UK’s HEAL grant didn’t meet overdose death reduction goal, but still counts successes

The nation’s largest research grant investment to significantly reduce opioid overdose deaths in Kentucky and three other states did not yield the results its researchers set out to achieve, according to the National Institutes of Health.

NIH’s National Institute for Drug Abuse and the University of Kentucky said Sunday the four-year HEALing Communities study ultimately didn’t produce a “statistically significant reduction” in opioid overdose death rates. The results were published on Sunday in the New England Journal of Medicine.

The success of the study — which began in 2019 — was significantly “weakened” in all four states, NIH said, because of the timing of the COVID-19 pandemic and the proliferation of fentanyl, an opioid fatal in small doses, and one that has driven Kentucky’s rate of drug overdose deaths for the last five years. It’s often mixed in with other drugs, including cocaine and methamphetamine.

But Dr. Sharon Walsh, UK’s principal investigator in the study and director of UK’s Center on Drug and Alcohol Research, said distilling the success of the study down to essentially one data point overlooks the many ways their model worked, and their significant strides in lowering overdoses and broadening access to harm reduction measures.

“Trying to bridge that very narrow definition of what’s statistically meaningful versus what’s meaningful clinically, they’re very different things,” Walsh told the Herald-Leader.

While the study did not achieve the specific 40% reduction in overdose deaths researchers had hoped, it did lower those rates; one model UK used shows a 9% reduction, another a 15% reduction, according to Walsh.

“If somebody said this study wasn’t successful because of (this single metric), I would just have to strongly disagree with them,” she said, adding that the study’s findings show that the multi-faceted community coalition strategy “can make a meaningful impact on combating overdoses, even amid the rapidly evolving opioid epidemic and unprecedented disruptions like the COVID-19 pandemic.”

The HEALing Communities study is the largest addiction prevention and treatment implementation study ever conducted.

It took place in 67 communities across Kentucky, Massachusetts, New York, and Ohio — four states that have been among the hardest hit by the opioid crisis.

The project’s total federal cost was $350 million, and Kentucky’s share of that was $89 million.

Kentucky’s charge — spearheaded by a few dozen researchers at the University of Kentucky — was to develop and implement an evidence-based model to reduce opioid overdose deaths by 40% in 16 counties over the course of four years.

The broader goal was then, and still is, to share that model with other communities across the country to lower their own rate of drug deaths.

Researchers and their community partners focused their efforts in a handful of key areas in health and behavioral health care settings and in jails and prisons: reducing stigma around addiction; expanding access to the opioid overdose-reversal nasal spray, naloxone, or Narcan; broaden access to FDA-approved medication for opioid use disorder, like Suboxone and methadone; improve prescription opioid safety practices.

The 16 Kentucky counties targeted by the study were located in central, northern and eastern portions of the state: Fayette, Bourbon, Franklin, Jessamine, Clark, Madison, Boyle, Jefferson, Knox, Floyd, Carter, Boyd, Greenup, Mason, Campbell and Kenton.

COVID-19, fentanyl large drivers in the inability to intervene

Launched in late 2019, a few months before the onset of COVID-19 in March of 2020, research for the HEAL study was just getting started when people were driven indoors and in isolation, exacerbating addiction for many.

This limited in-person access not only dampened researchers’ ability to keep working, forced isolation led to a significant increase in relapse and drug use rates, and lead to fatal overdoses.

In 2021 at the height of the pandemic, 2,250 Kentuckians died of an overdose — a more than 14% increase from the year prior.

Due to the pandemic, only 38% of the planned 615 strategies were put into action before July 2021.

Researchers compared the rate of overdose deaths between the communities that received the intervention immediately with those that did not during the period of July 2021 and June 2022. UK’s data showed a 9% drop in opioid deaths.

In total, UK deployed hundreds strategies to try to reduce overdoses. More than 250 were related to overdose education and NARCAN distribution, 256 related to medications for opioid use disorder, and 105 related to prescription opioid safety, according to the study results.

Fentanyl became more common in illegal drugs, often mixed with stimulants like methamphetamine and cocaine, or in fake pills designed to look like prescription drugs. This rise in fentanyl, along with xylazine, during the study, created new problems for treating opioid addiction and overdose. Xylazine is a non-opioid sedative or tranquilizer, commonly referred to as ‘tranq.’

Finally, the timeline to measure comparisons for the community participants was only 10 months after they were first implemented — a window many saw as too narrow, Walsh said.

How the program succeeded

While the programming did not reach their 40% reduction target in any of the states, including Kentucky, the commonwealth saw a reduced number of deaths in the final two years of the project, not to mention an overall improvement in access to opioid addiction medication and naloxone.

More than 40,000 doses of Narcan were distributed, dozens of peer recovery coaches and care navigators were deployed into communities and given more than $411,000 in transportation support. Thirty-five pharmacies installed permanent medication disposal drop boxes, which has led to the incineration of more than 6,500 pounds of leftover medication. And the study helped pay for 64 treatment resource communication campaigns, which achieved tens-of-millions of individual engagements.

On top of it all, Kentucky’s drug overdose deaths are dropping more quickly than the national rate.

From December 2022 to December 2023, overdose deaths across the country dropped by an estimated 3%, according to the CDC’s data released earlier this month.

That’s the first time the country has reported a decrease in drug overdose deaths in five years.

Kentucky’s drop was even more significant, according to the state’s Office of Drug Control Policy, at 10%. In 2022, Kentucky was one of only eight states that noted a significant decrease in drug deaths, according to the state Office for Drug Control Policy’s 2022 annual report.

Even though the numbers didn’t meet the initial goal, researchers with the project found something to celebrate about the conclusion of the study. To this end, more granular results and findings of UK’s portion of the study will be released in the coming months, Walsh said.

“Even in the face of a global pandemic and worsening overdose crisis, the HEALing Communities Study was able to support the implementation of hundreds of strategies that we know save lives,” said Redonna Chandler, Ph.D., director of the HEALing Communities Study at NIDA.

“This is an incredible feat for implementation science, and shows that when we provide communities with an infrastructure to make data-driven decisions, they are able to effectively implement evidence-based practices based on their unique needs,” Chandler said.

Walsh echoed this and pointed to the strides Kentucky has made in building addiction treatment infrastructure from the ground up in less than a decade, going from one of the most-impacted states from the drug crisis to a leader in combating it.

An East Tennessee State University study in March found Kentucky has more residential addiction treatment beds per capita than any other state in the country.

“We can’t let a single (data point) have us take our foot off the gas,” Walsh said. “We’ve got momentum, and we need to keep it up.”