Overdose Education for Opioid Overdose

Recruiting at 1 trial location

Overseen By Jimmy Choi, PsyD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hartford Hospital

Disqualifiers: Non-English speakers, Police custody, others

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

Compensation: Varies

Number of Visits: 2

84 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on education about naloxone for opioid overdose prevention.

What data supports the effectiveness of the treatment Enhanced Overdose Education (EOE) and related drugs for opioid overdose?

Research shows that overdose education and naloxone distribution are effective in reducing overdose deaths. Studies highlight the importance of education in improving patient knowledge and response to opioid overdoses, and naloxone, a key component of the treatment, has been successfully used to reverse overdoses in emergency situations. ^{1 2 3 4 5}

Is naloxone safe for use in humans?

Naloxone has a long history of safe use in treating opioid overdoses, with serious adverse reactions being rare. It is generally safe when used by healthcare professionals, and new delivery methods are being developed for use by non-professionals in emergencies. ^{2 6 7 8 9}

How is Enhanced Overdose Education (EOE) different from other opioid overdose treatments?

Enhanced Overdose Education (EOE) is unique because it focuses on providing more comprehensive and personalized education about opioid overdose risks and prevention, compared to standard education programs that primarily distribute naloxone (a medication that reverses opioid overdoses). EOE aims to improve understanding and readiness to respond to overdoses, potentially making it more effective in preventing fatalities. ^{10 11 12 13 14}

What is the purpose of this trial?

While there is a lifesaving medication called naloxone that can reverse the deadly effects of opioid overdose, patients often fail to fill the prescription at the pharmacy when it is prescribed. This is particularly concerning and true in those at the highest risk of death-those who end up in the emergency department for opioid overdose. The goal of this study is to compare the impact of different overdose education on naloxone prescription fill rates in opioid users being discharged from our hospital emergency department. You will receive either (a) written education about naloxone through their MyChart account, or (b) a concise one-page handout and 4-minute video clip reviewed with the participant and a support individual (family/friend) prior to discharge.

Research Team

Jonathan C Allen, MD

Principal Investigator

Hartford HealthCare

Eligibility Criteria

This trial is for patients leaving Hartford Hospital's Emergency Department with a prescription for naloxone after opioid intoxication or poisoning, including those who use illicit or prescription opioids, or have conditions related to opioid injection.

Inclusion Criteria

I am being discharged from the hospital with a naloxone kit after an opioid-related incident.

Exclusion Criteria

I have been trained on using a naloxone kit or am allergic to naloxone.

Patient is in police custody

Patient is not being discharged home from the ED.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Education Intervention

Participants receive either enhanced overdose education or standard education before discharge from the emergency department

1 day

1 visit (in-person)

Follow-up

Participants are monitored for naloxone prescription fill rates and retention of educational content

4 weeks

1 follow-up survey (virtual)

Treatment Details

Interventions

• Enhanced Overdose Education (EOE)
• Standard education

Trial Overview The study aims to see if different types of overdose education can increase the rate at which people fill their naloxone prescriptions. Participants will get either standard written instructions via MyChart or a one-page handout and video explanation before they leave the hospital.

Participant Groups

Group I: Enhanced Overdose Education (EOE) Experimental Treatment 1 Intervention

A one-page education pamphlet handed to participants and their identified support individual and a 4-minute video clip that will be viewed in the hospital and emailed or texted to both. EOE is purposefully brief and intended to increase uptake by participants and their support network who may not be motivated or willing to engage in face-to-face or extensive education. The pamphlet and video both emphasize the Why and How. That is, the significance of naloxone in decreasing the likelihood of death following an overdose while providing simple instructions on how to use the nasal kit. They also emphasize an important point missing in standard education: to tell others in the support network where it is and how to use it.

Group II: Standard education Active Control 1 Intervention

Written instructions and information communicated to the patient through MyChart. The following four key points are covered: (1) When someone overdoses on opiates, their breathing will get very slow and may stop (2) Naloxone is a safe life-saving medication that can reverse an opioid overdose (3) You give someone naloxone by injecting it through the nostril, (4) If a first dose of naloxone does not work after about 3 minutes, give a second dose.

Enhanced Overdose Education (EOE) is already approved in United States for the following indications:

Approved in United States as Naloxone for:

• Emergency treatment of known or suspected opioid overdose

Who Is Running the Clinical Trial?

