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Randomized Controlled Trial
. 2024 Oct 1;7(10):e2440006.
doi: 10.1001/jamanetworkopen.2024.40006.

Communities That HEAL Intervention and Mortality Including Polysubstance Overdose Deaths: A Randomized Clinical Trial

Bridget Freisthler  1 , Rouba A Chahine  2 , Jennifer Villani  3 , Redonna Chandler  3 , Daniel J Feaster  4 , Svetla Slavova  5 , Jolene Defiore-Hyrmer  6 , Alexander Y Walley  7 , Sarah Kosakowski  7 , Arnie Aldridge  2 , Carolina Barbosa  2 , Sabana Bhatta  8 , Candace Brancato  5 , Carly Bridden  7 , Mia Christopher  2 , Tom Clarke  9 , James David  10 , Lauren D'Costa  2 , Irene Ewing  11 , Soledad Fernandez  12 , Erin Gibson  7 , Louisa Gilbert  10 , Megan E Hall  2 , Sarah Hargrove  5 , Timothy Hunt  10 , Elizabeth N Kinnard  7 , Lauren Larochelle  13 , Aaron Macoubray  2 , Shawn Nigam  5 , Edward V Nunes  14 , Carrie B Oser  5 , Sharon Pagnano  13 , Peter Rock  5 , Pamela Salsberry  15 , Aimee Shadwick  16 , Thomas J Stopka  17 , Sylvia Tan  2 , Jessica L Taylor  7 , Philip M Westgate  5 , Elwin Wu  10 , Gary A Zarkin  2 , Sharon L Walsh  18 , Nabila El-Bassel  10 , T John Winhusen  11 , Jeffrey H Samet  7 , Emmanuel A Oga  2
Affiliations
Randomized Controlled Trial

Communities That HEAL Intervention and Mortality Including Polysubstance Overdose Deaths: A Randomized Clinical Trial

Bridget Freisthler et al. JAMA Netw Open. .

Erratum in

  • Error in Byline.
    [No authors listed] [No authors listed] JAMA Netw Open. 2025 May 1;8(5):e2515507. doi: 10.1001/jamanetworkopen.2025.15507. JAMA Netw Open. 2025. PMID: 40343703 Free PMC article. No abstract available.

Abstract

Importance: The HEALing Communities Study (HCS) evaluated the effectiveness of the Communities That HEAL (CTH) intervention in preventing fatal overdoses amidst the US opioid epidemic.

Objective: To evaluate the impact of the CTH intervention on total drug overdose deaths and overdose deaths involving combinations of opioids with psychostimulants or benzodiazepines.

Design, setting, and participants: This randomized clinical trial was a parallel-arm, multisite, community-randomized, open, and waitlisted controlled comparison trial of communities in 4 US states between 2020 and 2023. Eligible communities were those reporting high opioid overdose fatality rates in Kentucky, Massachusetts, New York, and Ohio. Covariate constrained randomization stratified by state allocated communities to the intervention or control group. Trial groups were balanced by urban or rural classification, 2016-2017 fatal opioid overdose rate, and community population. Data analysis was completed by December 2023.

Intervention: Increased overdose education and naloxone distribution, treatment with medications for opioid use disorder, safer opioid prescribing practices, and communication campaigns to mitigate stigma and drive demand for evidence-based interventions.

Main outcomes and measures: The primary outcome was the number of drug overdose deaths among adults (aged 18 years or older), with secondary outcomes of overdose deaths involving specific opioid-involved drug combinations from death certificates. Rates of overdose deaths per 100 000 adult community residents in intervention and control communities from July 2021 to June 2022 were compared with analyses performed in 2023.

Results: In 67 participating communities (34 in the intervention group, 33 in the control group) and including 8 211 506 participants (4 251 903 female [51.8%]; 1 273 394 Black [15.5%], 603 983 Hispanic [7.4%], 5 979 602 White [72.8%], 354 527 other [4.3%]), the average rate of overdose deaths involving all substances was 57.6 per 100 000 population in the intervention group and 61.2 per 100 000 population in the control group. This was not a statistically significant difference (adjusted rate ratio [aRR], 0.92; 95% CI, 0.78-1.07; P = .26). There was a statistically significant 37% reduction (aRR, 0.63; 95% CI, 0.44-0.91; P = .02) in death rates involving an opioid and psychostimulants (other than cocaine), and nonsignificant reductions in overdose deaths for an opioid with cocaine (6%) and an opioid with benzodiazepine (1%).

Conclusion and relevance: In this clinical trial of the CTH intervention, death rates involving an opioid and noncocaine psychostimulant were reduced; total deaths did not differ statistically. Community-focused data-driven interventions that scale up evidence-based practices with communications campaigns may effectively reduce some opioid-involved polysubstance overdose deaths.

Trial registration: ClinicalTrials.gov Identifier: NCT04111939.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr DeFiore-Hyrmer reported grants from Bureau of Justice Assistance during the conduct of the study. Dr Walley reported grants from National Institutes of Health (NIH) during the conduct of the study; he reported receiving salary support from Massachusetts Department of Public Health for service as medical director of the Bureau of Substance Addiction Services; he received grants from Centers for Disease Control and Prevention as Principal Investigator and from the National Center for Injury Prevention and Control for service on the Board of Scientific Counselors; he received personal fees from American Academy of Addiction Psychiatry for provider clinical support services, REACH as mentor and speaker for overdose prevention webinar, and honoraria from A-G Associates and Substance Abuse and Mental Health Services Administration (SAMHSA) for naloxone saturation webinar outside the submitted work. Dr Bhatta reported grants from Columbia University through the HEALing Communities Study, funded by the National Institute on Drug Abuse (NIDA) during the conduct of the study. Dr Brancato reported grants from NIDA during the conduct of the study. Dr Bridden reported grants from NIDA during the conduct of the study. Dr Larochelle reported grants from SAMSHA to Boston Medical Center Boston Medical Center with Massachusetts Department of Public Health as subrecipient during the conduct of the study. Dr Oser reported grants from NIDA during the conduct of the study. Dr Shadwick reported employment with the Ohio Department of Mental Health and Addiction Services, which was reimbursed for half of her salary during the conduct of the study. Dr Wu reported grants from NIDA during the conduct of the study. Dr Walsh reported grants from NIDA during the conduct of the study; she received personal fees from Astra-Zeneca, Braeburn Pharmaceuticals, Cerevel Therapeutics, Indivior, Kinoxis Therapeutics, Lundbeck, Opiant Pharmaceuticals, and Reacx Pharma outside the submitted work; in addition, Dr Walsh holds a patent issued for method of treatment with tradipitant. No other disclosures were reported.

Figures

Figure.
Figure.. Study Flow Diagram for HEALing Communities in 4 US States
See this image and copyright information in PMC

References

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