ClinicalTrials.gg
CompletedNCT06238128Updated Aug 19, 2026Results posted

Opioid Rapid Response System: Naloxone Training in Communities

An interventional study of Opioid Rapid Resonse System (ORRS) training and Non-active opioid overdose response training in Opioid Overdose, sponsored by University of Missouri-Columbia. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by University of Missouri-Columbia · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
773
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study summary

The pervasive impact of the opioid epidemic has touched all layers of society for the past two decades, resulting in over 115 deaths daily and imposing annual costs of $78.5 billion. Responding swiftly to overdoses, akin to various medical emergencies, poses a significant challenge, particularly in geographically dispersed rural areas and densely populated urban settings. Effectively delivering the life-saving drug naloxone, which counteracts the effects of overdoses, necessitates a well-coordinated and cost-efficient response system.

Simply opting for widespread distribution of naloxone, even with citizen involvement, proves to be a financially burdensome approach when compared to more targeted strategies. Moreover, obstacles such as limited access, inadequate or unavailable naloxone training, and delayed response times from emergency responders compound the problem. Addressing these issues, the proposed Opioid Rapid Response System (ORRS) project seeks to advance prevention science by adopting an innovative approach that incorporates technology and contemporary communication theory.

The primary objective of the ORRS project is to mitigate opioid overdose deaths by enlisting and training citizens to administer naloxone in response to such events. Leveraging the PulsePoint health app, which connects citizens to cardiac events, the ORRS project will extend its capabilities to respond to overdose incidents. This initiative involves comprehensive development of ORRS, followed by a randomized clinical trial on a national scale to assess its effectiveness. The study aims to contribute to both prevention and implementation science by identifying optimal recruitment strategies and testing a model of online training. In pursuit of these objectives, the study is guided by the following Specific Aims:

SA 1: Refine and complete the development of ORRS. SA 2: Conduct a randomized clinical trial to evaluate the effectiveness of the intervention. SA 3: Prepare ORRS for dissemination.

02

Conditions studied

  • Opioid Overdose

Browse trials for

Keywords

  • naloxone training
  • Community-engagement
03

In context

Opiate Overdose

70 studies on the registry are indexed under Opiate Overdose; 11 are open to participants now.

This study's enrollment of 773 is above the median of 184 across 48 interventional studies indexed under Opiate Overdose.

Browse Opiate Overdose studies →

Lead sponsor

University of Missouri-Columbia is the lead sponsor of 365 studies on the registry; 69 are open to participants now.

Of its 43 completed or terminated interventional studies of FDA-regulated products, 29 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Citizens who live in participating PulsePoint communities
  • Must to be 18 and older
  • Must be fluent in English
  • Must have access to the mobile data and able to download and use apps in a smartphone

Exclusion criteria

Exclusion Criteria:

  • Citizens who do not live in participating PulsePoint communities
  • Under 18-year-old
  • Citizens who are not fluent in English
  • Citizens who do not have access to mobile data and unable to download and use apps in a smartphone.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
773 participants (actual)

Study arms

  • Experimental
    ORRS training group

    Online Naloxone training

    Behavioral: Opioid Rapid Resonse System (ORRS) training

  • Sham comparator
    Waitlist group

    Participants will receive non-active opioid overdose response training. Investigators will provide online training about opioid prevalence in US, opioid mechanism, side effect, and addiction. However, Investigators do not provide any knowledge about opioid overdose management and naloxone in this training. Once the project is completed, participants will receive online Naloxone training.

    Behavioral: Non-active opioid overdose response training

Interventions

  • BehavioralOpioid Rapid Resonse System (ORRS) training

    ORRS is on online system to train citizen responders to administer NARCAN to save the lives of opioid overdose victims. It capitalizes on the innovative PulsePoint technology to connect responders to overdose events. PulsePoint is an app that connects 911 requesting assistance for cardiac arrests to responders with Cardiopulmonary Resuscitation (CPR) training. ORRS allows us to partner with PulsePoint users to expand its reach to opioid overdoses, which share the need for a quick response that emergency responders are often unable to provide. ORRS has the advantage of expanding the population of responders with NARCAN, rescue breathing, and CPR training that can be connected to overdose events, increasing the likelihood of saving overdose victims' lives through a quick, efficient response. ORRS is delivered through an interactive, digital platform containing sequential, multi-media modules.

