Naloxone for Opioid Overdose

Recruiting at 2 trial locations

Overseen By Meagan R Bean, MPH

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Colorado, Denver

Disqualifiers: Inability to use machine

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

1489 Participants Needed

Trial Summary

What is the purpose of this trial?

Vending machines are an innovative strategy shown to increase access to naloxone, a medication used to reverse opioid overdose. The aim of this proposal is to study the reach of a community-initiated, stakeholder engaged adaptation of naloxone distribution, VEnding machine Naloxone Distribution for Your community (VENDY) program.

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 the drug VENDY for opioid overdose?

Research shows that naloxone, a drug similar to VENDY, is effective in reversing opioid overdoses by quickly counteracting the life-threatening effects of opioids. Community programs distributing naloxone have reported thousands of successful overdose reversals, highlighting its effectiveness in emergency situations. ^{1 2 3 4 5}

Is naloxone safe for use in humans?

Naloxone is generally considered safe and has been used successfully for many years to reverse opioid overdoses. However, it can cause withdrawal symptoms in opioid-dependent individuals and, in rare cases, serious effects like pulmonary edema (fluid in the lungs) and cardiac issues, especially at higher doses or with rapid infusion. ^{6 7 8 9 10}

How does the drug VENDY differ from other treatments for opioid overdose?

VENDY, also known as naloxone, is unique because it is an opioid antagonist that can quickly reverse the effects of an opioid overdose, restoring breathing and consciousness. Unlike other treatments, it is available in a nasal spray form, making it easy to administer by non-medical individuals in emergency situations. ^{2 11 12 13 14}

Research Team

Nicole Wagner, PhD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

The VENDY clinical trial is open to any community member who wishes to obtain naloxone, a medication for reversing opioid overdoses. The only requirement is the ability to enter a code on a vending machine and open a kiosk.

Inclusion Criteria

I want to get naloxone from a machine.

Exclusion Criteria

I cannot enter codes on machines or open kiosks due to my condition.

Timeline

Program Development

Each site develops the VENDY program over a 6-18 month period

6-18 months

Implementation

Vending machines are installed and naloxone distribution begins

6 months

Monthly monitoring and restocking

Follow-up

Participants are monitored for reach, adoption, and effectiveness of naloxone distribution

12 months

Maintenance

Continued availability of naloxone in machines post-implementation

6 months

Treatment Details

Interventions

• VENDY

Trial Overview This study tests the effectiveness of distributing naloxone through vending machines (VENDY program) as an innovative approach to increase access and potentially save lives from opioid overdoses in communities.

Participant Groups

Group I: VENDY Experimental Treatment 1 Intervention

Each participating site will install at least 1 machine (vending or kiosks) in the respective community for naloxone distribution.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Southern Colorado Harm Reduction Association

Collaborator

Trials

1

Recruited

1,500+

Denver Health and Hospital Authority

Collaborator

Trials

106

Recruited

403,000+

Summit County Public Health Department

Collaborator

Trials

1

Recruited

1,500+

Findings from Research

In a study of 241 adults at high risk for opioid overdose, combining overdose education and take-home naloxone did not significantly reduce the risk of overdose events compared to usual care, with 24% experiencing at least one overdose during follow-up.

The high rates of overdose and healthcare utilization suggest that more intensive interventions, such as housing support and opioid agonist treatments, may be necessary to effectively address the needs of this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impacts of an opioid overdose prevention intervention delivered subsequent to acute care. Banta-Green, CJ., Coffin, PO., Merrill, JO., et al.[2022]

Heroin overdoses have become more common, with risk factors including recent abstinence and polydrug use, highlighting the urgent need for effective prevention strategies.

Naloxone is a safe and effective treatment for reversing heroin overdose effects, as it quickly counteracts respiratory depression and sedation, making it a crucial tool for overdose prevention in communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prescription naloxone: a novel approach to heroin overdose prevention. Sporer, KA., Kral, AH.[2022]

An educational intervention that included distributing 200 naloxone kits and providing training on opioid overdose significantly improved knowledge among participants, with average test scores increasing from 5.5 to 7.5 out of 10 after the training.

The training was effective across all demographics, with both male and female participants showing substantial improvements in their understanding of naloxone use, indicating that such educational efforts can enhance the effectiveness of harm reduction strategies in opioid overdose situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Study on the Efficacy of a Naloxone Training Program. Beauchamp, GA., Cuadrado, HM., Campbell, S., et al.[2021]

Since 1996, community-based programs have trained over 53,000 individuals and distributed naloxone, leading to 10,171 reported reversals of opioid overdoses, highlighting the efficacy of naloxone in preventing fatal outcomes from opioid overdoses.

Naloxone is specifically effective for reversing opioid overdoses, but it does not work on non-opioid overdoses, emphasizing the need for targeted education and distribution of naloxone among those at risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based opioid overdose prevention programs providing naloxone - United States, 2010. [2022]

Rates of multiple naloxone administrations (MNA) for opioid overdose reversal vary widely, with EMS-based studies showing rates from 9% to 53%, while bystander-reported studies indicate rates as high as 89%.

