As the opioid addiction crisis continues in America, there are both new and old medications available to treat it. One of the oldest is methadone. It is also the most stigmatized — and the most regulated.
But many advocates and patients with substance use disorder say methadone can be the most effective option and time has come to make it easier to get.
'I was very, very young'
In April, the federal government relaxed some of the rules around the addiction medication — and experts in western Massachusetts say they are relieved.
But nationally, the uptake has been slow.
Kellyann Kaiser is among those who have benefitted from new flexibility. She said she started using illegal opioids when she was 13.
“I was very, very young. My first detox was 15, I’ve been in and out of halfway houses, detoxes, for quite a while,” Kaiser said.
Kaiser kept using into her late 20s. And at one point, she lost custody of her son. Now 30, she’s tried a lot of different addiction medications.
“I think just methadone is just what got me sober,” she said. “Without that, I think I would still be using.”
But it hasn’t always been easy for her to get the sticky pink liquid that relieves her cravings and stops her from going into withdrawal. At first, the mother of three had to drive an hour from her home in Ware, Massachusetts, to a methadone clinic in Springfield.
“I would either have to bring my children, or I'd have to find a babysitter,” Kaiser said. “Go there and come back. I used to have to go every single day.”
The feds change the methadone rules — after decades
Now, there’s a clinic closer to her home, and Kaiser only has to go once a month. That’s because new federal rules allow her to take methadone bottles home.
Ruth Potee, Kaiser’s doctor at the nonprofit Behavioral Health Network (BHN), is a nationally known advocate for better addiction treatment.
"[Under] the old rules, you had to be in clinic for 90 days and you had to never miss a day to get one bottle [to take home],” Potee said. “So that's a lot of perfection.”
In contrast, newer anti-addiction drugs like Suboxone or Vivitrol can be prescribed in a primary care office, as of 2022. Those medications can’t be abused in the same way as methadone, which is itself an opioid.
But for many people, Potee said, methadone works better against the potent new street drugs like Fentanyl and Xylazine.
“It's a miracle drug. It really makes people feel better,” she said. “It doesn't take any length of time to get on to it. You get to a stable dose and then you stay there. You don't really develop tolerance to it.”
Some of Potee’s patients tell her they’ve stopped using illegal opioids entirely because of methadone.
“Other patients will say, 'When I first met you, I used to use five grams a day or five bundles [of heroin] a day, but now I use sometimes once or twice a week, maybe one bag at a time,'” said Potee, who stresses a harm reduction approach to addiction. “Quite honestly, that's a very small amount.”
A history of restriction — and a step to reverse it
Methadone, which locks onto opiate receptors in the brain, was introduced to treat addiction more than 50 years ago. With methadone’s high street value and potential for abuse, the federal government set up strict rules around how to get it — including daily visits to a high-security methadone clinic, mandatory counseling and an inflexible dosing schedule.
“They just built the rules in this one way that made it incredibly restrictive,” Potee said, “and they never went back to change it, despite decades of increasing addiction.”
That is, until this past spring, when the federal agency that oversees substance abuse and mental health services — called SAMHSA — changed the methadone rules for the first time in decades. Patients still have to get methadone at clinics, but if they meet the criteria, they can take weeks’ worth of bottles home, and providers have more leeway in dosing.
Yngvild Olsen, who directs substance abuse treatment for SAMHSA, said regulators first tried out the new rules as a COVID measure. As she put it, the sky didn’t fall.
“This did not increase the rate of methadone-related mortality, for example, which had been one of the concerns prior to this kind of natural experiment,” Olsen said.
Olsen said SAMHSA put in guardrails to limit abuse and black-market sales. For instance, Kellyann Kaiser said she had to earn the right to get take-home bottles.
“I had to pass so many drug tests,” Kaiser said. “And then you have to take a safety class on what you do with your methadone, how you keep it safe in your home.”
Kaiser credits methadone with helping her regain custody of her son. She credits the new rules with helping her stick to treatment.
Massachusetts has embraced the new flexibility around methadone. Not all places have. The federal standards are voluntary.
“There are some states that are still really looking at and figuring out what's going to work best for their state,” Olsen said.
Olsen said her staff encouraged states to fully adopt the federal guidelines by the voluntary “compliance date” in early October. But many providers say uptake has been frustratingly slow.
“Substance use treatment programs love rules,” said Brian Hurley, who heads the American Society for Addiction Medicine, a professional organization for addiction doctors.
Hurley said the culture of methadone clinics is mired in the way things have always been done. So he’s trying to help individual clinics set up new protocols, starting in Los Angeles where he’s based, “shifting the approach from a rules-based to a patient-centered approach.”
