A Phase 4 interventional study of VENDY in Harm Reduction, Naloxone and Opioid Overdose, sponsored by University of Colorado, Denver. Active, not recruiting at 3 sites in United States. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by University of Colorado, Denver · Phase 4, Interventional, and Health services research
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.
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.
115 studies on the registry are indexed under Harm Reduction; 39 are open to participants now.
This study's planned enrollment of 4,000 is above the median of 139 across 92 interventional studies indexed under Harm Reduction.
Browse Harm Reduction studies →University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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).
Time frame: the 6 months pre VENDY implementation and the 6 months post VENDY implementation
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.
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)
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).
Time frame: pre-implementation in the year prior to a live VENDY program and post implementation in the year following live VENDY program
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.
Time frame: the 6 months following VENDY implementation
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).
Time frame: the 6 months following the initial implementation phase (6 months)
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
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.
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.
No publications or documents are linked to this record.
Ran from Jun 2024 to primary completion in Feb 2026, 20 months.
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This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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