Naloxone Training for Opioid Overdose

Overseen By Katrin Ewald

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Missouri-Columbia

Disqualifiers: Non-PulsePoint areas, Under 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to reduce opioid overdose deaths by training citizens to use naloxone, a life-saving drug that reverses overdoses. Participants will use an app to receive alerts about nearby overdoses and learn to respond effectively. The study includes two groups: one receiving online naloxone training and another receiving general opioid information without naloxone specifics until the study concludes. It suits individuals living in PulsePoint communities who speak English and can use a smartphone app. As an unphased trial, this study allows participants to contribute to community health by learning vital skills to save lives.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this training is safe for participants?

Research has shown that naloxone training is safe and easy for participants to manage. One study found that when individuals learned to use naloxone and assisted someone during an overdose, they successfully revived the person 90% of the time. This indicates that the training is effective and participants handle it well.

Another study demonstrated that training improved individuals' ability to recognize and respond to overdoses over time. No evidence suggests harm from learning how to use naloxone, as the training resembles other educational programs.

Overall, these findings suggest that naloxone training, such as that included in the ORRS project, is safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to tackle opioid overdoses through innovative training methods. The Opioid Rapid Response System (ORRS) training offers a unique approach by delivering online Naloxone training, which could make life-saving education more accessible and convenient. Unlike standard treatments that focus solely on the medication itself, this trial emphasizes empowering people with the knowledge to act quickly in emergencies, potentially increasing the effectiveness of overdose response efforts. By comparing ORRS training with non-active training, researchers hope to find out how critical comprehensive education is in managing opioid overdoses.

What evidence suggests that the Opioid Rapid Response System (ORRS) training is effective for opioid overdose response?

Research has shown that teaching people to use naloxone can greatly reduce deaths from opioid overdoses. One study found that 90% of overdose victims were successfully revived by individuals who had received community naloxone training. This indicates that naloxone training can significantly increase the chances of saving lives during an overdose. In this trial, participants in the Opioid Rapid Response System (ORRS) training group will receive online naloxone training, aiming to expand these benefits by connecting trained individuals to overdose situations through technology. This approach could help people get assistance faster, especially in areas where emergency services are slow. Meanwhile, the waitlist group will initially receive non-active opioid overdose response training, focusing on opioid prevalence and addiction without naloxone management. Overall, past evidence supports the idea that naloxone training is a powerful tool in fighting opioid overdoses. ^{1 2 4 6 7}

Who Is on the Research Team?

Hye Jeong Choi

Principal Investigator

Univeristy of Missouri

Michael Hecht

Principal Investigator

Real Prevention

Are You a Good Fit for This Trial?

This trial is for adults over 18 who live in communities using the PulsePoint app, speak English fluently, and can download and use apps on a smartphone. It's not suitable for those who don't meet these criteria.

Inclusion Criteria

I live in a PulsePoint community.

I can speak and understand English fluently.

I can use a smartphone and download apps.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Development

Refine and complete the development of the Opioid Rapid Response System (ORRS)

Not specified

Training

Participants receive online Naloxone training or non-active opioid overdose response training

Up to 1 month

Follow-up

Participants are monitored for their intent to intervene, self-efficacy, response efficacy, knowledge, and concerns related to opioid overdose management

Up to 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Non-active opioid overdose response training
• Opioid Rapid Response System (ORRS) training

Trial Overview The study tests an Opioid Rapid Response System (ORRS) training against standard non-active opioid overdose response training to see if it improves naloxone administration during overdoses using the PulsePoint health app.

How Is the Trial Designed?

Group I: ORRS training group Experimental Treatment 1 Intervention

Online Naloxone training

Group II: Waitlist group Placebo Group 1 Intervention

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.

Non-active opioid overdose response training is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Naloxone for:

• Reversal of opioid overdose

Approved in European Union as Naloxone for:

• Reversal of opioid overdose

Approved in Canada as Naloxone for:

• Reversal of opioid overdose

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

Published Research Related to This Trial

The Baltimore Student Harm Reduction Coalition (BSHRC) successfully distributed 250 free naloxone kits during an 8-month pilot program, demonstrating the feasibility of third-party naloxone prescriptions under new Maryland laws.

Training participants reported increased confidence in their ability to prevent and respond to overdoses, with this self-efficacy lasting for up to 12 months after the training, highlighting the program's potential for long-term impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Overdose Education and Naloxone Distribution Program of the Baltimore Student Harm Reduction Coalition. Lewis, DA., Park, JN., Vail, L., et al.[2022]

Training healthcare professionals in managing opioid overdoses and administering naloxone significantly improved their knowledge and confidence, with scores increasing from an average of 18.3 to 21.2 out of 26 after training.

While the 'cascade method' of training was somewhat effective, challenges such as clinician time constraints and resource availability hindered broader implementation, highlighting the need for policy changes and enhanced educational programs in drug services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of training for healthcare professionals on how to manage an opioid overdose with naloxone: effective, but dissemination is challenging. Mayet, S., Manning, V., Williams, A., et al.[2015]

In a study of 1280 participants who recently used opioids or received opioid agonist treatment, 7% reported a recent non-fatal opioid overdose, highlighting the ongoing risk of overdose in this population.

Despite the association of benzodiazepine and hazardous alcohol use with increased risk of overdose, only 17% of participants had access to naloxone and 14% had received training, indicating a significant gap in overdose prevention resources that needs to be addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-fatal opioid overdose, naloxone access, and naloxone training among people who recently used opioids or received opioid agonist treatment in Australia: The ETHOS Engage study. Conway, A., Valerio, H., Peacock, A., et al.[2021]

A brief 15-minute naloxone training program significantly improved overdose knowledge among 448 opioid users, leading to effective use of naloxone in 97.7% of reported overdose reversals.

