Methadone doses haven’t kept up in the age of fentanyl. A new rule aims to help

Patients beginning treatment for opioid addiction often face excruciating withdrawal symptoms. But for people struggling to transition from ultra-potent illicit fentanyl to comparatively weaker addiction medications, help may be on the way.

A new federal regulation would make it easier for some patients to begin treatment on significantly higher doses of methadone, a key medicine used to treat opioid use disorder.

Current regulations recommend that clinicians start patients on just 30 milligrams of methadone, a dose that experts say would almost universally leave people who regularly use fentanyl in significant discomfort. The new proposal would allow for slightly larger doses — and, more significantly, emphasizes that doctors can use their discretion to go substantially higher, if necessary.

“It’s going to allow a lot of clinicians to make a more individualized assessment,” said Allegra Schorr, the owner of a Manhattan methadone clinic and president of the Coalition of Medication-Assisted Treatment Providers and Advocates (COMPA), a New York advocacy group. “It’s really a matter of finding a dose that’s going to be efficient and effective for a person without risking overdose.”

It remains unclear, however, whether the change will make a meaningful difference. In the fentanyl era, daily methadone doses often reach 150 or even 200 milligrams, meaning an initial dose one-fifth as big might be of little use. Insufficient methadone doses can force patients into unbearable withdrawal — which in turn can force them to continue using illicit substances despite their desire to stop.

While the new regulation eliminates red tape and emphasizes that prescribers should use their best judgment when choosing a starting dose, critics argue that methadone clinics won’t feel truly empowered unless dosing limits — whether they’re guidelines or hard caps — are eliminated altogether.

“Anecdotally, very few OTPs [opioid treatment programs] are practicing outside the guidelines on the starting dose,” said Jessica Taylor, an addiction physician and researcher at Boston Medical Center’s Grayken Center for Addiction. “As long as the guideline recommends 30 milligrams … it’s going to be really hard to move the needle on what’s actually happening.”

The proposed change, and the broader debate surrounding limits on methadone treatment, highlights the fast-shifting landscape in the world of addiction medicine.

In particular, the presence of fentanyl in the U.S. drug supply has upended protocols for treatment using methadone and buprenorphine, the two most common medications used to treat opioid addiction.

Patients beginning buprenorphine treatment often experience “precipitated withdrawal,” a rush of symptoms including pain, anxiety, and stomach problems.

The challenges associated with buprenorphine have only made methadone treatment more important — but methadone treatment, too, has become more difficult in recent years. Fentanyl, the synthetic opioid that has conquered the U.S. drug supply, is so potent that patients who begin methadone treatment at what was once a “standard” now exhibit severe withdrawal symptoms.

The changes proposed by the Substance Abuse and Mental Health Services Administration would force clinicians to jump through fewer hoops before exceeding the 30-milligram recommendation. Now, prescribers can go higher as long as they document their reasoning in the patient’s record.

It also allows all prescribers at a methadone clinic to select an appropriate starting dose — a privilege that was previously restricted to a clinic’s medical director or program director.

Methadone providers have always had the flexibility to use whatever dose they feel is appropriate, Neeraj Gandotra, SAMHSA’s chief medical officer, said in an interview. Any perception to the contrary is “unfortunate,” he said, and the new regulations seek to make clinics’ flexibility even more explicit.

“We have tried to emphasize to the practitioners at these OTPs that, quite frankly, we are not trying to dictate clinical practice from Rockville,” he said, referring to the Maryland suburb where the agency is located. “We’ve certainly tried to strike a good balance of patient care and public safety.”

The proposed changes to dosage caps represent just a tiny sliver of a far broader debate about methadone access. With few exceptions, the drug can only be dispensed at a specialized facility known as an opioid treatment program, known as an OTP or simply “methadone clinic.”

Recently, lawmakers including Sens. Ed Markey (D-Mass.) and Rand Paul (R-Ky.) have called for allowing physicians to prescribe methadone directly to patients, and for allowing patients to pick up the medication at a pharmacy. Many methadone clinics and the trade group that represents them, the American Association for the Treatment of Opioid Dependence, have pushed back.

Experts universally agree that prescribers should exercise caution with methadone, which is itself an opioid sometimes prescribed to treat pain. But many disagree about where to draw the line.

Schorr, the COMPA president, argued that while clinics should work to treat withdrawal as quickly as possible, 40 milligrams is not an unreasonable cap for brand-new patients.

“I think 40 probably is the right number for somebody who you don’t know,” Schorr said. “There’s definitely a danger of over-medicating someone. If you’re talking about somebody brand new, who doesn’t have a chart, hasn’t been on methadone, doesn’t have a medical history.”

Gandotra, SAMHSA’s chief medical officer, also acknowledged that many prescribers may adhere to the dosing recommendations more strictly than necessary because they fear attracting attention from the Drug Enforcement Administration.

“Methadone is highly regulated by our partners at the DEA as well,” Gandotra said. Providers that exceed dosage guidelines, he said, fear that they’ll “trigger some extra scrutiny. … The rules are in place, actually, to protect providers from that scrutiny.”

While Gandotra highlighted that doctors have long had the discretion to determine initial doses, other physicians argued that the current SAMHSA regulations are a far larger obstacle than the agency acknowledges.

Under-treating patients carries serious consequences, experts say. Severe withdrawal often leads to continued use of illicit substances, including fentanyl — which itself often leads to overdose and sometimes death.

It is unrealistic to expect patients beginning methadone treatment at almost any dose to immediately stop using illicit opioids, said Ruth Potee, an addiction physician who runs several nonprofit OTPs in western Massachusetts.

But especially low doses result in especially severe withdrawal, she said. Often, a new patient’s withdrawal symptoms will be so severe that her concern is not whether they’ll continue using fentanyl — it’s how much.

Potee’s message to new patients: “What I think is going to happen is you’re going to continue to use, and my suggestion to you is that you use less than you used yesterday. As I’m titrating up on your methadone, you need to start titrating down on your fentanyl.”

The nuances and immense variability in how patients respond to methadone treatment make any dosing recommendations effectively pointless, said Taylor, the Boston Medical Center clinic director.

More broadly, she argued, they serve as a case study in “methadone exceptionalism.” While countless other medications carry serious side effects and even the risk of death if prescribed carelessly, methadone still stands alone in its degree of government oversight.

“Legislating a dose is something that you wouldn’t imagine for insulin, for example,” she said. “In the case of insulin, using too high a dose is extremely dangerous. You could kill a patient with too much insulin. And yet the government hasn’t instituted guidelines or restrictions on a physician’s choice of initial insulin dose.”

Quality care, Potee said, comes down to evaluating patients based on their circumstance — a task that addiction doctors are more than capable of even without dosage guidelines.

“You sit with people, you hear their story, you hear their other medical conditions and the medicines that they’re on, and you make clinical decisions that are smart,” Potee said. “Because most people in my line of work are not stupid people.”

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