  • BehavioralNon-active opioid overdose response training

    Investigators will provide online training about opioid prevalence in US, opioid mechanism, side effect, and addiction. However, Investigators do not provide any knowledge about opioid overdose management and naloxone in this training. Once the project is completed, participants will receive online Naloxone training.

06

What researchers measure

Primary outcomes

  1. Knowledge of Overdose Sign

    Investigators will use a subset of Opioid Overdose Knowledge Scale (OOKS) to measure through a forced choice scale with each choice coded as correct (=1) or incorrect (=0). Higher score indicated greater knowledge of overdose sign.

    Time frame: up to 2 weeks

  2. Knowledge of Overdose Management

    Investigators will use a subset of Opioid Overdose Knowledge Scale (OOKS) to measure through a forced choice scale with each choice coded as correct (=1) or incorrect (=0). Higher score indicated greater knowledge of overdose management.

    Time frame: up to 2 weeks

  3. Self-Efficacy Toward Intervening Opioid Overdose

    Investigators will modify self-efficacy scale developed and theorized by Bandura (2005). Response options are from 0 (no confident) to 100 (highly confident). Higher score indicates greater self-efficacy

    Time frame: up to 2 weeks

  4. Response Efficacy About Intervening Opioid Overdose

    Investigators will develop and measure how participants perceive the effectiveness of activities to intervene opioid overdose events in communities. Response options are from 0 (not effective) to 100 (highly effective). Higher score indicate greater response efficacy.

    Time frame: up to 2 weeks

  5. Concerns Related to Overdose Management

    Investigators will use a subset of Opioid Overdose Attitude Scale (OOAS) with 5 point scale (1: strongly disagree \~5: strongly agree). Higher score indicates the greater concerns.

    Time frame: up to 2 weeks

  6. Intent to Intervene Opioid Overdose Events in Communities

    Investigators will use behavioral intention scale developed by in the opioid training literature (Hecht et al., 2023) to measure intent to intervene opioid overdose events in communities (e.g., administering Narcan). Response options are from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicates grater intention to intervene opioid overdose events in communities.

    Time frame: up to 2 weeks

  7. The Number of Days Per Week, on Average, to Carry Narcan

    Single item: how many days per week, on average, participants carry Narcn

    Time frame: Up to 6 months

  8. Number of Participants to Response to Overdose Events From PulsePoint App.

    Single item: whether participant response to overdose events from PulsePoint notifications/alerts

    Time frame: Up to 6 months

  9. Number of Participants to Administer Narcan

    Single item: Whether participant administer Narcan to respond opioid overdose events in communities.

    Time frame: Up to 6 months

07

Results

Posted Jul 7, 2026
Limitations and caveats
Generalizability may be limited because participants were recruited online from selected regions, which may have introduced coverage and self-selection bias. Substantial loss to follow-up and missing outcome data, including differential attrition across study conditions, may have biased estimated intervention effects. In addition, intranasal naloxone became available over the counter in the United States while the trial was underway, which may have changed the composition of enrolled participant

Participant flow

Participant flow — Overall Study
MilestoneBehavioral: Opioid Rapid Resonse System (ORRS) TrainingBehavioral: Non-active Opioid Overdose Response Training
Started383390
Immediate posttest complete312338
1 month follow up complete144156
3 month follow up complete121146
Completed107118
Not completed276272

Outcome measures

PrimaryKnowledge of Overdose Sign

Investigators will use a subset of Opioid Overdose Knowledge Scale (OOKS) to measure through a forced choice scale with each choice coded as correct (=1) or incorrect (=0). Higher score indicated greater knowledge of overdose sign.

Time frame:
up to 2 weeks
Reported as:
Mean · scores
Knowledge of Overdose Sign
scoresBehavioral: Opioid Rapid Resonse System (ORRS) TrainingBehavioral: Non-active Opioid Overdose Response Training
Knowledge of Overdose Sign0.82 ± 0.170.78 ± 0.16
Statistical analysis
  • Behavioral: Opioid Rapid Resonse System (ORRS) Training vs Behavioral: Non-active Opioid Overdose Response Training · Regression, Linear · p = <.001P-value is from the prespecified regression model comparing ORRS with control. Missing outcome or covariate data were handled using multiple imputatio
PrimaryKnowledge of Overdose Management

Investigators will use a subset of Opioid Overdose Knowledge Scale (OOKS) to measure through a forced choice scale with each choice coded as correct (=1) or incorrect (=0). Higher score indicated greater knowledge of overdose management.

