Caught between the “more methadone” and “fewer OTPs” scuffle – Addiction Treatment Forum

In the middle of the summer, Nora Volkow, M.D., medical director of the National Institute on Drug Abuse (NIDA), wrote a blog calling for methadone to be more available in the era of fentanyl. “People with an opioid use disorder (OUD) urgently need treatment not just to protect them from overdosing but also to help them achieve recovery, but highly effective medications like buprenorphine and methadone remain underused,” she wrote. “Amid this crisis, it is critical that methadone, in particular, be made more accessible, as it may hold unique clinical advantages in the age of fentanyl.” 

While Volkow’s call to increase the availability of methadone treatment isn’t new, it comes amid the controversy which has been brewing over years: whether to make methadone more available by increasing access to opioid treatment programs (OTPs), or on the far end of the spectrum by leaving the OTP option behind and “liberating” methadone in a variety of ways. Predominantly, the way recommended by the establishment does not include eliminating OTPs, but does include, as a bill before Congress proposes, allowing physicians to prescribe methadone for OUD and patients to pick up the medication at a pharmacy. There are many problems with this proposal:

In the studies Volkow cited which prove methadone’s benefits, most patients were treated in OTPs (in the United States, that is the only legal place for patients with OUD to receive methadone).

“Methadone may even be preferable for patients considered to be at high risk for leaving OUD treatment and overdosing on fentanyl,” stated Volkow. She said that more research is needed on optimal dosing in an age of fentanyl (higher doses of methadone are required, and buprenorphine may not be effective compared to methadone), and on induction protocols.

The fact is, however, that the Substance Abuse and Mental Health Administration (SAMHSA) has already issued rules which greatly increase the flexibility of OTPs and make access much easier for patients (see https://atforum.com/2024/06/aatod-2004-conference-new-flexible-regulations-and-threat-from-motaa/). This proposal took a lot of wind out of the sails of the “liberate methadone” movement.

Volkow touts the SAMHSA changes in her blog. “The new rule makes permanent the increased take-home doses of methadone established in March 2020 during the COVID pandemic, along with other provisions aimed to broaden access like the ability to initiate methadone treatment via telehealth,” she writes. “Those changes that were implemented during the COVID pandemic have not been associated with adverse outcomes,” she added.

What she does not say is that OTPs themselves made the COVID-era changes safe. OTPs had to decide which patients who were “less than stable” could receive take-home doses above the previous limits, and how many days of take-home doses. This required a degree of competence in treating OUD with methadone, and in knowing the patients, which is standard in OTPs but far from it in general medicine, where physicians have never prescribed methadone for OUD in this country. Never. Zero experience.

Volkow pays tribute to this feeling. “The U.S. still restricts methadone prescribing and dispensing more than most other countries, but worries over methadone’s safety and concerns about diversion have made some physicians and policymakers hesitant about policy changes that would further lower the guardrails around this medication,” she concludes. “Methadone treatment, whether for OUD or pain, is not without risks. Some studies have found elevated rates of overdose during the induction and stabilization phase of maintenance treatment, potentially due to starting at too high a dose, escalating too rapidly, or drug interactions.”

Starting at too low a dose, of course, means patients will have to resort to the street – and illicit fentanyl – to supplement until their OTP-dispensed dose reaches the best therapeutic level.

Still Volkow says methadone can be dispensed in pharmacies safely. NIDA is behind this model, which was published by the American Society of Addiction Medicine, a highly beneficial organization which nevertheless has taken a strong anti-OTP stance in advocating for its members: buprenorphine prescribers.

“Critics of expanded access to methadone outside OTPs sometimes argue that the medication should not be offered without accompanying behavioral treatment,” Volkow writes. She’s not in favor of this. “Data suggest that counseling is not essential. In wait-list studies, methadone treatment was effective at reducing opioid use on its own, and patients stayed in treatment,” she writes. But she’s not willing to commit 100% to that position, adding, “However, counseling may have benefits or even be indispensable for some patients to help them improve their psychosocial functioning and reduce other drug use.” The solution? More research, says Volkow, whose agency funds research. “How to personalize the intensity and the level of support needed is a question that requires further investigation.”

And finally, there is the bugaboo of the “silo.” Volkow objects to methadone treatment – and indeed to all addiction care – being in a silo. “It is time to make this effective medication more accessible to all who could benefit,” she writes. “Although more research would be of value, the initial evidence suggests that providing methadone outside of OTPs is feasible, acceptable, and leads to good outcomes.”

And that’s her last sentence.

Stay tuned. Politicians on Capitol Hill seem less fond of the idea of “liberating methadone.”