Major nationwide opioid trial fails to meet goals to reduce overdose deaths

An ambitious federal effort to reduce opioid-related deaths through community-based interventions has failed.

Despite educational campaigns, increased distribution of naloxone, improved access to medications for opioid use disorder (MOUD), and many other interventions, the study failed to demonstrate a statistically significant reduction in overdose deaths.

The goal of the large-scale nationwide trial was to reduce opioid overdose deaths by 40% in dozens of communities.

“In retrospect, the pre-specified 40 percent reduction in opioid overdose deaths was clearly ambitious,” the study authors wrote. “The study may not have been sufficiently powered to detect much smaller but clinically meaningful differences.”

According to the authors, several factors likely prevented the study from demonstrating a statistically significant reduction in overdose deaths. These limitations include the relatively short time frame of the intervention, disruptions caused by the COVID-19 pandemic, and the increased prevalence of fentanyl.

The study, called the HEALing Communities Study (HCS), randomly selected 34 communities in Kentucky, Massachusetts, New York and Ohio to implement a series of evidence-based, community-based interventions designed to reduce deaths from opioid overdose.

These communities used over 600 evidence-based strategies, some focused on overdose education and naloxone distribution, others on MOUD use, and others on prescription opioid safety.

The researchers compared these communities with a control group of 33 similar communities in the same states that did not receive these interventions.

In the control communities, the opioid overdose death rate was approximately 51.7 per 100,000 residents between July 2021 and June 2022. In the communities where the intervention was implemented, the death rate was 47.2 deaths per 100,000, a statistically insignificant decrease.

The communities selected to implement the policies had only 10 months to develop partnerships with authorities and implement the initiatives. When the study began collecting data on overdose deaths, only 38% of these strategies had been implemented.

“The time frame was insufficient to initiate many evidence-based practice strategies, which often required recruiting new staff from an increasingly scarce health workforce, modifying clinical workflows, or developing new interagency collaborations to implement services,” the study authors wrote. “Ultimately, 615 strategies were implemented, indicating the effectiveness of the CTH intervention in mobilizing communities to adopt evidence-based practices.

Ultimately, the communities involved in the study implemented 615 strategies. According to the study authors, these demonstrated that efforts to mobilize communities to adopt evidence-based practices were effective.

The COVID-19 pandemic has also “severely disrupted” the systems selected for study participation. This disruption reduced the ability of communities to implement selected interventions and thus reduced the potential for the effectiveness of those interventions.

In addition, the increased prevalence of fentanyl and xylazine may have reduced the impact of the study’s interventions. The authors also note that peaks in fentanyl use may not have been consistent across the communities involved in the study.

According to the authors, the study had several strengths, including the use of current data to provide insight into what interventions were being used and what partnerships had been formed between community agencies, people with first-hand experience, public health practitioners and government officials.

“Although there were no significant differences in the number of opioid overdose deaths between groups, the study demonstrated that CTH’s community-focused intervention, with its use of community coalitions and a data-driven approach, can make significant progress in implementing evidence-based practices,” the study authors wrote.

Another federal study on opioid overdoses, this time focusing on Medicare beneficiaries, was released on the same day as the HEALing Communities Study.

The study, published in JAMA Internal Medicine, found that 17% of Medicare beneficiaries who had suffered a nonfatal overdose suffered another nonfatal overdose within a year. About 1% of these Medicare beneficiaries died from another overdose within a year.

The study also found that opioid interventions, including administration of MOUDs, filling naloxone prescriptions, and accessing mental health services, were all associated with a reduction in the risk of subsequent fatal overdose.

“People who have experienced one overdose are more likely to experience another,” Miriam Delphin-Rittmon, assistant secretary for mental health and substance use at the Centers for Medicare & Medicaid Services and head of SAMHSA, said in a statement. “But we found that when survivors receive gold standard treatment, such as medications for opioid use disorder and naloxone, the odds of dying from an overdose in the following year drop dramatically. In short, medications for opioid use disorder, medications to reverse opioid overdose, and behavioral health supports save lives.”

Although interventions such as MOUDs and naloxone can reduce the risk of death, few Medicare beneficiaries receive these interventions.

Only 4.1% of Medicare beneficiaries who survived an opioid overdose received MOUD and only 6.2% filled a naloxone prescription in the following year, the study found.

“These findings underscore the need to increase the use of evidence-based treatments following nonfatal drug overdose,” the study authors write.