town each day to receive this lifesaving drug at an insulin clinic — with no accommodations for work or family obligations — an approach justified because they can’t be trusted to administer insulin correctly and avoid life-threatening episodes of low-blood sugar.

Not in America you might say.

But such paternalism is a reality for hundreds of thousands of Americans using methadone to treat opioid addiction and live a healthy life. By law, they can get methadone only by attending a special — usually isolated — clinic which may interfere with other steps important for recovery, like childcare or employment.

We are members of a 17-person task force convened by the National Institute on Drug Abuse to develop a scientific agenda for expanding access to methadone treatment across the United States. Methadone is one of three medications approved to treat opioid addiction; the other two are buprenorphine and extended-release naltrexone. Decades of evidence support the effectiveness of methadone for reducing overdose deaths, infectious diseases, and advancing a broader recovery.

In the U.S., methadone treatment for opioid addiction is restricted to certified methadone clinics. Most suburban and rural communities, and even some smaller cities, lack such clinics. Federal and state regulations mandate how often methadone can be administered, the kind of counseling that should go along with it, and how recipients should be monitored for opioid use. Although this might appear constructive, there are reasons Americans do not tolerate such government intrusion for other diseases.

Inflexible methadone regulations lead to the segregation of opioid addiction treatment across communities and a shortage of clinics that administer it. The type of treatment Americans receive for opioid addiction is not purely driven by science or medical necessity, but is also influenced by race and geography. Black Americans are more likely than whites to be treated in methadone clinics, while white Americans are more likely to be treated with buprenorphine in more flexible and anonymous primary care clinics. In rural and suburban America, people with opioid use disorder who do not respond to other treatment, such as buprenorphine, often live too far away from methadone clinics. These inequalities were further stressed by Covid-19.

Our task force reviewed the science, regulations, and impact of Covid-19 on methadone treatment internationally and identified six scientific priorities to address these problems and let patient needs — rather than federal and state regulations — determine treatment. There are important unsettled questions, such as how to match patients to the best treatment, and the optimal frequency of observed methadone ingestion. Because many of these research priorities include steps beyond what is currently permissible under federal and state regulations, the ability of the scientific and public health communities to pursue these approaches is effectively prohibited.

One example is eligibility for take-home methadone. Federal and state regulations determine how long people must be in treatment before they can get methadone to be taken at home. During the first 90 days of treatment, an individual must go to the clinic and be observed taking the medication a minimum of six days a week. Those who meet specific requirements can get gradually increased amounts of take-home methadone. But it is not until one year of treatment that individuals are eligible for even two weeks of take-home medication.

Regulators wisely relaxed these requirements during Covid-19 to reduce travel and facilitate social distancing. They allowed up to 28 days of take-home medication for people who were stable and up to 14 days for those who were less stable. As the permanence of these changes is now being considered in Congress, it’s worth a reminder that, for virtually every other disease, such decisions are left to health providers and patients. Even if scholars work through the regulatory red tape and discover a more effective take-home schedule, health providers and patients would be prohibited from adopting it without legislative action.

Other countries show what is possible. In response to the overdose epidemic, Canada created flexible methadone regulations. The federal government handed regulation to the provinces, treatment can occur within specialty or primary care clinics, and pharmacies can administer methadone. This flexibility expanded services and allowed integration of opioid addiction treatment into the rest of the health care system. While regulations do vary from province to province, Canadian health care providers have a greater say in the structure of treatment, allowing for a more adaptable treatment system.

To advance the scientific agenda of the task force and, more importantly, expand access to methadone treatment, federal and state legislatures in the U.S. must enact more flexible regulations empowering health providers and patients to act on emerging science about the treatment of opioid addiction. Methadone treatment should be allowed across a wide range of health care settings, including primary care clinics and pharmacies, and the treatment plan should be determined by science, providers, and patients. Because many U.S. communities lack access to specialty mental health providers, it is important that more-flexible regulations include an option for primary care methadone prescribing for addiction treatment.

There’s no question that methadone, like all opioids, can cause an overdose when taken outside of medical treatment, and some people may not benefit from less-monitored treatment. But science can address this challenge and others — if given the space to operate. As with other diseases, science and health provider autonomy can match patients to the type, location, and frequency of treatment most enabling of success. This would preserve highly structured treatment for those who need it while expanding treatment options for those who do not. More flexible regulations would also close racial and geographic disparities in access to treatment for opioid addiction.

The onerous regulations dictating how, where, and when methadone can be used to treat addiction stand in stark contrast to the light touch of regulations regarding prescribing methadone for pain. Clinicians are not required to do additional training or licensing to prescribe methadone for pain, and it is available in clinics and pharmacies across the U.S. Opioid prescribing for pain contributed to the epidemic of overdose deaths, yet no analogous federal and state regulations have been placed on prescribing these drugs for pain. More flexible methadone regulations for the treatment of addiction can be enacted while utilizing the less intrusive monitoring strategies for other opioids.

It’s estimated that more than 90,000 people died of drug overdoses in 2020. The scientific community is eager to generate further innovations. With flexible methadone regulations in the United States, scientists, health providers, and patients will be able to pursue these innovations and maximize health.

Paul J. Joudrey is a primary care physician and assistant professor at the Yale Program in Addiction Medicine. Adam J. Gordon is a primary care physician and professor of medicine and psychiatry at the University of Utah School of Medicine and chief of addiction medicine at the VA Salt Lake City Health Care System. Both are addiction medicine specialists, health services researchers, and co-authors of the National Institute on Drug Abuse Clinical Trials Network Task Force report on research priorities for expanding access to methadone treatment for opioid use disorder in the U.S. The views expressed here are solely the responsibility of the authors and do not necessarily represent the official views of the National Institute on Drug Abuse, the Department of Veterans Affairs, or their academic institutions.