Time frame:
up to 2 weeks
Reported as:
Mean · scores
Knowledge of Overdose Management
scoresBehavioral: Opioid Rapid Resonse System (ORRS) TrainingBehavioral: Non-active Opioid Overdose Response Training
Knowledge of Overdose Management0.83 ± 0.150.66 ± 0.21
Statistical analysis
  • Behavioral: Opioid Rapid Resonse System (ORRS) Training vs Behavioral: Non-active Opioid Overdose Response Training · Regression, Linear · p = <.001P-value is from the prespecified regression model comparing ORRS with control. Missing outcome or covariate data were handled using multiple imputatio
PrimarySelf-Efficacy Toward Intervening Opioid Overdose

Investigators will modify self-efficacy scale developed and theorized by Bandura (2005). Response options are from 0 (no confident) to 100 (highly confident). Higher score indicates greater self-efficacy

Time frame:
up to 2 weeks
Reported as:
Mean · scores
Self-Efficacy Toward Intervening Opioid Overdose
scoresBehavioral: Opioid Rapid Resonse System (ORRS) TrainingBehavioral: Non-active Opioid Overdose Response Training
Self-Efficacy Toward Intervening Opioid Overdose80.12 ± 18.8962.22 ± 28.52
Statistical analysis
  • Behavioral: Opioid Rapid Resonse System (ORRS) Training vs Behavioral: Non-active Opioid Overdose Response Training · Regression, Linear · p = <.001 (P-value is from the prespecified regression model comparing ORRS with control. Missing outcome or covariate data were handled using multiple imputation.)
PrimaryResponse Efficacy About Intervening Opioid Overdose

Investigators will develop and measure how participants perceive the effectiveness of activities to intervene opioid overdose events in communities. Response options are from 0 (not effective) to 100 (highly effective). Higher score indicate greater response efficacy.

Time frame:
up to 2 weeks
Reported as:
Mean · scores
Response Efficacy About Intervening Opioid Overdose
scoresBehavioral: Opioid Rapid Resonse System (ORRS) TrainingBehavioral: Non-active Opioid Overdose Response Training
Response Efficacy About Intervening Opioid Overdose85.66 ± 17.9776.25 ± 21.53
Statistical analysis
  • Behavioral: Opioid Rapid Resonse System (ORRS) Training vs Behavioral: Non-active Opioid Overdose Response Training · Regression, Linear · p = <.001P-value is from the prespecified regression model comparing ORRS with control. Missing outcome or covariate data were handled using multiple imputatio
PrimaryConcerns Related to Overdose Management

Investigators will use a subset of Opioid Overdose Attitude Scale (OOAS) with 5 point scale (1: strongly disagree \~5: strongly agree). Higher score indicates the greater concerns.

Time frame:
up to 2 weeks
Reported as:
Mean · scores
Concerns Related to Overdose Management
scoresBehavioral: Opioid Rapid Resonse System (ORRS) TrainingBehavioral: Non-active Opioid Overdose Response Training
Concerns Related to Overdose Management2.33 ± 1.043.04 ± 1.13
Statistical analysis
  • Behavioral: Opioid Rapid Resonse System (ORRS) Training vs Behavioral: Non-active Opioid Overdose Response Training · Regression, Linear · p = <.001P-value is from the prespecified regression model comparing ORRS with control. Missing outcome or covariate data were handled using multiple imputatio
PrimaryIntent to Intervene Opioid Overdose Events in Communities

Investigators will use behavioral intention scale developed by in the opioid training literature (Hecht et al., 2023) to measure intent to intervene opioid overdose events in communities (e.g., administering Narcan). Response options are from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicates grater intention to intervene opioid overdose events in communities.

