Opioid addiction treatment policy is moving away from drug abstinence

For, as long as the federal government has worked to support addiction treatment, it has operated on a simple premise: the goal of addiction medicine is to help drug users stop using drugs – completely and permanently.

But with more than 100,000 Americans dying from drug overdoses each year, the Biden administration appears to be changing tack. In recent years, key federal agencies have quietly but significantly opened the doors to addiction treatment, which, while still focused on completely eliminating substance use, recognizes that complete abstinence is not always within reach.

In public statements, official agency guidance, new regulations, and even instructions to drug companies on developing new addiction treatments, the federal government is making it increasingly clear that even if abstinence is not possible, it welcomes secondary and often similar treatments . significant endpoint: simply limiting use.

“Ideally, people should not be exposed to a situation that could lead to overdose and death,” said Nora Volkow, director of the National Institute on Drug Abuse, calling every case of illegal fentanyl use 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 is lower. So it’s just a simple statistical issue.”

The changes reflect a rapidly changing climate in addiction medicine, where harm reduction, or practices aimed at reducing the most serious harms of substance use among people who actively use drugs, is becoming more fashionable.

This policy is consistent with the Biden administration’s unprecedented adoption of harm reduction tactics. But they are also different: harm reduction often focuses specifically on reducing risk among people who do not seek treatment, by offering syringe exchanges, drug test strips, and even supervised drug use. In turn, the new rules clearly focus on people seeking medical care for addictions. According to addiction treatment providers and drug users, the new actions by government agencies simply codify a commonsense concept: that using treatment to significantly reduce drug use can significantly reduce risk even if a patient’s drug use does not completely end.

“I think society doesn’t understand how significant reducing use can be,” said David Frank, a medical sociologist and researcher at New York University. “The same thing they may have seen with drinking: the difference between drinking on the weekends and drinking every day can be dramatic. The same, or perhaps even more so, could be true for illicit drugs.”

In an interview, Brian Hurley, a Los Angeles public health official and president of the American Society of Addiction Medicine, compared historic restrictions on addiction treatment – which sometimes led to patients who continued to use drugs being kicked out of care programs – to informing people suffering from diabetes would be removed from treatment if their blood glucose levels rose.

ASAM also changed its tone towards people who sought help for substance use disorders but did not fully eliminate their use, even publishing a draft clinical guidelines document to increase engagement and retention rates for patients who had not. they reduced their drug use to zero.

“I am an addiction psychiatrist and I would love for my patients to be completely abstinent,” Hurley said. “But I will definitely continue to work with people to make progress, and progress will look different for different people. This may mean working with people who say, “I’ll stop using this drug, but not that drug.” This can be really helpful and lifesaving for you. We can work on this together.”

Since President Biden took office in 2021, several federal agencies that oversee addiction treatment have also unveiled new policies that signal a new willingness to support addiction treatment approaches that significantly reduce drug use, without eliminating it entirely.

One funded by NIDA testtouted by the agency in January, focused specifically on the shift from “heavy use” to “less frequent use” of methamphetamine and found that reducing use was linked to lower levels of craving and depression.

In December, the Substance Abuse and Mental Health Services Administration issued an advisory regarding lower barrier care striving to “meet people where they are.” Separately, it recently completed a major reform of the regulations governing methadone clinics, which in many cases recognize that patients will not achieve complete abstinence, especially not immediately.

In its new guidance, the agency cautioned against using positive drug test results for “punitive” purposes – in other words, punishing patients who are not yet abstinent – 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 that offer crisis management services – basically paying people to stop using methamphetamine or cocaine. In many cases, programs rely on negative tests for stimulants – in other words, complete abstinence from these drugs. But the largest program of its kind in California makes it clear that it does not punish people who continue to use other drugs. Under the program’s rules, a patient who used to use fentanyl and methamphetamine would continue to receive rewards if they stopped using methamphetamine but continued using fentanyl.

Perhaps most importantly, last year the Food and Drug Administration issued guidance saying that pharmaceutical companies working on treatments for methamphetamine and cocaine addiction can submit clinical trial data on endpoints other than complete abstinence.

“We have previously reported that a sustained period of negative urine toxicology tests indicating abstinence may be a valid surrogate for clinical benefit,” they wrote in their guidelines. “However, the FDA does not and does not recommend that the only appropriate endpoint based on urine toxicology results is the number of patients who achieve complete abstinence.”

The agency noted that it was often “impractical” to accurately measure the number of uses per day or the amount used. Instead, the agency suggested potentially measuring the number of days a person misses in a given period as a surrogate endpoint for determining treatment effectiveness.

These changes, while technical, represent a significant departure from the FDA’s typical position of abstinence being the primary or only endpoint used in evaluating addictive drugs.

Hurley said the overall changes to the federal government are not just symbolic.

“I think they are substantive, but they are only effective if they are put into practice,” Hurley said. He warned that in some cases, changes in federal policy may not translate into changes in patient experiences, citing SAMHSA’s methadone clinic reforms as an example – and the accompanying skepticism that state-level regulators and individual clinics will change their practices to take advantage of the flexibility that federal regulations currently offer.

Similarly, Volkow, the NIDA director, acknowledged that the federal government had evolved but said the changes had not gone far enough.

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

However, in some cases, such as the FDA, has expressed skepticism.

“I appreciate they are trying to make an effort,” she said. “They say they would consider alternatives, but it is very clear that the primary outcome – and the primary outcome is the one necessary for consent – ​​is abstinence.”

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