Carrying Naloxone/Narcan on Their Person or in Their VehiclePP-ODNCT06523985
The Feasibility of Using the PulsePoint to Facilitate Overdose Education and Naloxone Distribution
A study testing Push messages (standard) and Push messages (customized) in people with Carrying Naloxone/Narcan on Their Person or in Their Vehicle and Being Trained to Respond to an Opioid Overdose, run by Indiana University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carrying Naloxone/Narcan on Their Person or in Their Vehicle, Being Trained to Respond to an Opioid Overdose
- What is being tested?
- Push messages (standard) and Push messages (customized)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2024to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Bloomington
Bloomington, Indiana, 47405
About this study
Official title: The Feasibility of Using the National PulsePoint Cardiopulmonary Resuscitation Responder Network 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:
Read more
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].
Read the detailed description
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.
- Conditions
- Carrying Naloxone/Narcan on Their Person or in Their Vehicle, Being Trained to Respond to an Opioid Overdose
- Being tested
- Push messages (standard), Push messages (customized)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Push messages (standard)Behavioural
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)Behavioural
These messages are similar to content in the standard push messages but are customized to address common misperceptions about opioid overdose and naloxone.
| Study group | Role | What they receive |
|---|---|---|
| Standard layperson messaging (Arm 1) | Active comparator | Users randomized to arm 1 will receive standard monthly recruitment push messages. These push messages will differ from the certification messages because they will contain language intended to foster engagement with OEND services (eg, to get trained and carry naloxone) alongside the link to a landing page. Receives: Behavioral: Push messages (standard) |
| Customized layperson messaging (Arm 2) | Experimental | Arm 2 will follow the same procedures that are described for arm 1 but will use separate messaging. Specifically, the push messages and landing page will contain additional, brief messages that specifically provide factual information that counteracts misperceptions about overdose and naloxone. Receives: Behavioral: Push messages (customized) |
| Control arm (Arm 3) | No intervention | Arm 3 functions as the control arm and will not receive any monthly recruitment messaging or encouragement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Certification of receiving OEND programming and naloxone carrying
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start7 Aug 2024
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carrying Naloxone/Narcan on Their Person or in Their VehicleStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Jon Agley, Indiana University
- Investigators
- Jon Agley, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523985
- Sponsor's protocol ID
- R34DA058162
- Other IDs
- R34DA058162
- Acronym
- PP-OD
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2024
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified raw data will be provided alongside publications using those data.
Publications
Agley J, Henderson C, Nair M, Seo DC, Parker M, Golzarri-Arroyo L, Dickinson S, Tidd D. Recruiting a National Sample of First Response Agencies to Participate in an Overdose Prevention Research Project: Randomized Controlled Trial and Feasibility Study. JMIR Form Res. 2026 Apr 2;10:e81743. doi: 10.2196/81743.
PubMed 41925721Agley J, Henderson C, Seo DC, Parker M, Golzarri-Arroyo L, Dickinson S, Tidd D. The Feasibility of Using the National PulsePoint Cardiopulmonary Resuscitation Responder Network to Facilitate Overdose Education and Naloxone Distribution: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Mar 29;13:e57280. doi: 10.2196/57280.
PubMed 38551636
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Using the National PulsePoint Cardiopulmonary Resuscitation Responder Network to Facilitate Overdose Education and Naloxone Distribution
- ClinicalTrials.gov ID
- NCT06523985
- Acronym / sponsor ID
- PP-OD / R34DA058162
- Conditions
- Carrying Naloxone/Narcan on Their Person or in Their Vehicle, Being Trained to Respond to an Opioid Overdose
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 7 Aug 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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].
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard layperson messaging (Arm 1) | Active comparator | Behavioral: Push messages (standard)Users randomized to arm 1 will receive standard monthly recruitment push messages. These push messages will differ from the certification messages because they will contain language intended to foster engagement with OEND services (eg, to get trained and carry naloxone) alongside the link to a landing page. |
| Customized layperson messaging (Arm 2) | Experimental | Behavioral: Push messages (customized)Arm 2 will follow the same procedures that are described for arm 1 but will use separate messaging. Specifically, the push messages and landing page will contain additional, brief messages that specifically provide factual information that counteracts misperceptions about overdose and naloxone. |
| Control arm (Arm 3) | No intervention | –Arm 3 functions as the control arm and will not receive any monthly recruitment messaging or encouragement. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Push messages (standard)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. | Behavioural | Standard layperson messaging (Arm 1) |
| Push messages (customized)These messages are similar to content in the standard push messages but are customized to address common misperceptions about opioid overdose and naloxone. | Behavioural | Customized layperson messaging (Arm 2) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Background: PubMed 41925721Agley J, Henderson C, Nair M, Seo DC, Parker M, Golzarri-Arroyo L, Dickinson S, Tidd D. Recruiting a National Sample of First Response Agencies to Participate in an Overdose Prevention Research Project: Randomized Controlled Trial and Feasibility Study. JMIR Form Res. 2026 Apr 2;10:e81743. doi: 10.2196/81743.
- Background: PubMed 38551636Agley J, Henderson C, Seo DC, Parker M, Golzarri-Arroyo L, Dickinson S, Tidd D. The Feasibility of Using the National PulsePoint Cardiopulmonary Resuscitation Responder Network to Facilitate Overdose Education and Naloxone Distribution: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Mar 29;13:e57280. doi: 10.2196/57280.
- Open Science Framework PreregistrationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All de-identified raw data will be provided alongside publications using those data.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon Agley principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Push messages (standard) and Push messages (customized) in people with Carrying Naloxone/Narcan on Their Person or in Their Vehicle and Being Trained to Respond to an Opioid Overdose, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Certification of receiving OEND programming and naloxone carrying (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06523985, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.