Time frame:
up to 2 weeks
Reported as:
Mean · scores
Intent to Intervene Opioid Overdose Events in Communities
scoresBehavioral: Opioid Rapid Resonse System (ORRS) TrainingBehavioral: Non-active Opioid Overdose Response Training
Intent to Intervene Opioid Overdose Events in Communities4.31 ± 0.874.09 ± 0.94
Statistical analysis
  • Behavioral: Opioid Rapid Resonse System (ORRS) Training vs Behavioral: Non-active Opioid Overdose Response Training · Regression, Linear · p = <.001P-value is from the prespecified regression model comparing ORRS with control. Missing outcome or covariate data were handled using multiple imputatio
PrimaryThe Number of Days Per Week, on Average, to Carry Narcan

Single item: how many days per week, on average, participants carry Narcn

Time frame:
Up to 6 months
Reported as:
Mean · days per week
The Number of Days Per Week, on Average, to Carry Narcan
days per weekBehavioral: Opioid Rapid Resonse System (ORRS) TrainingBehavioral: Non-active Opioid Overdose Response Training
1 month3.87 ± 3.17—
3 month4.25 ± 2.99—
6 month4.00 ± 3.05—
Statistical analysis
  • Behavioral: Opioid Rapid Resonse System (ORRS) Training · Regression, Linear · p = <.001Missing outcome or covariate data were handled using multiple imputation.
PrimaryNumber of Participants to Response to Overdose Events From PulsePoint App.

Single item: whether participant response to overdose events from PulsePoint notifications/alerts

Time frame:
Up to 6 months
Reported as:
Count of participants · Participants
Number of Participants to Response to Overdose Events From PulsePoint App.
ParticipantsBehavioral: Opioid Rapid Resonse System (ORRS) TrainingBehavioral: Non-active Opioid Overdose Response Training
1 month2412
3 month3420
6 month2719
Statistical analysis
  • Behavioral: Opioid Rapid Resonse System (ORRS) Training vs Behavioral: Non-active Opioid Overdose Response Training · Regression, Logistic · p = 0.10 (P-value is for the ORRS-versus-control comparison at the 1-month follow-up from the repeated-measures logistic regression model.)P-value is from the prespecified regression model comparing ORRS with control. Missing outcome or covariate data were handled using multiple imputatio
  • Behavioral: Opioid Rapid Resonse System (ORRS) Training vs Behavioral: Non-active Opioid Overdose Response Training · Regression, Logistic · p = 0.02 (P-value is for the ORRS-versus-control comparison at the 3-month follow-up from the repeated-measures logistic regression model. Missing outcome or covariate data were handled using multiple imputation.)
  • Behavioral: Opioid Rapid Resonse System (ORRS) Training vs Behavioral: Non-active Opioid Overdose Response Training · Regression, Logistic · p = 0.06 (P-value is for the ORRS-versus-control comparison at the 6-month follow-up from the repeated-measures logistic regression model. Missing outcome or covariate data were handled using multiple imputation.)
PrimaryNumber of Participants to Administer Narcan

Single item: Whether participant administer Narcan to respond opioid overdose events in communities.

Time frame:
Up to 6 months
Reported as:
Count of participants · Participants
Number of Participants to Administer Narcan
ParticipantsBehavioral: Opioid Rapid Resonse System (ORRS) TrainingBehavioral: Non-active Opioid Overdose Response Training
1 month2917
3 month3321
6 month3315
Statistical analysis
  • Behavioral: Opioid Rapid Resonse System (ORRS) Training vs Behavioral: Non-active Opioid Overdose Response Training · Regression, Logistic · p = .10 (P-value is for the ORRS-versus-control comparison at the 1-month follow-up from the repeated-measures logistic regression model. Missing outcome or covariate data were handled using multiple imputation.)
  • Behavioral: Opioid Rapid Resonse System (ORRS) Training vs Behavioral: Non-active Opioid Overdose Response Training · Regression, Logistic · p = 0.22 (P-value is for the ORRS-versus-control comparison at the 3-month follow-up from the repeated-measures logistic regression model. Missing outcome or covariate data were handled using multiple imputation.)
  • Behavioral: Opioid Rapid Resonse System (ORRS) Training vs Behavioral: Non-active Opioid Overdose Response Training · Regression, Logistic · p = 0.09 (P-value is for the ORRS-versus-control comparison at the 6-month follow-up from the repeated-measures logistic regression model. Missing outcome or covariate data were handled using multiple imputation.)

