Today, a majority of the methadone clinics are operated by for-profit corporations and comprise one of the most lucrative businesses in the field of drug treatment. Any attempt to change this model has been opposed by the clinics. As a result, the treatment of opioid addiction remains firmly separate from “normal” medical practice, which generally pursues more convenient options for patients, like being seen in a medical office.
COVID-19 and the requirement for social distancing prompted the federal Substance Abuse and Mental Health Services Administration (SAMHSA) to temporarily relax the rigid requirements of patients standing in line outside methadone clinics for their daily dose. SAMHSA has allowed methadone clinics to give patients 15–30 days of methadone to take at home. These relaxed rules should continue after the pandemic ends. The treatment of opioid addiction should be reintegrated into mainstream medical practice.
History: Methadone was originally developed in Germany during World War II as a synthetic opioid to alleviate an acute shortage of morphine. Methadone is relatively long-acting, with an effective half-life of 24 hours compared to about four hours for the opioid heroin. Methadone thus can be used to treat addiction to other opioids by helping addicts to detoxify or at least transition away from more dangerous drugs. Under a 1974 presidential order, methadone came into use as a treatment for patients addicted to heroin, including soldiers who became addicted to heroin while fighting the Vietnam War. The methadone clinic model was also codified in 1974 with the passage of the Narcotic Addict Treatment Act, which requires patients to receive methadone on a daily basis in a strictly regulated setting.
An alternative: Many opioids — including methadone — cause dose-related respiratory depression that can result in death at high doses. Buprenorphine, an opioid developed in the 1970s as a potent analgesic for post-operative pain, is characterized by a “ceiling” effect on respiratory depression: as the dose increases, respiratory depression plateaus. Buprenorphine users thus are unlikely to die of respiratory arrest or cessation. Yet, like methadone, buprenorphine can alleviate craving for more dangerous opioids. The safety of buprenorphine is conducive to using the medication in normal medical practices.
If buprenorphine can be prescribed by a physician in an office-based setting without restrictions, why do methadone clinics continue to dominate the field of opioid treatment? The answer is that regulatory barriers have been erected to protect the lucrative methadone clinic model.
To maintain the viability of methadone clinics while introducing a new office-based treatment modality using buprenorphine, policymakers reached a compromise whereby physicians have to take an eight-hour course on buprenorphine and then apply for Drug Enforcement Administration permission to prescribe the drug. Further, physicians are only permitted to have 30 patients in treatment in their first year of prescribing the drug, and then 275 (recently raised from 100) in subsequent years. In 2018, the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act did expand the prescribing authority for buprenorphine to physician assistants and nurse practitioners. Nonetheless, the tight restrictions on buprenorphine have had their intended effect of protecting the methadone clinics. As a result, less than 4% of physicians have obtained the DEA waiver and even fewer prescribe buprenorphine on a regular basis.
The pandemic: The national opioid emergency in 2017–2018 did not dramatically change the methadone-clinic-dominated status quo. But the current pandemic has. SAMHSA permits patients to take home a two- to four-week supply of methadone doses and facilitates the utilization of buprenorphine by suspending the requirement that the physician see the patient face-to-face before prescribing the drug for the first time.
Policymakers, treatment providers, patient advocates, patients, and — most critically — methadone clinics are closely watching this unprecedented relaxation of the rigid policies. What will patients do with the take-home doses? Will there be more overdose deaths, children accidently ingesting the drug, and diversion of the drug to others? If problems arise, the methadone clinics will lobby for reinstating the daily-clinic-visit model. On the other hand, if the experiment is reasonably successful, the clinic model that has been in place for over 50 years may not return.
Conclusion: The coronavirus pandemic has reduced the separation between the treatment of opioid addiction and normal medical practice. The temporary measures allowed by SAMSHA should be made permanent. This would require the repeal of the Ryan Haight Act requiring initial in-person doctor consultation before the prescribing of buprenorphine. In addition, methadone clinics, which by law can only provide that type of addiction service, should be allowed to operate like urgent care facilities and offer patients a range of services for all addictive disorders rather than just dispense methadone.