Hartford Hospital

Lead Sponsor

Trials

140

Recruited

19,700+

Hartford HealthCare

Collaborator

Trials

9

Recruited

1,300+

Findings from Research

Training patients in their homes on how to recognize opioid overdose symptoms and use the Naloxone auto-injector significantly improved their knowledge and response skills, with a statistically significant increase in correct identification of overdose response steps (p = 0.03).

The study faced challenges in feasibility due to insurance coverage issues, as 20 out of 40 enrolled patients withdrew because their insurance did not cover the cost of the Naloxone auto-injector.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility of employing a home healthcare model for education and treatment of opioid overdose using a naloxone auto-injector in a private practice pain medicine clinic. Dragovich, A., Brason, F., Beltran, T., et al.[2019]

In a study involving 42 healthy participants, the naloxone auto-injector (NAI) was significantly more effective than the intranasal delivery system (NXN) for administering naloxone during a simulated opioid overdose, with 90.5% success for NAI compared to 0% for NXN before training.

After training, 100% of participants successfully used NAI, while only 57.1% could use NXN, highlighting that NAI is easier to use and requires less training for effective administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Usability Study of a Novel Auto-Injector and an Intranasal System for Naloxone Delivery. Edwards, ET., Edwards, ES., Davis, E., et al.[2020]

Naloxone distribution and education are effective strategies for reducing opioid overdose deaths, as demonstrated by a case where a patient successfully reversed an overdose using an intranasal naloxone kit five months after receiving it during treatment.

Despite the successful reversal of an overdose, the patient omitted critical rescue response steps, highlighting the need for improved education on the complete response protocol when using naloxone in overdose situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful bystander-administered intranasal naloxone reversal of opioid overdose between two veterans: A case report. Ouyang, S., Moore, T.[2020]

A multidisciplinary naloxone education program (NEP) for hospitalized patients at high risk of opioid overdose significantly improved their knowledge and awareness of naloxone use, with a notable increase in assessment scores from 3.42 to 4.68 out of 5 questions (P = .0016).

Out of 95 screened patients, 19 completed the naloxone education, demonstrating the feasibility of implementing tailored educational interventions in a hospital setting to enhance patient safety upon discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a Pharmacist-Led, Multidisciplinary Naloxone Patient Education Program at an Academic Medical Center. Sze, J., Chan, T., Dalpoas, S., et al.[2023]

A study of 126 attendees from community support groups in Massachusetts found that most participants were motivated to receive overdose education and naloxone kits, primarily to have a rescue kit at home and to learn from others' experiences.

Among the attendees, 5 individuals successfully used naloxone during an overdose rescue, highlighting the practical effectiveness of training and access to naloxone in real-life situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overdose Education and Naloxone Rescue Kits for Family Members of Individuals Who Use Opioids: Characteristics, Motivations, and Naloxone Use. Bagley, SM., Peterson, J., Cheng, DM., et al.[2018]

Naloxone is a safe and effective antidote for opioid overdose, with a long history of use by healthcare professionals, and expanding access to it for high-risk individuals and their families is a key public health initiative.

While naloxone is generally safe, its administration can lead to varying levels of adverse reactions, especially with higher doses or intravenous use, highlighting the importance of training for non-healthcare professionals in recognizing overdoses and administering naloxone correctly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of naloxone safety for opioid overdose: practical considerations for new technology and expanded public access. Wermeling, DP.[2020]

Over 1,000 injection drug users were trained in naloxone administration through the SKOOP program in New York City, highlighting the effectiveness of training in preventing fatal heroin overdoses.

The program faced several challenges, including political issues and recruitment difficulties, but emphasized the importance of flexibility and participant feedback in successfully implementing naloxone distribution initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overdose prevention for injection drug users: lessons learned from naloxone training and distribution programs in New York City. Piper, TM., Rudenstine, S., Stancliff, S., et al.[2018]

In a study of 89 emergency department patients who experienced accidental opioid overdoses, 70% reported a history of previous overdoses, highlighting the ongoing crisis of opioid misuse.

Despite the availability of naloxone kits, only 31% of participants had access to one, and most who did reported no change in their opioid use patterns after obtaining naloxone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Naloxone Use Among Emergency Department Patients with Opioid Overdose. Marco, CA., Trautman, W., Cook, A., et al.[2018]

Naloxone infusion may be an effective treatment for opiate overdose, as demonstrated in two successful cases, suggesting it can help prevent patients from relapsing into narcosis after an overdose.

