Single-step versus multi-step intranasal naloxone devices for overdose response: A randomized usability study

Bottom line

Untrained lay responders using a single-step intranasal naloxone device completed critical steps far more often (85% vs 20%) and faster (30s vs 58s) than those using an improvised multi-step kit; brief structured education closed the accuracy gap (100% vs 90%, not significant) but not the speed gap (22s vs 35s; p = .002), device simplicity matters most when structured training cannot be guaranteed.

PICO at a glance

• Population: Adults with no prior naloxone training, recruited within a single urban emergency department.
• Intervention or exposure: Naloxone administration using a commercially manufactured single-step intranasal device during a standardized simulated overdose scenario.
• Comparator: Naloxone administration using an improvised multi-step intranasal kit requiring assembly, same simulated scenario.
• Outcomes: Primary: successful completion of all predefined critical steps, measured pre- and post-education. Secondary: time to successful administration; participant-reported usability (results not detailed in the abstract).
• Study design: Randomized usability study.

Clinical question and design

Take-home naloxone distribution is a cornerstone harm-reduction strategy in emergency departments and community programs aimed at preventing opioid overdose deaths. Intranasal naloxone is dispensed either as a commercially manufactured single-step device or as an improvised multi-step kit that requires assembly before use. Because most people who witness or experience an overdose have no formal training, device complexity itself could be the difference between a successful reversal and a fatal delay, yet usability specifically among likely first responders had not been well characterized before this trial.

This was a randomized usability study conducted in a single urban emergency department. Participants with no prior naloxone training were randomized to administer naloxone using either the single-step device or the multi-step kit during a standardized simulated overdose scenario designed to test first-use usability. Forty participants were enrolled, 20 per group. Outcomes were measured both before and after a brief structured educational intervention. The paper describes the device workflows and participant characteristics. It does not name device brands. The distinction is between a single-step device and an improvised multi-component kit, not a demonstrated comparison of named commercial products.

Intervention and outcomes measured

The intervention was a commercially manufactured single-step intranasal naloxone device, compared with an improvised multi-step intranasal kit requiring assembly, both tested in the same standardized simulated overdose scenario. The primary outcome was successful completion of all predefined critical steps, assessed pre-education and again after a brief structured educational intervention. Secondary outcomes were time to successful administration and participant-reported usability.

Results

In the pre-education simulation, 17 of 20 participants (85%) assigned to the single-step device successfully completed every critical step, compared with 4 of 20 (20%) assigned to the multi-step device, a risk difference of 65 percentage points (95% CI, 42-83; p < .001). Administration was also faster with the single-step device: median 30 seconds (IQR 24-38) versus 58 seconds (IQR 45-75; p < .001).

Safety and additional findings

After the brief structured educational intervention, success rates rose sharply in both arms and were no longer statistically different, 100% with the single-step device versus 90% with the multi-step device (p = .29). Speed remained a persistent advantage for the single-step device even after training: median 22 seconds (IQR 18-29) versus 35 seconds (IQR 28-47; p = .002). Participant-reported usability results are not detailed in the abstract; no adverse-event or safety data are reported.

Uncertainty and limitations

The randomized simulated-usability study enrolled 40 participants (median age 40.5 years [IQR 31-56]; 55% female). The paper describes a commercial single-step device and an improvised multi-component kit but does not name brands. The single-step workflow was unpack, insert nozzle, and deploy; the improvised workflow required syringe/atomizer assembly before insertion and deployment. Before education, 90-95% could unpack either device, 60-65% assembled the improvised kit, 35% deployed it, and 15% delivered a full dose; after education, 90% or more completed every step. First-use success favored the single-step device (85% versus 20%). The finding concerns simulated first use and training burden, not clinical overdose outcomes or product superiority in all settings.

Literature review and evidence synthesis

This usability trial sits alongside a broader naloxone-access literature focused on program effectiveness rather than device mechanics. A 2025 systematic review and meta-analysis in BMC Public Health examined the effectiveness of naloxone distribution in community settings for reducing opioid overdose deaths (PMID 40133970). A 2021 BMC Public Health scoping umbrella review synthesized evidence on take-home naloxone programs for suspected opioid overdose in community settings (PMID 33771150), the same programmatic context this study feeds into. A 2017 Clinical Toxicology study asked whether heroin overdose patients require observation after receiving naloxone (PMID 27849133), the post-reversal monitoring question that follows successful administration.

How this fits with the broader evidence

• This trial (direct evidence): Device simplicity produced large, significant accuracy and speed advantages before any training; structured education closed the accuracy gap but not the speed gap, showing device design and teaching are complementary, not interchangeable, levers.
• 2025 community-distribution systematic review (PMID 40133970) and 2021 take-home naloxone umbrella review (PMID 33771150): These reviews examined the effectiveness of naloxone distribution programs among people who use drugs; this trial adds the device-usability layer underneath that program-level evidence, access alone is not enough if first-use administration fails.
• 2017 post-reversal observation study (PMID 27849133): Frames the downstream question of what happens after a successful reversal, once this trial's device-usability question has been answered.

ACPE UAN: 0683-0000-26-036-H01-P

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Study source: PMID:42139771