## Protocol Section
### Identification Module
**NCT ID:** NCT06429436

**Brief Title:** Vending Machine Naloxone Distribution for Your Community (VENDY)

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

#### Organization Study ID Info
**ID:** 22-0546
#### Organization
**Class:** OTHER
**Full Name:** University of Colorado, Denver
### Status Module
#### Completion Date
**Date:** 2026-01-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Southern Colorado Harm Reduction Association

**Class:** OTHER

**Name:** Denver Health and Hospital Authority

**Class:** UNKNOWN

**Name:** Summit County Public Health Department

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Colorado, Denver

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**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.

**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 Module

**Conditions:**

- Harm Reduction

- Naloxone

- Opioid Overdose

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention 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 Info

**Masking:** NONE

**Masking Description:** There will be no masking.

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 1489

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Behavioral: VENDY

**Label:** VENDY

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- VENDY

**Description:** 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.

**Name:** VENDY

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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).

**Measure:** Reach

**Time Frame:** the 6 months pre VENDY implementation and the 6 months post VENDY implementation

#### Secondary Outcomes

**Description:** 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.

**Measure:** 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)

**Description:** 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).

**Measure:** 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

**Description:** 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.

**Measure:** Fidelity-Implementation

**Time Frame:** the 6 months following VENDY implementation

**Description:** 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).

**Measure:** Maintenance

**Time Frame:** the 6 months following the initial implementation phase (6 months)

### Eligibility Module

**Eligibility Criteria:** 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.

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** nicole.wagner@cuanschutz.edu

**Name:** Nicole Wagner, PhD

**Phone:** (303)724-7095

**Role:** CONTACT

**Contact 2:**

**Email:** meagan.bean@cuanschutz.edu

**Name:** Meagan R Bean, MPH

**Phone:** (303)724-7095

**Role:** CONTACT

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000062787

- Term: Drug Overdose

- ID: D000063487

- Term: Prescription Drug Misuse

- ID: D000076064

- Term: Drug Misuse

- ID: D000019966

- Term: Substance-Related Disorders

- ID: D000064419

- Term: Chemically-Induced Disorders

- ID: D000001523

- Term: Mental Disorders

- ID: D000009293

- Term: Opioid-Related Disorders

- ID: D000079524

- Term: Narcotic-Related Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC25

- Name: Substance Related Disorders

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M2423

- Name: Opiate Overdose

- Relevance: HIGH

- As Found: Opioid Overdose

- ID: M30011

- Name: Drug Overdose

- Relevance: LOW

- As Found: Unknown

- ID: M1557

- Name: Drug Misuse

- Relevance: LOW

- As Found: Unknown

- ID: M30133

- Name: Prescription Drug Misuse

- Relevance: LOW

- As Found: Unknown

- ID: M21837

- Name: Substance-Related Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M30302

- Name: Chemically-Induced Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M12244

- Name: Opioid-Related Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M2057

- Name: Narcotic-Related Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000083682

- Term: Opiate Overdose

### Intervention Browse Module - Browse Branches

- Abbrev: NarcAntag

- Name: Narcotic Antagonists

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M12221

- Name: Naloxone

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
