Improving Access to Naloxone to Prevent Opioid Overdose Deaths Within Community-based Programs that Serve People Who Use Drugs

: We propose to conduct a randomized controlled trial to test the effectiveness and cost -effectiveness of a multi-component implementation strategy designed to increase and improve naloxone distribution in community-based programs that reach people who use drugs (CBP-PWUD) throughout California. For more than a decade, opioid overdose mortality rates have continued to increase, yet overdose fatalities are preventable with the timely administration of naloxone. Building on pilot work (R21DA046703; Principal Investigator: Lambdin), we will use the Systems Analysis and Improvement Approach to improve access to naloxone from CBP-PWUD (SAIA-Naloxone). In our pilot study with two CBP-PWUD in California, we found that SAIA-Naloxone led to an average increase of 23 more people receiving naloxone (p<0.001) and 64 more naloxone doses being distributed (p<0.001) per week. SAIA-Naloxone was feasible and acceptable, and it resulted in meaningful improvements in naloxone saturation. We are now proposing to test SAIA-Naloxone in a large-scale randomized controlled trial. To effectively address opioid overdoses, CBP-PWUD based naloxone programs must engage participants in a series of sequential steps including screening participants; training them in naloxone administration; distributing naloxone; and building systems that support participants to possess naloxone, use naloxone during overdose events, and obtain naloxone refills as needed. This paradigm is known as the naloxone delivery cascade. SAIA-Naloxone is a multicomponent implementation strategy designed to help CBP-PWUD identify and address weaknesses along the naloxone delivery cascade. It includes determination of drop-offs in cascade delivery, process mapping and consensus discussions to identify potential solutions, and continuous quality improvement. Our Aim 1 is to test the effectiveness of SAIA-Naloxone on improving naloxone distribution at CBP-PWUD, relative to treatment as usual. Aim 3 is to estimate the cost and cost-effectiveness of SAIA-Naloxone on improving access to naloxone, relative to treatment as usual. This project will directly address the overdose mortality crisis. The proposed study aligns with the goals of the Department of Health and Human Services, which recognize naloxone access as our nation’s first defense to prevent opioid overdose deaths.