Vending Machine Naloxone Distribution for Your Community (VENDY)

NCT06429436 | Recruiting Phase 4

• 1 other identifier: 22-0546
• Study Type: interventional
• Target: 4,000
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Harm Reduction; Naloxone; Opioid Overdose

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Adoption

  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

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

• Fidelity-Implementation

  the 6 months following VENDY implementation

• Maintenance

  the 6 months following the initial implementation phase (6 months)

Study Arms (1)

VENDY

EXPERIMENTAL

Each participating site will install at least 1 machine (vending or kiosks) in the respective community for naloxone distribution.

Behavioral: VENDY

Interventions

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.

VENDY

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Southern Colorado Harm Reduction Association: collaborator
• Denver Health and Hospital Authority: collaborator
• Summit County Public Health: collaborator

Study Sites (3)

Denver Health

Denver, Colorado, 80204, United States

RECRUITING

Summit County Public Health Department

Frisco, Colorado, 80443, United States

RECRUITING

Southern Colorado Harm Reduction Association

Pueblo, Colorado, 81004, United States

RECRUITING

MeSH Terms

Conditions

Harm Reduction; Opiate Overdose

Condition Hierarchy (Ancestors)

Behavior; Drug Overdose; Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Narcotic-Related Disorders; Mental Disorders

Study Officials

• Nicole Wagner, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Wagner, PhD

CONTACT

(303)724-7095; nicole.wagner@cuanschutz.edu

Meagan R Bean, MPH

CONTACT

(303)724-7095; meagan.bean@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: There will be no masking.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will be using an interrupted time series design to evaluate naloxone distribution before and after vending machine implementation in each community.

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 28, 2024
• Study Start: June 1, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

US (3)