Vending Machine Naloxone Distribution for Your Community (VENDY)

Opioid Overdose Clinical Trial

Official title:

Vending Machine Naloxone Distribution for Your Community (VENDY): Increasing Reach and Implementation of Naloxone Distribution

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06429436
• Other study ID #: 22-0546
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 1, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: May 2024
• Source: University of Colorado, Denver
• Contact: Nicole Wagner, PhD
• Phone: (303)724-7095
• Email: nicole.wagner[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This pilot assessment of the VENDY program will take place in 3 communities. Each community will have a machine (vending or kiosks) in which naloxone will be distributed for free to community members. Our preliminary work identified the locations desired by community members who use illegal drugs for machine placement. The pilot test test will include evaluation of the reach (naloxone distribution), adoption (% of sites and staff implementing), and implementation (fidelity to restocking and maintenance protocol) of VENDY in each community.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1489
• Est. completion date: January 1, 2026
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Any person in the community who desires to obtain naloxone will be able to use the machines

Exclusion Criteria:

• Inability to enter a code on a vending machine or open a kiosk.

Related Conditions & MeSH terms

• Harm Reduction
• Naloxone
• Opiate Overdose
• Opioid Overdose

Intervention

Behavioral:
• VENDY
At least 1 machine (vending machine like a snack machine or a machine like a newspaper kiosk) will be placed in the respective community served by the participating organizations. Any person in the community can get naloxone from the machine. The vending machine will require a code that will be placed on the machine for anyone to use. The kiosks are a box that you simply pull open and naloxone can be obtained. Naloxone kits will be provided for free as part of the current naloxone distribution program within each respective organization.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University of Colorado, Denver	Denver Health and Hospital Authority, Southern Colorado Harm Reduction Association, Summit County Public Health Department

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reach	Reach will be assessed using monthly counts of naloxone distribution in the 6 months before and after VENDY implementation. Naloxone counts will include distribution from all sources within the organization and captured through pharmacy fills from the electronic health record and distribution tracking logs. Naloxone machine distribution will be added to the total monthly count in the post implementation phase and obtained using the vending machine electronic software (reporting date and time of distribution) or (for kiosks) the staff monthly refill tracking log capturing quantity of naloxone kits required to fill the machine (captured at least monthly).	the 6 months pre VENDY implementation and the 6 months post VENDY implementation
Secondary	Adoption	Adoption is the percentage of sites placing a naloxone vending machine in the respective community that is made available for community members to obtain naloxone.	At the end of program development (program development is the first phase in which each site is developing VENDY over a 6-18 month period of time)
Secondary	Fatal Opioid Overdose Events-Effectiveness	The count of fatal opioid overdose events for each respective county in which the participating organization and vending machine reside in the year before and year after VENDY implementation. Overdose will be captured from publicly available data from death records reported by the Colorado Department of Public Health and Environment. To address temporality we will include fatal opioid overdose deaths in a comparison community matching community features (urban/rural status, community population, and opioid death rate).	pre-implementation in the year prior to a live VENDY program and post implementation in the year following live VENDY program
Secondary	Fidelity-Implementation	Fidelity is the percentage of time staff refill and maintain the machine per protocol as measured by the vending machine software and machine activity tracking log.	the 6 months following VENDY implementation
Secondary	Maintenance	Number of months each organization implementing VENDY continues to make naloxone available in the machines for the 6 months following the initial implementation phase (6 months).	the 6 months following the initial implementation phase (6 months)