Effect of the Communities That HEAL Intervention on Overdose Education and Naloxone Distribution: A Cluster-Randomized, Wait-List Controlled Trial.

Abstract

<b>Objectives.</b> To determine whether the Communities That HEAL (CTH) intervention is effective in increasing naloxone distribution compared with usual care. <b>Methods.</b> The HEALing (Helping to End Addiction Long-Term) Communities Study (HCS) is a cluster-randomized, parallel-arm, wait-list controlled implementation science trial testing the impact of the CTH intervention on increasing the use of evidence-based practices to lower opioid-related overdose deaths. Communities (n = 67) highly impacted by opioid overdose in Kentucky, Massachusetts, New York, and Ohio were allocated to CTH intervention (n = 34) or wait-list comparison (usual care; n = 33) arms. The primary outcome for this study was the number of naloxone units distributed in HCS communities during the comparison period (July 1, 2021‒June 30, 2022), examined using an intent-to-treat negative binomial regression model. <b>Results.</b> Naloxone distribution was 79% higher in the CTH intervention versus usual care arm (adjusted relative rate = 1.79; 95% confidence interval = 1.28, 2.51; <i>P</i> = .001; adjusted rates of naloxone distribution 3378 vs 1884 naloxone units per 100 000 residents), when controlling for urban‒rural status, state, baseline opioid-related overdose death rate, and baseline naloxone distribution rate. <b>Conclusions.</b> The CTH intervention increased naloxone distribution compared with usual care in communities highly impacted by the opioid crisis. <b>Trial Registration.</b> ClinicalTrials.gov identifier: NCT04111939. (<i>Am J Public Health</i>. 2025;115(1):83-94. https://doi.org/10.2105/AJPH.2024.307845).