Some pushback on the new flexibility
But there are reasons some providers are going slowly.
“When you look at a whole system of 2,000-plus treatment programs, it's like watching an aircraft carrier change course in the middle of the ocean,” said Mark Parrino, head of the American Association for the Treatment of Opioid Dependence, a trade group for methadone clinics. “It does so, but it does so carefully.”
While Parrino said his group approves of the new flexibility, they worry about liability, since it’s possible to overdose from methadone.
“Methadone is a very therapeutic medication when it's used wisely,” he said. “But if it's used unwisely, it's unforgiving.”
And there’s a financial piece. Parrino said clinics — the majority of them for-profit and funded by private equity — are waiting to see whether Medicaid changes how it pays for methadone treatment when patients come in less frequently.
Otherwise, he said, “the programs absolutely lose money. Some will not be able to continue.”
But in western Massachusetts, BHN's Potee said private equity has not made as many inroads into the lucrative methadone business.
“It's one of the reasons why western Mass. is a shining star when it comes to methadone delivery,” she said, “because there's a lot of not-for-profit entities here, and we're able to understand the rules and put change into effect quite quickly.”
Even so, Potee wishes regulators would put more pressure on clinics to be more flexible and to follow the federal rules.
“I would love for the people that inspect methadone clinics to really sit there and say, ‘Are you open to walk-ins most days a week? Are you dosing methadone appropriately in the age of fentanyl? What percent of your patients get take-home bottles?’”
Potee and other advocates say the new rules don’t go far enough to break the clinics’ monopoly on methadone.
“The regulations are not enough,” U.S. Senator Ed Markey of Massachusetts said in an interview. "They won't be enough until methadone is freed from methadone clinics generally.”
Markey is co-sponsoring legislation called the Modernizing Opioid Treatment Access Act. It would allow patients to get their methadone from any doctor board-certified in addiction medicine and pick it up from a regular pharmacy.
Methadone clinics would no longer be required.
“The bill will unwind outdated, restrictive … policies that impact people trying to stay in recovery,” Markey said. “Push back against private equity and for-profit investors who want to keep methadone locked in methadone clinics for the sake of their own financial bottom line.”
A legacy of stigma
Markey’s bill has support from several provider groups.
Hurley, of the physicians' group, said methadone regulations were born in the 1970s, during President Nixon’s so-called “war on drugs,” when the government embraced a law-enforcement approach to addiction.
Plus, Hurley added, most people using methadone then were low-income and people of color whom, the government believed, had to be managed in a stricter way.
“So I think methadone kind of has this legacy that was shaped out of a very stigmatized time in American history,” Hurley said. “Not that that stigma has gone away, but I think one of the reasons that methadone is so hyper-regulated.”
In contrast, he said, the newer medications like Suboxone — which can now be prescribed by a primary care doctor — are more common in white and suburban communities.
And according to Potee, people in rural areas, like western Massachusetts, are especially vulnerable to relapse if they live far from a clinic.
“Can you get up and drive 45 minutes to a place and take care of your family and the dog and empty the dishwasher and go to work?” she said. “No, you can't do it. And yet we expect that of people who struggle with addiction. It’s completely unreasonable.”
'There will certainly be untoward events'
There is strong opposition to taking methadone out of the clinic’s exclusive domain. Parrino, of the national clinic trade group, said people with addiction need the supervision a clinic provides.
“If you suddenly unleash methadone and you don't have doctors that either have the ability or time to monitor the patients,” he said, “then there will certainly be untoward events.”
But Markey said certified addiction doctors are perfectly able to monitor their patients, and that claiming otherwise is a scare tactic by clinics.
“They are playing hardball,” Markey said. “They have a monopoly on methadone treatment ... Their goal is to ensure that they maintain their monopoly.”
Parrino acknowledged the methadone business is lucrative. But he also said it’s a good thing for-profit companies have stepped in to provide the treatment.
“I understand the critique of, 'Well, private equity is involved.' That's true,” Parrino said. “But you do not have public monies streaming into the system to expand access to care.”
Plus, Parrino said, if legislation pushes private equity out of the methadone business and clinics close as a result, he doubts there would be enough community-based doctors willing to pick up the slack.
Markey disagreed. He said the first step is legalization, and after that, addiction doctors will step up.
Still, even some supporters of Markey’s legislation think it could be stronger. BHN's Potee, for instance, does not think prescribing methadone should be limited to addiction doctors, as the bill stipulates.
“You should be able to walk into your primary care office and get it,” she said.
