Drug treatment that insists on abstinence? Federal agencies are just ...

1 Jun 2024

For as long as the federal government has worked to support substance use treatment, it has operated on a simple premise: Addiction medicine’s objective is to help people using drugs stop — completely and forever.

But with over 100,000 Americans dying of drug overdose each year, the Biden administration appears to be changing its tack. In recent years, key federal agencies have quietly but significantly opened the door to addiction treatment that, while still oriented toward eliminating substance use altogether, acknowledges that total abstinence may not always be within reach. 

In public statements, official agency guidance, new regulations, and even in instructions to pharmaceutical companies about how to develop new addiction treatments, the federal government is increasingly making clear that, even if abstinence isn’t possible, it welcomes a secondary and often similarly meaningful endpoint: simply reducing use. 

“Ideally, you don’t want people to expose themselves to a situation that could lead to overdoses and death,” said Nora Volkow, the director of the National Institute on Drug Abuse, casting every instance of illicit fentanyl use as potentially life-ending. “The obvious metaphor is Russian roulette: Instead of taking 28 doses of fentanyl a week, you take four — it can still kill you, but the probability goes down. So it’s just a simple statistical matter.” 

The changes reflect the fast-evolving climate in addiction medicine, in which harm reduction, or practices meant to limit the most acute harms of substance use among active drug users, is increasingly in vogue. 

The policies are in line with the Biden’s administration’s unprecedented embrace of harm-reduction tactics. But they are also distinct: Harm reduction often focuses specifically on reducing risks among people who aren’t seeking treatment by offering syringe exchange, drug testing strips, or even supervised drug consumption. The new policies, by contrast, explicitly focus on people seeking addiction care in a medical setting. According to addiction treatment providers and people who use drugs, the government agencies’ new actions simply codify a commonsense concept: That using treatment to significantly curtail drug use can significantly reduce risk, even if a patient’s drug use doesn’t fully stop. 

“I think the public doesn’t understand how meaningful a reduction in use could be,” said David Frank, a medical sociologist and researcher at NYU. “Just like maybe they’ve seen with drinking: The difference between drinking on the weekends and drinking every single day can be dramatic. The same thing could be true, maybe even more so, with illegal drugs.” 

In an interview, Brian Hurley, a Los Angeles public health official and the president of the American Society of Addiction Medicine, likened historical restrictions on addiction treatment — which sometimes led to patients who continued using drugs being ejected from care programs — to telling people with diabetes they’d be removed from treatment if their blood-glucose levels increased.  

​​ASAM, too, has shifted its tone toward people who have sought help for a substance use disorder but haven’t fully eliminated their illicit drug use, even issuing a draft clinical guidance document to boost engagement and retention levels for patients who haven’t cut their drug use to zero. 

“I’m an addiction psychiatrist, and I would love for my patients to be fully abstinent,” Hurley said. “But I’m absolutely going to continue to work with people to make progress, and progress is going to look different for different people. It might mean working with people who say, ‘I’m going to stop using this drug but not that drug.’ That might actually be really helpful and lifesaving for you. We can work on that together.” 

Several federal agencies that oversee addiction treatment have also put forth new policies since President Biden took office in 2021 that signal a new willingness to support modes of addiction treatment that meaningfully reduce drug use without eliminating it altogether. 

One NIDA-funded study, touted by the agency in January, focused specifically on transitioning from “high use” to “lower use” of methamphetamine, and found that a reduction in use was associated with lower levels of craving and depression. 

In December, the Substance Abuse and Mental Health Services Administration issued an advisory about lower-barrier care in an effort to “meet people where they are.” Separately, it recently completed a sweeping reform of the regulations governing methadone clinics, which in many cases acknowledge that patients will not achieve full abstinence, especially not right away. 

In its new guidance, the agency warned against using positive drug test results “punitively” — in other words, punishing patients not yet abstinent — and Yngvild Olsen, a top SAMHSA official, has called for a “culture change” at methadone clinics nationwide. 

Another federal agency, the Centers for Medicare and Medicaid Services, has approved numerous waivers for state programs to offer contingency management services — in essence, paying people to stop using methamphetamine or cocaine. In many cases, the programs are structured around negative stimulant tests — in other words, total abstinence from those drugs. But the largest such program, in California, makes clear it does not penalize people who continue to use other drugs. According to program rules, a patient who once used fentanyl and meth would continue to receive rewards if they stopped using meth but continued to consume fentanyl. 

Perhaps most notably, the Food and Drug Administration issued guidance last year saying pharmaceutical companies working on treatments for meth and cocaine addiction could submit trial data on endpoints other than total abstinence. 

“We have previously advised that a sustained period of negative urine toxicology findings, indicating abstinence, could be a valid surrogate for clinical benefit,” the agency wrote in its guidance. “However, FDA does not, and has not, advised that the only appropriate endpoint based on urine toxicology results is the number of subjects achieving complete abstinence.”

The agency noted that it was often “impractical” to accurately measure the number of uses per day or the quantity being used. Instead, the agency suggested potentially measuring the number of days an individual does not use in a given period as a surrogate endpoint whether a medication treatment is working. 

Though technical, the changes are a significant departure from the FDA’s typical stance of using abstinence as the primary, or only, endpoint used to evaluate addiction medications. 

The overall changes across the federal government, Hurley said, aren’t just symbolic. 

“I do think they’re substantive, but they’re only as effective as they’re operationalized on the ground,” Hurley said. In some cases, he warned, federal policy changes may not translate to changes in patient experience, citing as an example SAMHSA’s methadone clinic reforms — and accompanying skepticism that state-level regulators and individual clinics will change their practices to exercise the flexibilities that the federal regulations now offer. 

Similarly, Volkow, the NIDA director, acknowledged that the federal government had evolved — but said the changes haven’t gone far enough. 

“There have been incredible shifts, and the Covid pandemic, that was one of the positive aspects — that it shifted the very constrained ways by which we were allowed to treat people with an opioid use disorder,” she said. 

But in some cases, like the FDA, she expressed skepticism.

“I’m appreciative that they are trying to make an effort,” she said. “They say they would consider alternative outcomes, but it’s very clear that the main outcome — and the main outcome is the one that’s necessary to get approval — is abstinence.” 

STAT’s coverage of chronic health issues is supported by a grant from Bloomberg Philanthropies. Our financial supporters are not involved in any decisions about our journalism.

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