Harm ReductionPhase 4NCT06429436
Vending Machine Naloxone Distribution for Your Community (VENDY)
A Phase 4 study testing VENDY in people with Harm Reduction and Naloxone, run by University of Colorado, Denver at 3 sites in United States.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Harm Reduction, Naloxone, Opioid Overdose
- What is being tested?
- VENDY
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jun 2024to 30 Jun 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any person in the community who desires to obtain naloxone will be able to use the machines
Who cannot join
- Inability to enter a code on a vending machine or open a kiosk.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Denver Health
Denver, Colorado, 80204
Summit County Public Health Department
Frisco, Colorado, 80443
Southern Colorado Harm Reduction Association
Pueblo, Colorado, 81004
About this study
Official title: 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.
Read the 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.
- Conditions
- Harm Reduction, Naloxone, Opioid Overdose
- Being tested
- VENDY
- Medical subject headings
- Harm Reduction, Opiate Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VENDYBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| VENDY | Experimental | Each participating site will install at least 1 machine (vending or kiosks) in the respective community for naloxone distribution. Receives: Behavioral: VENDY |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: the 6 months pre VENDY implementation and the 6 months post VENDY implementation
Secondary outcomes (4)
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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: the 6 months following the initial implementation phase (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start1 Jun 2024
- Primary completion28 Feb 2026
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Harm ReductionStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- We will be using an interrupted time series design to evaluate naloxone distribution before and after vending machine implementation in each community.
- Masking
- None (open label)
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Southern Colorado Harm Reduction Association, Denver Health and Hospital Authority, Summit County Public Health
- Responsible party
- Sponsor
- Investigators
- Nicole Wagner, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06429436
- Sponsor's protocol ID
- 22-0546
- Status last verified
- May 2026
- First submitted
- 10 May 2024
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vending Machine Naloxone Distribution for Your Community (VENDY): Increasing Reach and Implementation of Naloxone Distribution
- ClinicalTrials.gov ID
- NCT06429436
- Acronym / sponsor ID
- 22-0546
- Conditions
- Harm Reduction, Naloxone, Opioid Overdose
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Southern Colorado Harm Reduction Association, Denver Health and Hospital Authority, Summit County Public Health
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- We will be using an interrupted time series design to evaluate naloxone distribution before and after vending machine implementation in each community.
| Arm | Type | Receives |
|---|---|---|
| VENDY | Experimental | Behavioral: VENDYEach participating site will install at least 1 machine (vending or kiosks) in the respective community for naloxone distribution. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Any person in the community who desires to obtain naloxone will be able to use the machines
Key exclusion criteria (1 listed)
- Inability to enter a code on a vending machine or open a kiosk.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VENDYAt 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. | Behavioural | VENDY |
Primary outcome
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).
4 secondary outcomes
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)
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
Fidelity-Implementation
Time frame: the 6 months following VENDY implementation
Maintenance
Time frame: the 6 months following the initial implementation phase (6 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Wagner, PhD principal investigator
University of Colorado, Denver
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing VENDY in people with Harm Reduction and Naloxone, run by University of Colorado, Denver at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach (time frame: the 6 months pre VENDY implementation and the 6 months post VENDY implementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.