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

1600 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of this treatment for opioid overdose?

Research shows that training people, including healthcare professionals and nonmedical personnel, on how to use naloxone (a drug that can reverse opioid overdoses) increases their knowledge and confidence in managing overdoses. This training has been effective in various settings, helping to prevent deaths from opioid overdoses. ^{1 2 3 4 5}

Is naloxone training safe for humans?

Naloxone training programs have been widely implemented to help prevent opioid overdose deaths, and there is no evidence suggesting that these training programs are unsafe for participants. The focus of these programs is on education and skill-building, which are generally considered safe activities. ^{4 5 6 7 8}

How is the Naloxone Training for Opioid Overdose treatment different from other treatments for opioid overdose?

This treatment is unique because it focuses on training individuals, including healthcare professionals and community members, to effectively respond to opioid overdoses using naloxone, a medication that can reverse the effects of an overdose. Unlike other treatments that may focus solely on medication administration, this approach emphasizes education and skill-building to empower more people to act in emergency situations. ^{1 4 9 10 11}

Research Team

Hye Jeong Choi

Principal Investigator

Univeristy of Missouri

Michael Hecht

Principal Investigator

Real Prevention

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 '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]

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]

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]

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]

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]

References

1. Netherlands 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. [2015]

2. Netherlands 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. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Impact of the take ACTION Train-the-Trainer model of opioid overdose education with naloxone distribution- who benefits? [2021]

4. United States pubmed.ncbi.nlm.nih.gov

An Opioid Education Program for Baccalaureate Nursing Students. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Naloxone Training From Nonmedical Personnel: Benefits Before, During, and After Overdose Events. [2021]

6. England 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. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Developing the Opioid Rapid Response System™ for Lay Citizen Response to the Opioid Overdose Crisis: a Randomized Controlled Trial. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the Overdose Education and Naloxone Distribution Program of the Baltimore Student Harm Reduction Coalition. [2022]

9. Netherlands 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. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Implementation of an Opioid Overdose and Naloxone Distribution Training in a Pharmacist Laboratory Course. [2023]

11. Scotland pubmed.ncbi.nlm.nih.gov

A pilot study to compare virtual reality to hybrid simulation for opioid-related overdose and naloxone training. [2020]