There has been a significant increase in MNA rates over time, with some studies reporting annual increases between 26% and 43%, highlighting the need for higher naloxone formulations to address the challenges posed by potent synthetic opioids like illicitly manufactured fentanyl.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The need for multiple naloxone administrations for opioid overdose reversals: A review of the literature. Abdelal, R., Banerjee, AR., Carlberg-Racich, S., et al.[2022]

Naloxone is generally considered safe for treating opioid overdoses, but in two reported cases, young patients experienced serious adverse effects, specifically non-cardiogenic pulmonary edema (NCPE), after requiring frequent dosing due to its short half-life.

These cases highlight the need for further research to establish standardized dosing guidelines for naloxone to prevent life-threatening complications and reduce the burden on healthcare resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Naloxone-Induced Acute Pulmonary Edema is Dose-Dependent: A Case Series. Al-Azzawi, M., Alshami, A., Douedi, S., et al.[2021]

Buprenorphine/naloxone has a unique pharmacology that provides a ceiling effect on its cardio-respiratory depressant properties, making it potentially safer than other opioids, especially at higher doses.

Data from various safety monitoring systems indicate that buprenorphine/naloxone has a favorable safety profile compared to other opioids and psychotropic drugs, suggesting it may reduce the risk of overdose-related morbidity and mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Question About the Safety of Buprenorphine/Naloxone and Benzodiazepine Drugs. Howland, RH.[2015]

The DOPE Project trained 1,942 individuals in San Francisco to use naloxone, with 11% reporting they used it during an overdose event, demonstrating a willingness among injection drug users to learn and apply overdose response strategies.

Naloxone was highly effective, with 89% of overdose events reversed when naloxone was administered, and fewer than 1% of participants reported serious adverse effects, highlighting its safety and efficacy as a life-saving intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overdose prevention and naloxone prescription for opioid users in San Francisco. Enteen, L., Bauer, J., McLean, R., et al.[2021]

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]

Naloxone is a safe and effective opioid receptor antagonist used to treat opioid overdose and prevent abuse in opioid-dependent patients, with a long history of clinical success and a wide therapeutic dose range (up to 10 mg).

However, naloxone can induce acute withdrawal symptoms in opioid-dependent patients, and its effects may wear off too soon during overdose treatment, necessitating careful monitoring of patients' cardiorespiratory status after administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Naloxone treatment in opioid addiction: the risks and benefits. van Dorp, E., Yassen, A., Dahan, A.[2019]

A comprehensive naloxone training program for 122 injection drug users in New York City showed that naloxone can be effectively administered, with 83% of those who received it surviving an overdose.

The study indicates that equipping drug users with naloxone and training them to use it is feasible and could significantly reduce overdose deaths, as 82.2% of participants felt comfortable using naloxone in emergencies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a naloxone distribution and administration program in New York City. Piper, TM., Stancliff, S., Rudenstine, S., et al.[2022]

Non-fentanyl-derived synthetic opioids (NSOs) like U-47700 and butyrfentanyl pose significant risks of abuse and overdose, highlighting the need for effective treatment options.

Naloxone has been shown to successfully reverse the effects of NSO overdoses, restoring independent breathing in patients, making it a crucial medication for managing these emergencies and advocating for its wider availability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating Non-fentanyl-derived Synthetic Opioid Overdose with a Traditional Opioid Reversal Agent. Acuna, VS., Abels, EM., Alhelwani, A., et al.[2020]

A 23-year-old patient experienced pulmonary edema and lung injury shortly after receiving naloxone for opioid overdose, highlighting a potential complication of naloxone treatment.

The use of non-invasive positive pressure ventilation effectively improved the patient's symptoms and lung condition within hours, suggesting it should be considered for managing naloxone-induced pulmonary complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid antidote induced pulmonary edema and lung injury. Yarlagadda, K., Kim, J., Kanderi, T., et al.[2022]

The new 4 mg intranasal naloxone formulation (Narcan®) was highly effective in reversing opioid overdoses, with a success rate of 98.8% reported in 242 out of 245 cases surveyed by first responders and community organizations.

Most overdose reversals occurred quickly, with 73.5% of cases responding within 5 minutes, highlighting the formulation's rapid action in emergency situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of naloxone nasal spray 4 mg in the community setting: a survey of use by community organizations. Avetian, GK., Fiuty, P., Mazzella, S., et al.[2019]

References

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

Impacts of an opioid overdose prevention intervention delivered subsequent to acute care. [2022]

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

Prescription naloxone: a novel approach to heroin overdose prevention. [2022]

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

A Study on the Efficacy of a Naloxone Training Program. [2021]

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

Community-based opioid overdose prevention programs providing naloxone - United States, 2010. [2022]

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

The need for multiple naloxone administrations for opioid overdose reversals: A review of the literature. [2022]

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

Naloxone-Induced Acute Pulmonary Edema is Dose-Dependent: A Case Series. [2021]

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

A Question About the Safety of Buprenorphine/Naloxone and Benzodiazepine Drugs. [2015]

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

Overdose prevention and naloxone prescription for opioid users in San Francisco. [2021]

9. England pubmed.ncbi.nlm.nih.gov

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

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

Naloxone treatment in opioid addiction: the risks and benefits. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Evaluation of a naloxone distribution and administration program in New York City. [2022]

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

Treating Non-fentanyl-derived Synthetic Opioid Overdose with a Traditional Opioid Reversal Agent. [2020]

13. England pubmed.ncbi.nlm.nih.gov

Opioid antidote induced pulmonary edema and lung injury. [2022]

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

Use of naloxone nasal spray 4 mg in the community setting: a survey of use by community organizations. [2019]