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There was little improvement in opioid-related overdose deaths with community-based interventions, according to a multisite cluster randomized trial, although the study was met with several obstacles.

In an intention-to-treat analysis, rates of opioid-related overdose deaths were similar between the intervention group and the control group (47.2 deaths vs 51.7 per 100,000 population) across 67 study communities over a 12-month comparison period, reported Jeffrey H. Samet, MD, MPH, of Boston Medical Center, and colleagues in the HEALing Communities Study at the National Institute on Drug Abuse (NIDA).

Those rates corresponded to an adjusted rate ratio of 0.91 (95% CI 0.76-1.09, P=0.30), they stated in the . The findings also were reported at the annual meeting.

The study's evidence-based practices focused on "increasing opioid education and naloxone distribution, enhancing access to medication for opioid use disorder, and safer opioid prescribing and dispensing. The intervention also included a series of communication campaigns to help reduce stigma and increase the demand for evidence-based practices," according to a .

The authors found that intervention effectiveness on the rate of opioid-related overdose deaths did not appear to differ based on location or participant demographics, including age, sex, and race or ethnic group.

They had prespecified a 40% reduction in the rate of overdose deaths related to opioids between the two groups, but conceded post-study that such a target was "clearly ambitious. The trial may have been underpowered to detect substantially smaller yet clinically meaningful differences."

Co-author Redonna Chandler, PhD, director of the HEALing Communities Study, told 番茄社区app that the study had a January 2020 start-date, so just 2 months before the COVID-19 shutdowns. "The COVID pandemic had a huge impact on our community members and all the settings where we were trying to implement the evidence-based interventions," she stated.

Chandler explained the researchers had just 10 months before the comparison period to establish community partnerships and to implement evidence-based practices. As a result, the time frame did not allow them to properly initiate many proposed programs with the intervention groups, which required recruiting new staff, updating clinical practice workflows, and developing new collaborations within community groups.

And Chandler noted that effects of the interventions may have also been tempered by the rapidly evolving illicit drug market, especially with the emergence of new drug mixtures such as fentanyl and xylazine. NIDA Director Nora D. Volkow, MD, stressed in the press release that in "the era of fentanyl and its increased mixture with psychostimulant drugs, it's clear we need to continue developing new tools and approaches for addressing the overdose crisis."

To conduct the 4-year , the researchers selected 806 evidence-based practice strategies to be implemented in communities across Kentucky, Massachusetts, New York, and Ohio. The communities were randomly assigned to receive selected interventions (n=34) or to be added to a wait-list control group (n=33). The communities in the intervention group then selected the strategies they wanted to implement.

Strategies were put in place using the Reach, Effectiveness, Adoption, Implementation, and Maintenance () framework and the Practical, Robust Implementation and Sustainability Model () implementation-science framework.

The interventions were implemented into the assigned communities between January 2020 and June 2022, then a 12-month comparison period was conducted from July 2021 to June 2022. In total, the intervention group implemented 615 out of the 806 strategies: 254 involved overdose education or naloxone distribution, 256 involved the use of opioid use disorder medications, and 105 involved prescription opioid safety.

However, only 38% of these strategies were underway before the comparison period began in July 2021, the researchers said, and during that comparison year (July 2021 through June 2022) across communities, 4,517 deaths were linked with opioid overdoses. After the comparison period, the control communities received interventions from July 2022 through December 2023.

Still, the intervention did yield some benefits. First, Samet's group found that the risk for adverse events (AEs) -- defined as the number of opioid-related emergency medical service runs -- were similar in the two groups, with none of the AEs, serious or otherwise, attributed to the study intervention.

Then, Chandler highlighted that "we found ways to build partnerships between healthcare, behavioral health and criminal legal systems. The hospital and the primary care providers and the jail and the mental health provider and the substance abuse treatment programs were all working together in a harmonized way."

"We feel like we have a game plan," she noted.

Chandler said that longer-term implementation, along with ongoing quality improvement, could have led to better results. In fact, she noted many of the states with intervention communities have seen noticeable declines in overdose deaths. The researchers are conducting follow-up analysis to determine whether the trial's interventions may have played a role in those declines.

"Those takeaways are still evolving," Chandler said. "We're going to have hundreds of findings from this trial -- some have been published and some are in process."

"In terms of the main study finding, we did find that we were able to implement the study and that we were able to get evidence-based practices -- with known ability to reduce overdose fatality -- into communities," she added.

Miriam E. Delphin-Rittmon, PhD, HHS Assistant Secretary for Mental Health and Substance Use, emphasized in the press release that the "implementation of evidence-based interventions is critical to addressing the evolving overdose crisis. This study recognizes there is no quick fix to reduce opioid overdose deaths. Saving lives requires ongoing commitment to evidence-based strategies."

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