NCT06727786

Brief Summary

This study evaluates the efficacy of a serious game to teach students how to recognize and respond to opioid overdose

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
850

participants targeted

Target at P75+ for phase_2

Timeline
19mo left

Started Feb 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Feb 2026Dec 2027

First Submitted

Initial submission to the registry

December 3, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 11, 2024

Completed
1.1 years until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

December 11, 2024

Status Verified

December 1, 2024

Enrollment Period

10 months

First QC Date

December 3, 2024

Last Update Submit

December 5, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Naloxone administration Skill

    Properly administer naloxone to a victim of opioid overdose Study personnel will ask students to administer naloxone to a CPR manikin. Personnel will use a checklist from the Center for Addiction and Mental Health to score student responses.

    Day of training, and 2-3 months

Secondary Outcomes (3)

  • CPR Skill

    Day of training, and 2-3 months

  • Attitudes towards opioid overdose

    Day of training, and 2-3 months

  • Knowledge of opioid overdose response

    Day of training, and 2-3 months

Study Arms (2)

Control

NO INTERVENTION

No intervention/training

Serious Game

EXPERIMENTAL

Serious Game training to respond to opioid overdose

Other: Serious game training

Interventions

A serious game featuring a dramatic/realistic film, pauses with questions for active learning, and practice administration of naloxone and performing CPR

Serious Game

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Student at participating school, enrolled in Health or Science Class

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Opiate Overdose

Condition Hierarchy (Ancestors)

Drug OverdosePrescription Drug MisuseDrug MisuseSubstance-Related DisordersChemically-Induced DisordersOpioid-Related DisordersNarcotic-Related DisordersMental Disorders

Central Study Contacts

Associate Professor, MD

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2024

First Posted

December 11, 2024

Study Start

February 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

December 11, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Participants are minors and therefore protected. No IDP will be shared