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

4000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to distribute naloxone, a medication that reverses opioid overdoses, to those in need. By using vending machines or kiosks, the trial aims to increase naloxone accessibility in communities. This approach could save lives by quickly providing the medication to those at risk of an overdose. Anyone in the community who wants naloxone can participate, provided they can use the vending machine or kiosk. As a Phase 4 trial, this research explores how this FDA-approved and effective treatment can benefit more patients.

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 is the safety track record for this treatment?

Research has shown that naloxone, the treatment used in the VENDY program, is safe for people. The FDA has already approved it to reverse opioid overdoses. Studies have found that administering naloxone through community programs can reduce overdose deaths without major safety issues.

Past use of naloxone indicates it is generally well-tolerated. Most people do not experience serious side effects. Some may feel dizzy or flushed, but these effects are usually mild. The VENDY program focuses on increasing access to naloxone, not altering the medication itself.

In summary, naloxone is considered safe, and the VENDY program aims to make this life-saving treatment more accessible. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the VENDY treatment for opioid overdose because it revolutionizes how naloxone is distributed. Unlike traditional methods where naloxone is primarily available through pharmacies or emergency responders, VENDY uses vending machines or kiosks to make this life-saving medication more accessible directly within communities. This new delivery method aims to ensure that naloxone is available 24/7 in high-risk areas, potentially saving more lives by getting the antidote to those who need it faster and more conveniently.

What evidence suggests that the VENDY program is effective for increasing access to naloxone?

Research shows that naloxone effectively reverses opioid overdoses. Studies have found that community programs distributing naloxone can help prevent overdose deaths. For instance, one study found that increased naloxone distribution could reduce opioid overdose deaths by up to 9% annually. Another study suggested that these programs might have curbed large increases in drug overdose deaths. This trial uses vending machines to distribute naloxone, aiming to make this life-saving treatment more accessible to those in need. ^{1 4 5 6 7}

Who Is on the Research Team?

Nicole Wagner, PhD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Summit County Public Health

Collaborator

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06429436

Vending Machine Naloxone Distribution for Your ... Reach will be assessed using monthly counts of naloxone distribution in the 6 months before and after VENDY implementation. Naloxone counts will include ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11934755/

Effectiveness of naloxone distribution in community ... The authors concluded that the naloxone distribution program may have helped avert the large increases in drug overdose deaths that accompanied ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2819204

Evaluation of Strategies to Enhance Community-Based ... Distributing more naloxone supported by the state's opioid settlement was projected to reduce annual opioid overdose deaths (OODs) by up to 9% with an ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40133970/

Effectiveness of naloxone distribution in community ... Conclusions: Community-based naloxone distribution programs can be effective in preventing opioid overdose deaths. The paper demonstrates ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871625002364

A geospatial analysis of naloxone distribution patterns in ... This study describes the distribution and administration of naloxone throughout one state heavily impacted by the opioid overdose crisis.

6. denvergov.org denvergov.org/Government/Agencies-Departments-Offices/Agencies-Departments-Offices-Directory/Public-Health-Environment/Community-Behavioral-Health/Behavioral-Health-Strategies/Overdose-Prevention

Overdose Prevention The Overdose Education and Naloxone Distribution Program aims to improve treatment access and retention and reduce harm associated with drug use.

7. denverhealth.org denverhealth.org/news/2025/01/denver-health-introduces-naloxone-vending-machine

Denver Health introduces naloxone vending machine The vending machine distributes packages containing two doses of naloxone which are available at no cost with the code displayed on the machine.