Training in dyads, where one partner is also an opioid user, may enhance the effectiveness of naloxone training and improve follow-up reporting on its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Naloxone Training From Nonmedical Personnel: Benefits Before, During, and After Overdose Events. Chichester, K., Sisson, ML., Schiavon, SP., et al.[2021]

The Opioid Rapid Response System (ORRS) effectively trained lay citizens to administer naloxone, showing significant improvements in knowledge of overdose signs and management, as well as increased self-efficacy in responding to overdoses, based on a randomized trial with 220 participants.

Recruitment strategies that used communal appeals were more successful than personal appeals, indicating that community-focused messaging can enhance participation in naloxone training programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing the Opioid Rapid Response System™ for Lay Citizen Response to the Opioid Overdose Crisis: a Randomized Controlled Trial. Hecht, ML., Jayawardene, W., Henderson, C., et al.[2023]

Training baccalaureate nursing students on opioids and naloxone significantly improved their knowledge, skills, and confidence in responding to opioid overdoses, as shown by data from 284 students.

The positive impact of the training was sustained over time, with slight enhancements in knowledge and skills observed one week after the training, indicating its effectiveness across different semesters of the nursing program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Opioid Education Program for Baccalaureate Nursing Students. Hines, CB., Cody, SL., Eyer, JC., et al.[2021]

In a survey of 458 people who inject drugs in San Francisco, 62.9% reported receiving overdose response training, and 68.8% owned a naloxone kit, indicating a significant level of preparedness to respond to opioid overdoses.

However, there are disparities in training access, as non-white individuals were less likely to receive overdose response training compared to white individuals, highlighting the need for targeted outreach to improve naloxone use among diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence and disparities in opioid overdose response training among people who inject drugs, San Francisco: Naloxone training among injectors in San Francisco. Kim, K., Oh, H., Miller, D., et al.[2021]

The opioid overdose response program (ORP) effectively increased the knowledge and confidence of 56 third-year pharmacy students in providing overdose response and dispensing naloxone, as evidenced by significant improvements in pre- and post-assessment scores.

Utilizing the 5-E learning cycle for the training structure led to positive student feedback, indicating that active-learning activities were perceived as very effective in enhancing their understanding and attitudes towards opioid overdose education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of an Opioid Overdose and Naloxone Distribution Training in a Pharmacist Laboratory Course. Kwon, M., Moody, AE., Thigpen, J., et al.[2023]

The 'Danish Save Lives' program, which trained 552 participants including police officers, opioid users, and social workers, demonstrated that overdose education and naloxone distribution can effectively reduce opioid overdose deaths, with 37 participants intervening in 45 overdose events.

Participants who used opioids were significantly more likely to intervene in overdose situations, highlighting the importance of targeting opioid users in prevention programs for greater effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One opioid user saving another: the first study of an opioid overdose-reversal and naloxone distribution program addressing hard-to-reach drug scenes in Denmark. Thylstrup, B., Hesse, M., Jørgensen, M., et al.[2020]

A study involving 50 senior nursing students found that training using virtual reality simulation was as effective as traditional hybrid simulation in teaching how to recognize and respond to opioid-related overdoses and administer naloxone.

Both training methods resulted in similar knowledge retention and attitudes towards intervening in overdose situations, suggesting that virtual reality can be a viable alternative for naloxone training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study to compare virtual reality to hybrid simulation for opioid-related overdose and naloxone training. Giordano, NA., Whitney, CE., Axson, SA., et al.[2020]

The train-the-trainer model for overdose education and naloxone distribution significantly increased participants' knowledge and confidence in teaching others, especially among those with no prior experience, as shown by a statistically significant improvement (p < .001).

Six months after training, participants successfully trained 243 new individuals, highlighting the effectiveness of this model in expanding the reach of naloxone education to combat the opioid overdose epidemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of the take ACTION Train-the-Trainer model of opioid overdose education with naloxone distribution- who benefits? Dahlem, CH., Scalera, M., Chen, B., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06238128?cond=%22Opiate%20Overdose%22&viewType=Table&rank=9

Opioid Rapid Response System: Naloxone Training in ... 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 ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2772724625000241

Reported outcomes from a community naloxone training ... Individuals who helped with an overdose were able to revive the person in 172 (90 %) of the reported overdoses. Our data suggests that participants in these ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9427328/

Development of Opioid Rapid Response System: Protocol for ... This study aimed to examine the feasibility of the Opioid Rapid Response System (ORRS) that recruits, trains, and links citizen responders to overdose events ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8489614/

The Effect of Overdose Education and Naloxone Distribution OEND training may improve OEND participant's ability to respond to overdose; however, it is unclear which educational components are most effective. Results ...

5. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-025-22210-8

Effectiveness of naloxone distribution in community settings to ... The paper demonstrates that in the face of increasing overdose deaths over time, survival after naloxone administration has been sustained.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8450721/

Multi-informant Implementation and Intervention Outcomes ... This study evaluated 16 OEND trainings conducted at different Opioid Overdose Prevention Programs in New York City.

7. cdc.gov cdc.gov/mmwr/volumes/73/wr/mm7305a4.htm

New York, March 2022–August 2023 | MMWR This study is the first to provide real-world data comparing postnaloxone signs and symptoms and survival among persons administered 8-mg and 4- ...