Vending Machine Naloxone Distribution for Your Community (VENDY)

May 29, 2026 updated by: University of Colorado, Denver

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

4000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80204
        • Denver Health
      • Frisco, Colorado, United States, 80443
        • Summit County Public Health Department
      • Pueblo, Colorado, United States, 81004
        • Southern Colorado Harm Reduction Association

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VENDY
Each participating site will install at least 1 machine (vending or kiosks) in the respective community for naloxone distribution.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
the 6 months pre VENDY implementation and the 6 months post VENDY implementation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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).
pre-implementation in the year prior to a live VENDY program and post implementation in the year following live VENDY program
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.
the 6 months following VENDY implementation
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).
the 6 months following the initial implementation phase (6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

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

Investigators

  • Principal Investigator: Nicole Wagner, PhD, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Actual)

February 28, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

May 10, 2024

First Submitted That Met QC Criteria

May 20, 2024

First Posted (Actual)

May 28, 2024

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-0546

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data obtained through this study may be provided to qualified researchers with academic interest in related areas of interest. Data shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (e.g., data use/sharing agreements) are prerequisites to the sharing of data with the requesting party. Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement.

IPD Sharing Time Frame

Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months.

IPD Sharing Access Criteria

Data obtained through this study may be provided to qualified researchers with academic interest in related areas of interest. Data shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (e.g., data use/sharing agreements) are prerequisites to the sharing of data with the requesting party. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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