But Markey said that’s a political bridge too far. He said fighting the methadone clinics is already an uphill battle and loosening the rules even more could doom the measure entirely.
Meanwhile, Potee did not want to wait for new legislation before making methadone more accessible for her patients at BHN, especially those in rural areas.
“I lie in bed staring at maps, thinking, ‘Where else do we need to go to get treatment available to people who need it?'” Potee said.
One solution was a “methadone van” — a mobile clinic, now parked every weekday in a downtown lot in Ware. It’s the first methadone van in western Massachusetts and one of four in the state.
Potee said it took a lot of money and effort to meet federal regulations to open a methadone van, since it had to be licensed by the Drug Enforcement Agency.
“A van feels to them like high vulnerability,” she said. “So there are lots of requirements about how this van could stay secure on the road.”
The van launched in July. Like other methadone clinics, there are security guards standing outside and the medication is kept in a safe. But Potee said the hassle is worth it.
“It's definitely never going to be a moneymaker,” she said. “And yet it was the right approach to take.”
Her goal is to eventually reach the many rural areas of western Massachusetts that are just too far from the brick-and-mortar clinics, since that’s the only other legal way to get this treatment.
BHN had already set up a regular methadone clinic in Orange — and Ware felt like the next priority.
The state reported more than 2,000 deaths from opioid overdoses in 2023 — with 4 deaths in Ware, down from 13 in 2021.
“The addiction rate out here is high and the overdose rate is high,” said Alison Tellierfox, a BHN nurse who coordinates care at the van.
After only a few months, she said, patients are reporting major life changes.
“We have a gentleman who walked up on one of our first walk-in days, and he's starting a job next week. So these are really exciting things for us to hear.”
'Methadone is going to save my life today'
A Ware resident named Tina, in recovery from heroin use, is among the patients relieved the van has opened. (She did not wish to give her last name for privacy.)
Tina, 51, used to have to get rides to a methadone clinic in Springfield, which took about an hour each way. Now it only takes a few minutes for her to walk to the van.
On the first day Tina came for her daily dose at the van, she greeted Potee, who had set up a tent outside the vehicle to prescribe methadone and talk to patients.
“Hi, beautiful. How are you?” Tina said.
Tina said she knows there’s a stigma against methadone, more than other forms of addiction treatment. And she doesn’t care.
“Methadone is going to save my life today,” she said. “And that's all that matters.”
Tina does not yet qualify under the new federal rules to take bottles of methadone home. TellierFox said that’s the case for a number of their patients. She said one man had lost custody of his children but didn’t have a car. Before the van opened, he just couldn’t stick with daily treatment.
“And he showed up on the walk-in day, and it's been amazing,” TellierFox said. “He was using a pack of heroin a day, which is an insane amount of heroin. And he's down to a bundle a day right now.”
That meant he went from 100 bags of heroin a day to about 10.
Tina first heard about the van from an ad in the newspaper. After stepping into the van, she went up to a window to ask for her dose. A nurse passed her a dose in a plastic cup, and Tina tipped it into her mouth while the nurse watched.
“It’s that simple,” Tina said afterwards.
Tina said the van is making a huge difference in her recovery. She’d been trying to stay on methadone for a couple years.
“Transporting to Springfield every single day was quite something,“ she said. “It was hard. It was an inconvenience to me and other people as well.”
Sometimes, she would have to pay for rides. Or she would miss her dose “many, many, many times,” she said. “And I would risk my life many times not coming to do what I need to do …. relapsing time and time again. So I'm here again and I'm trying to do this. And this is beautiful, the van and everything. This is awesome.”
Staying nimble and taking methadone where it’s needed
Not all community members were supportive of the mobile clinic, according to Kaiser, who works at the Ware Recovery Center as well as being a methadone patient herself.
“I feel like a lot of people just looked at it like a bunch of drug addicts are going to go to this area,” she said. “There's a lot of stigma against addiction."
But now, she said, people she knows with addiction have started using methadone treatment simply because the van is parked in Ware.
“I've already seen a few people go there and they weren't on [methadone] before,” Kaiser said. “They couldn’t get there so they just kept using and they felt like there was no other way. But now, it's here and it's so local.”
The mobile clinic did not need official town approval, according to Ware's town administrator, Stuart Beckley. He said the van "has not generated any controversy or concern."
Eventually, Potee and other advocates are hoping methadone clinics — mobile or not — will no longer be necessary, especially if Markey’s legislation passes.
In the meantime, she said, if the van catches on, her agency will consider building a brick-and-mortar clinic in Ware and sending the van to the next rural community that needs it.
