Enrolling by Invitation

NCT Number: NCT06523985

The Feasibility of Using the PulsePoint to Facilitate Overdose Education and Naloxone Distribution

This study is a feasibility trial to assess whether, in a random sample of 180 agencies where PulsePoint is already active, revised procedures (hereinafter PulsePoint-OD) to facilitate opioid overdose and naloxone distribution (OEND) can successfully recruit first responder agencies and layperson responders. For this study, agency refers to a single implementation site where PulsePoint is active and that is bound by the service area or jurisdiction of the first responder agency collaborating with PulsePoint.

The study will test the following hypotheses:

H1: more first responder agencies will be successfully recruited by arm 2 than by arm 1.

H2: more layperson responders will report engaging with OEND programming in arm 2 than in arms 1 or 3 and in arm 1 than in arm 3 [only this hypothesis is covered by the IRB, hypothesis 1 is not human subjects research].

Enrolling by Invitation

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Key information

Conditions

Carrying Naloxone/Narcan on Their Person or in Their Vehicle Being Trained to Respond to an Opioid Overdose

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University Bloomington

Bloomington, Indiana, 47405, United States

About this study

A full, detailed description of the study protocol and preregistered procedures is located in our formal protocol paper (https://doi.org/10.2196/57280) which is also cited at the end of this specific registration.

All specific language throughout this document is derived directly (verbatim) from the protocol paper, which is our controlling, planned preregistration document for this project.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Layperson responders who are part of the PulsePoint system register with a local first responder agency using their smartphone. Anyone who is registered with a PulsePoint agency randomly selected for this project is included. Most layperson responders (eg, those who are not also off-duty first responders themselves) are only alerted to incidents in public spaces. No identifying information is collected from these users except the unique ID of the device.

Treatment and study plan

Push messages (standard)

Behavioral

Push messages will be developed based on best practice recruitment principles in cooperation with an external marketing team and then reviewed and finalized by the study team. Messages will be different each month and sent across 12 months. The monthly time frame was selected based on our need to balance contact with responders and research or expert opinions on push messaging saturation.

Push messages (customized)

Behavioral

These messages are similar to content in the standard push messages but are customized to address common misperceptions about opioid overdose and naloxone.

Primary outcomes

Certification of receiving OEND programming and naloxone carrying

Time frame: 12 months

At baseline, we will calculate the ratio of persons certifying that they are trained (numeric count of N) compared to the total number of push message recipients (T), the ratio of persons certifying that they carry naloxone (numeric count of C) compared to the total number of push message recipients (T), and the ratio of individuals who clicked on the link (O) compared to the total number of push message recipients (T). Separately at 6- and 12-month follow-ups, the numbers of certifications of training and carrying naloxone (N and C, respectively) that were submitted compared to the numbers of push recipients (T) in each period (tracked by D) and the ratio of individuals who clicked on the link (O) each month compared to the number of total push message recipients (T). Our outcome variables are ratios: X = (N / T) for each value of D (0, 1, or 2) and Y = (C / T) for each value of D. The ratio Z = (O / T) is a covariate representing engagement with push messages at each value of D.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

National Institute on Drug Abuse (NIDA)

Registry information

Official study title

The Feasibility of Using the National PulsePoint Cardiopulmonary Resuscitation Responder Network to Facilitate Overdose Education and Naloxone Distribution

Acronym: PP-OD

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Jul 29, 2024
Registry last updated: Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.