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Active, Not Recruiting

NCT Number: NCT06429436

Vending Machine Naloxone Distribution for Your Community (VENDY)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Harm Reduction Behavior Chemically-Induced Disorders Drug Misuse Drug Overdose Mental Disorders Naloxone Narcotic-Related Disorders Opiate Overdose Opioid Overdose Opioid-Related Disorders Prescription Drug Misuse Substance-Related Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Denver Health, Denver, Colorado, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VENDY

Behavioral

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.

Primary outcomes

  1. Reach

    Time frame: the 6 months pre VENDY implementation and the 6 months post VENDY implementation

    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).

Secondary outcomes

  1. Adoption

    Time frame: 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)

    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.

  2. Fatal Opioid Overdose Events-Effectiveness

    Time frame: pre-implementation in the year prior to a live VENDY program and post implementation in the year following live VENDY program

    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).

  3. Fidelity-Implementation

    Time frame: the 6 months following VENDY 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.

  4. Maintenance

    Time frame: the 6 months following the initial implementation phase (6 months)

    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).

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Denver Health and Hospital Authority
  • Southern Colorado Harm Reduction Association
  • Summit County Public Health

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 28, 2024
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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