Adverse events

Collected over From enrollment until end of follow-up, up to 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Behavioral: Opioid Rapid Resonse System (ORRS) Training0/383 (0%)0/383 (0%)0/383 (0%)
Behavioral: Non-active Opioid Overdose Response Training0/390 (0%)0/390 (0%)0/390 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Behavioral: Opioid Rapid Resonse System (ORRS) TrainingBehavioral: Non-active Opioid Overdose Response TrainingTotal
Mean36.64 ± 12.1537.86 ± 12.7637.25 ± 12.47
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Behavioral: Opioid Rapid Resonse System (ORRS) TrainingBehavioral: Non-active Opioid Overdose Response TrainingTotal
Man174175349
Woman196205401
Others131023
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Behavioral: Opioid Rapid Resonse System (ORRS) TrainingBehavioral: Non-active Opioid Overdose Response TrainingTotal
White/Caucasian American238243481
Black/African American8764151
Asian or Pacific Islander72027
American Indian/Alaska Native121729
Bi-Racial or Multi-Racial253156
Others/Not reported141529
Knowledge of overdose sign
Knowledge of overdose sign(Score on a 0 to 1 scale)Behavioral: Opioid Rapid Resonse System (ORRS) TrainingBehavioral: Non-active Opioid Overdose Response TrainingTotal
Mean0.77 ± 0.180.78 ± 0.180.77 ± 0.18
Knowledge of overdose management
Knowledge of overdose management(Score on a 0 to 1 scale)Behavioral: Opioid Rapid Resonse System (ORRS) TrainingBehavioral: Non-active Opioid Overdose Response TrainingTotal
Mean0.57 ± 0.250.56 ± 0.260.57 ± 0.25
Self-Efficacy toward intervening opioid overdose
Self-Efficacy toward intervening opioid overdose(Score on a 0 to 100 scale)Behavioral: Opioid Rapid Resonse System (ORRS) TrainingBehavioral: Non-active Opioid Overdose Response TrainingTotal
Mean50.60 ± 28.8851.29 ± 27.9550.95 ± 28.40
Response efficacy about intervening opioid overdose
Response efficacy about intervening opioid overdose(Score on a 0 to 100 scale)Behavioral: Opioid Rapid Resonse System (ORRS) TrainingBehavioral: Non-active Opioid Overdose Response TrainingTotal
Mean70.31 ± 23.5370.30 ± 23.6270.31 ± 23.56
Concerns related to overdose management
Concerns related to overdose management(Score on a 1 to 5 scale)Behavioral: Opioid Rapid Resonse System (ORRS) TrainingBehavioral: Non-active Opioid Overdose Response TrainingTotal
Mean3.63 ± 1.003.55 ± 1.043.59 ± 1.02

1 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Ewald & Wasserman Research Consultants, LLC
    San Francisco, California 94104, United States
09

References and documents

Publications

  • Carr DL, Hecht ML, Shiota MN, Zalake M, Krieger J, Choi HJ. Protocol for a national randomized controlled trial evaluating the Opioid Rapid Response System for overdose death prevention. Contemp Clin Trials. 2025 Mar;150:107835. doi: 10.1016/j.cct.2025.107835. Epub 2025 Feb 3. PubMed 39909302 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — Because this study is funded as a part of NIH HEAL initiative, investigators will follow the HEAL data sharing policy.

Supporting information: Study protocol, Informed consent form

Time frame: When project is completed.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2024 to primary completion in Dec 2025, 19 months.

Results were first posted in Jul 2026, 6 months after primary completion.

Of 28 interventional studies with no phase under Opiate Overdose, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 41. This study's 19 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 21, 2023
First posted
Feb 2, 2024
StartActual
May 24, 2024
Primary completionActual
Dec 29, 2025
CompletionActual
Dec 29, 2025
Results first posted
Jul 7, 2026
Last update
Aug 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06238128
Responsible party
Hye Jeong Choi (Associate Professor, University of Missouri-Columbia) — Principal investigator
First posted
Feb 2, 2024
Start date
May 24, 2024
Primary completion
Dec 29, 2025
Completion
Dec 29, 2025
Results posted
Jul 7, 2026
Last update
Aug 19, 2026

Study contacts

Hye Jeong Choi
principal investigator · Univeristy of Missouri
Michael Hecht
principal investigator · Real Prevention

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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