The extreme safety profile of naloxone makes it a favorable option for continuous infusion, particularly for treating overdoses from longer-acting narcotics like methadone, warranting further clinical trials to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous infusion of naloxone in the treatment of narcotic overdose. Bradberry, JC., Raebel, MA.[2019]

Overdose Education (OE) significantly improved knowledge about opioid overdose risks and naloxone use among 43 opioid users in a community treatment program, with knowledge gains maintained at a 3-month follow-up.

Despite the increase in overdose knowledge, the actual acquisition of naloxone was low, indicating that while education is beneficial, additional strategies may be needed to ensure naloxone access among individuals in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid overdose and naloxone education in a substance use disorder treatment program. Lott, DC., Rhodes, J.[2018]

Community-based overdose education and naloxone distribution (OEND) programs have shown effectiveness in training individuals to prevent opioid overdoses and administer naloxone, which is crucial for saving lives.

Translating OEND into conventional medical settings, where physicians can counsel patients on opioid overdose risks and prescribe naloxone, is an emerging practice that may significantly reduce overdose fatalities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Opioid Overdose Prevention and Naloxone Prescribing: Implications for Translating Community Programming Into Clinical Practice. Mueller, SR., Walley, AY., Calcaterra, SL., et al.[2018]

The personally-tailored opioid overdose prevention education and naloxone distribution (PTOEND) intervention significantly increased participants' knowledge about overdose and medication for opioid use disorder (MOUD), while also decreasing perceived barriers to treatment.

Participants reported a significant reduction in opioid use and overdose-risk behaviors, with 65% utilizing naloxone, indicating that PTOEND effectively promotes harm reduction and readiness for treatment among illicit opioid users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a personally-tailored opioid overdose prevention education and naloxone distribution intervention to promote harm reduction and treatment readiness in individuals actively using illicit opioids. Winhusen, T., Wilder, C., Lyons, MS., et al.[2022]

Online opioid overdose education significantly improved knowledge about overdose signs and naloxone administration, with average scores increasing from 6.82 to 8.22 out of 9 after training.

Participants who received a naloxone kit had significantly higher possession rates compared to those who only received instructions on obtaining a kit, highlighting barriers to accessing naloxone through pharmacies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary effectiveness of online opioid overdose and naloxone administration training and impact of naloxone possession on opioid use. Sisson, ML., Azuero, A., Chichester, KR., et al.[2023]

The study involved 13 codesign workshops over 9 months with stakeholders, including opioid users and healthcare providers, to develop a take-home naloxone (THN) kit aimed at improving responses to opioid overdoses.

The final THN kit prototype integrates ultra-brief training and nasal naloxone packaging, designed for distribution in various healthcare and community settings, addressing gaps in existing overdose education and emphasizing timely response and stigma reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design details for overdose education and take-home naloxone kits: Codesign with family medicine, emergency department, addictions medicine and community. Sellen, K., Goso, N., Halleran, L., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

The feasibility of employing a home healthcare model for education and treatment of opioid overdose using a naloxone auto-injector in a private practice pain medicine clinic. [2019]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Comparative Usability Study of a Novel Auto-Injector and an Intranasal System for Naloxone Delivery. [2020]

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

Successful bystander-administered intranasal naloxone reversal of opioid overdose between two veterans: A case report. [2020]

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

Implementation of a Pharmacist-Led, Multidisciplinary Naloxone Patient Education Program at an Academic Medical Center. [2023]

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

Overdose Education and Naloxone Rescue Kits for Family Members of Individuals Who Use Opioids: Characteristics, Motivations, and Naloxone Use. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Review of naloxone safety for opioid overdose: practical considerations for new technology and expanded public access. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Overdose prevention for injection drug users: lessons learned from naloxone training and distribution programs in New York City. [2018]

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

Naloxone Use Among Emergency Department Patients with Opioid Overdose. [2018]

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

Continuous infusion of naloxone in the treatment of narcotic overdose. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Opioid overdose and naloxone education in a substance use disorder treatment program. [2018]

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

A Review of Opioid Overdose Prevention and Naloxone Prescribing: Implications for Translating Community Programming Into Clinical Practice. [2018]

12. Ireland pubmed.ncbi.nlm.nih.gov

Evaluation of a personally-tailored opioid overdose prevention education and naloxone distribution intervention to promote harm reduction and treatment readiness in individuals actively using illicit opioids. [2022]

13. Ireland pubmed.ncbi.nlm.nih.gov

Preliminary effectiveness of online opioid overdose and naloxone administration training and impact of naloxone possession on opioid use. [2023]

14. England pubmed.ncbi.nlm.nih.gov

Design details for overdose education and take-home naloxone kits: Codesign with family medicine, emergency department, addictions medicine and community. [2022]