Ann Hui Ching, Senior Photographer

As of Oct. 2, clinics must comply with new reduced regulations for accessing methadone, a life-saving medication for treating opioid use disorder.

Prior to the updated federal regulations, methadone was regulated more extensively in the United States than any other therapeutic drug. Methadone is an effective medication that reduces symptoms of withdrawal, cravings and overdose. Of the three approved medications for the treatment of opioid use disorder— methadone, buprenorphine and naltrexone— methadone is the only full opioid agonist, meaning that it is more potent than its alternatives. 

“The more people that have access to methadone, the better,” Cara Borelli, an instructor at the School of Medicine who specializes in addiction medicine, told the News. “[These changes] are a step in the right direction.” 

According to Borelli, the previous restrictions for receiving methadone treatment negatively affected patients’ quality of life. These regulations involved very frequent dosing of methadone — for the first months of treatment, patients had to show up at their opioid treatment programs every single day to receive their medication before becoming eligible to receive take-home treatment.

In addition, methadone can only be dispensed from opioid treatment programs as opposed to buprenorphine and naltrexone, which can be picked up from pharmacies. 

“Having to go into clinic every single day is a huge barrier,” Borelli said. “People have jobs, people have education, people have mobility impairments. Some of my patients physically can’t get into clinic every day.”

During the pandemic, the Substance Abuse and Mental Health Association, which oversees regulations for medicating substance use disorders, created exemptions to reduce in-person interaction and exposure. The exemptions allowed stable patients to receive up to 28 days of take-home bottles at a time, a privilege previously reserved for patients who had been in treatment for an extended period of time.

Studies conducted over the course of the pandemic assessed the more flexible regulations and found that patients who received treatment via take-home doses were no more likely to overdose or drop out of care than those who had to pick up medication daily.

The success of the relaxed regulations during the pandemic prompted the changes to be made permanent. The most significant of the changes allows patients to receive take-home doses starting from the first week of treatment under certain conditions. However, additional changes were made to remove unnecessary barriers to treatment. 

The new regulations also eliminate the requirement for one year of opioid addiction history, make treatment more accessible for patients who are pregnant or under 18 and allow for higher starting doses for individuals with high opioid tolerances — which has become increasingly common with the expanding use of fentanyl.

“There have been studies showing that having more flexibility increases retention,” Borelli said. “Continuing methadone treatment is associated with decreased mortality, so staying in treatment is really important.”

Methadone treatment has been associated with a 76 percent reduction in overdoses at three months, and with the increased flexibility provided by the updated regulations, more patients will be able to start and continue receiving treatment.

Allowing patients to receive take-home doses will reduce the strain of having to transit to an opioid treatment program daily, and will also reduce the length of lines for receiving treatment. In the past, these lines have been long enough to stretch out of the building, according to Kenneth Morford, who takes care of patients with substance use disorders at the Apt Foundation, the largest opioid treatment program in New Haven.

“I think it allows people to feel like they’re receiving a medication that’s a bit more similar to other medications,” Morford told the News. “I’ve seen a lot of the people that I take care of really enjoying that flexibility and feeling more like a human being, more respected.”

The deregulation of methadone is a step towards the destigmatization of receiving treatment for substance use disorders. David Fiellin, a professor at the School of Medicine, mentioned the common misconception that substance use medications like methadone are just “trading one addiction for another.” 

Fiellin described how methadone’s specific attributes — being non-reinforcing, taken orally and working for 24 hours — allow patients to regain control of their lives in a way that they cannot when still using. Methadone does not cause euphoria when appropriately dosed, eliminates the risk of infection caused by injection, and allows patients to go about their days without worrying about their next dose. 

Even with the reduced regulations, methadone is still more strictly regulated than many other medications.

“I’m a primary care physician with specialty training in addiction medicine,” Fiellin said. “And the recent changes in methadone oversight and regulation still do not allow for it to be prescribed by somebody like myself and dispensed in a community pharmacy.”

The new regulations still require methadone to be distributed from specialized opioid treatment programs, rather than prescribed by physicians and distributed at pharmacies. 

There are less than 2,000 opioid treatment programs in the United States, compared to over 60,000 pharmacies and almost one million physicians. For patients living in rural areas, the nearest Opioid Treatment Program can be miles further away than a pharmacy. 

Fiellin mentioned how further legislation could increase access to methadone, specifically the Modernizing Opioid Treatment Access Act, introduced to the U.S. Senate on March 2, 2023. The act would allow certain practitioners to prescribe methadone to be dispensed through a pharmacy rather than an Opioid Treatment Program.

“[The updated regulations] are a movement in the right direction, to start to allow treatment to become integrated into general medical care,” Morford said. 

The final ruling of Part 8 of Title 42 of the Code of Federal Regulations, which revised the methadone regulations, was made on April 2, 2024.