Since the Food and Drug Administration approved methadone for treating opioid use disorder in 1972, its distribution has been strictly regulated. The regulations were put in place to ensure public and patient safety. But they made it hard for people to get the treatment they need.
Until recently, most people had to visit a methadone clinic in person for an initial exam and then come in five to six days a week to take their doses under the watchful eye of a health care professional. One of the ideas behind this was to prevent people from diverting methadone to share with friends or sell on the street. The reality of it for patients was the requirement to visit an opioid treatment program nearly every day, which could significantly interfere with work and family obligations like child care. Transportation was also a problem for many.
When Covid-19 began sweeping through the U.S. in March 2020, the federal Substance Abuse and Mental Health Services Administration (SAMHSA) changed its policies to reduce the risk of the coronavirus being spread at opioid treatment programs. If state governments agreed, these programs could give individuals who were stable in their treatment up to 28 days of take-home methadone doses, and 14 days to those who were less stable. This was a momentous change, offering people and clinics more flexibility during the difficult times of the pandemic.
In February 2024, SAMHSA issued a final rule making the policy change permanent.
Despite the widespread appreciation for take-home privileges by both patients and practitioners, a troubling trend has emerged. States and local OTPs have broad discretion over their treatment programs, consistent with SAMHSA regulations. Six states — Arizona, Florida, Indiana, Ohio, Michigan, and Mississippi — and a growing number of OTPs throughout the country have rescinded their policy of extended take-home privileges. The exact details are hard to come by, even with Freedom of Information Act requests.
Critics of the SAMHSA take-home policy have argued that it leads to methadone misuse and diversion. That’s contrary to a growing body of evidence showing that increased flexibility in methadone delivery hasn’t increased methadone-related overdose deaths in the U.S., and that the policy flexibility does not threaten public health and safety. In fact, for groups such as Black and Latino men, the increase in take-home doses has led to fewer methadone-related deaths.
New evidence also suggests that the take-home policy has increased patient retention in treatment. Before the take-home policy change, the median retention rate in opioid treatment programs was approximately 57% at 12 months, falling to 38% at 36 months. A recent systematic review suggests that the take-home policy improved these desperately low retention rates.
Higher retention rates not only facilitate successful treatment, they also dramatically reduce the incidence of methadone-involved fatal overdoses. One reason is methadone’s unique pharmacological profile. It has a long half-life, which allows for a once-daily dosing to manage opioid dependence effectively. Depending on the individual, this also means that even small deviations from the regimen, such as missing two or three doses, can disrupt methadone’s balance in the body, causing excruciating withdrawal symptoms or overdose if other opioids are used. Withdrawal can also elevate the risks of job loss, infections from returning to drug use, depression, and incarceration.
The delicate balance maintained by methadone’s pharmacology underscores the problems with an approach to policymaking that assumes a regimen compliance with little margin for error.
Given the stringent policies that had surrounded methadone dispensing, the difficulties some people have getting to their opioid treatment program and the severe consequences of missing doses, it is not surprising that people in methadone treatment make informal arrangements to loosen the “liquid handcuffs.” Transferring or sharing methadone to individuals for whom it was not dispensed — often to help someone manage the terrible pain associated with opioid withdrawal — is called diversion. But probably because methadone doesn’t have the same psychotropic effects as other opioids, diverted methadone comprises only a tiny portion of the illicit drug market.
Practically, it is impossible to stop people from accumulating and sharing small quantities of medicines in the absence of a highly punitive and debasing set of restrictions. Effectively managing opioid treatment requires tolerating a minimal, controlled level of medication sharing, even though sharing is illegal. Addressing diversion as a reflection of unmet community need will be more effective in the long term than criminalizing it.
Cutting back or eliminating take-home methadone doses may push people enrolled in opioid treatment programs toward illicit drug use, making the overdose crisis worse. It may also heighten feelings of frustration and hopelessness among those in treatment, resulting in more relapses, greater health care costs, and lives lost.
The treatment of opioid use disorder took a step forward when rules for methadone dispensing were loosened. The country can’t afford to step backward to the old ways that don’t work.
Rebecca Arden Harris is an addiction medicine physician in the Department of Family Medicine and Community Health at the University of Pennsylvania. David S. Mandell is the Kenneth E. Appel Professor of Psychiatry and director of the Penn Center for Mental Health at the University of Pennsylvania.