The synthetic opioid methadone, developed in Germany in the 1930s for the treatment of severe pain, has been employed for the Medication Assisted Treatment (MAT) of heroin addiction and opioid use disorder since the 1960s. In the US, methadone clinics are tightly regulated by the Drug Enforcement Administration and the Substance Abuse and Mental Health Services Administration.
Patients receiving methadone to treat their addiction must ingest it under the observation and supervision of clinic staff, who keep it in a lock box. Eventually, patients are permitted to take a few doses home with them for use over the weekend, and only after a lengthy course are some patients allowed to take home doses for themselves for “maintenance” purposes.
Individual states add additional layers of regulation. West Virginia has had a statewide moratorium on new methadone clinics since 2007. Georgia, Indiana, Louisiana, Mississippi, and Wyoming have onerous restrictions and caps on their growth. Ohio recently lifted its moratorium on privately-owned methadone clinics.
All of this makes it very difficult for health care practitioners who wish to treat patients with substance abuse disorder to do so using methadone. Despite these obstacles, the DEA reports it approved 254 new methadone clinics between 2014 and 2018 in response to the opioid overdose crisis. But the demand for methadone clinics far exceeds the supply. And it is unrealistic to expect people seeking treatment who live in rural areas or in states where methadone clinics are few and far between to drive long distances to and from the nearest clinic to take their daily dose.
Contrast this with MAT using buprenorphine (Suboxone). This partial opioid agonist was approved by the Food and Drug Administration for MAT in 2002 and was combined with the overdose antidote naloxone into its abuse-deterrent formulation, Suboxone, in 2010. Under the Drug Addiction and Treatment Act (DATA) passed in 2000, doctors were permitted to prescribe buprenorphine on an ambulatory basis after taking an 8-hour course and meeting other requirements administered by SAMHSA. There are strict limits on the number of patients a practitioner may treat, and nurse practitioners and physician assistants need to obtain a waiver in order to prescribe Suboxone. Congress passed the SUPPORT for Patients and Communities Act last October, raising the quota on the number of patients a doctor can treat while expanding the role of nurse practitioners and physician assistants. These regulations still deter many practitioners from providing MAT to their patients. SAMHSA reports that as of this date only 8 percent of practitioners have sought certification for buprenorphine treatment. Yet as onerous as these regulations may be, they are not nearly as onerous as those that govern methadone treatment.
As I have pointed out here, methadone has been prescribed for MAT in an office-based setting by primary care providers interested in treating substance abuse disorder for nearly 50 years in the UK, Canada, and Australia, with great success. A study of Scotland’s success with an office-based program was reported in JAMA back in 2000. That same year a review of the UK’s success with “oral methadone in a GP-centered programme” was reported in the journal Addiction. A 2003 study in the Journal of Substance Abuse and Treatment also had laudatory findings. In 2017 Eibl, et al provided an excellent review of Canada’s experience with office-based MAT.
In the US, government-approved trials using office-based methadone treatment by primary care practitioners by researchers at the University of Washington School of Medicine and Boston University School of Medicine had positive outcomes, and argued for revising the regulations on methadone treatment to more closely resemble those for buprenorphine.
Such a revision would go a long way towards increasing access to Medication Assisted Treatment—a purported goal of virtually everyone concerned about the overdose crisis. It might also induce states to redesign their methadone clinic regulations to more closely resemble those that currently apply to buprenorphine.
Meanwhile, a very helpful incremental reform would be to permit primary care practitioners in rural and other areas underserved by methadone clinics to obtain waivers from SAMHSA and the DEA so they can provide methadone MAT to their patients in a manner that mirrors current policy governing buprenorphine MAT. Such a nationwide pilot program might lead to an overhaul of America’s outdated and archaic approach to methadone MAT while providing needed help to those who seek it in rural and other underserved areas.