Treatment policies for opioid addiction differ from drug abstinence

FOr for as long as the federal government has worked to support substance abuse treatment, it has worked from a simple premise: the goal of addiction medicine is to help people stop using drugs – completely and forever.

But with more than 100,000 Americans dying from drug overdoses every year, the Biden administration appears to be changing course. In recent years, major federal agencies have quietly but significantly opened the door to addiction treatment, which, while still focused on eliminating substance use entirely, recognizes that total abstinence may not always be within reach.

In public statements, agency guidelines, new regulations, and even instructions to pharmaceutical companies on how to develop new addiction treatments, the federal government is making it increasingly clear that even if abstinence is not possible, it welcomes secondary and often similar treatment. meaningful endpoint: simply reduce 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, considering any instance of illegal fentanyl use as potentially life-threatening . . “The obvious metaphor is Russian roulette: instead of taking 28 doses of fentanyl a week, you take four – you can still die from it, but the chances go down. So it’s just a simple statistical matter.”

The changes reflect the rapidly evolving climate in addiction medicine, where harm reduction, or practices designed to reduce the most acute harms of substance use among active drug users, is becoming increasingly prevalent.

The policy is in line with the Biden administration’s unprecedented embrace of harm-reduction tactics. But they are also different: harm reduction often focuses specifically on reducing risks in people who do not seek treatment by offering needle exchange, test strips or even controlled drug use. The new policy, on the other hand, explicitly focuses on people seeking addiction care in a medical setting. According to addiction treatment providers and people who use drugs, the new actions by government agencies simply codify a common-sense concept: that using treatment to significantly reduce drug use can significantly reduce risk, even if a patient’s drug use is not stops completely.

“I don’t think the public understands how meaningful a reduction in use could be,” said David Frank, a medical sociologist and researcher at NYU. “Just as they may have seen with drinking, the difference between drinking on the weekend and drinking every day can be dramatic. The same could be true, and perhaps even more so, with illegal drugs.”

In an interview, Brian Hurley, a Los Angeles public health official and president of the American Society of Addiction Medicine, compared historical restrictions on addiction treatment — which sometimes led to the exclusion of patients who continued to use drugs from health care programs — to telling people with diabetes would be taken off treatment if their blood glucose levels rose.

ASAM has also shifted its focus to people who have sought help for a substance use disorder but have not completely eliminated their illicit drug use, even issuing preliminary clinical guidance to increase patient engagement and retention. t reduced their drug use to zero.

“I’m an addiction psychiatrist and I would like my patients to be completely abstinent,” Hurley said. “But I’m definitely going to continue to work with people to make progress, and progress will look different for different people. It might mean working with people who say, “I’m going to stop taking this drug, but not that drug.” That might be very useful and life-saving for you. We can work on that together.”

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

One funded by NIDA studytouted by the agency in January, specifically focused on the transition 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 on accessible care in an effort to ‘meet people where they are’. In addition, it recently completed a major overhaul of methadone clinic regulations, which in many cases recognizes that patients will not achieve complete abstinence, and certainly not immediately.

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

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

Perhaps most notably, the Food and Drug Administration issued guidelines last year stating that pharmaceutical companies working on treatments for meth and cocaine addiction can submit research data on endpoints other than total abstinence.

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

The agency noted that it was often “impractical” to accurately measure the number of applications per day or the amount used. Instead, the agency suggested potentially measuring the number of days an individual goes without use in a given period as a surrogate endpoint of whether a drug treatment is working.

Although technical, the changes differ significantly from the FDA’s typical position of using abstinence as the primary or sole endpoint used to evaluate addiction medications.

The overall changes within the federal government, Hurley said, are not just symbolic.

“I think they are substantive, but they are only as effective as they are put into practice,” Hurley said. In some cases, he warned, changes in federal policy may not translate into changes in the patient experience, citing as an example SAMHSA’s methadone clinic reforms — and the attendant skepticism that state-level regulators and individual clinics their practices will change to take advantage of the flexibility offered by the federal government. regulations now offer.

Likewise, Volkow, NIDA’s director, acknowledged that the federal government had evolved — but said the changes did not go far enough.

“There have been incredible shifts, and the Covid pandemic has been one of the positives – that it changed the very limited ways in which we were allowed to treat people with opioid use disorder,” she said.

But in some cases, such as with the FDA, she expressed skepticism.

“I appreciate them doing their best,” she said. “They say they would consider alternative outcomes, but it is very clear that the most important outcome – and the most important outcome is the one needed to get approval – is abstention.”

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