Opioid OverdosePhase 2NCT06727786
Serious Game to Teach Opioid Overdose Response
A Phase 2 study testing Serious game training in people with Opioid Overdose, run by University of Nevada, Reno.
Trial summary
This study evaluates the efficacy of a serious game to teach students how to recognize and respond to opioid overdose Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Overdose
- What is being tested?
- Serious game training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 850 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 1 Dec 2027
- Phase
- Phase 2
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Student at participating school, enrolled in Health or Science Class
Who cannot join
- None
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Using a Serious Game to Teach People How to Recognize and Respond to Opioid Overdose
This study evaluates the efficacy of a serious game to teach students how to recognize and respond to opioid overdose
Read the detailed description
This study uses an interactive realistic film depicting an opioid overdose to teach high school/middle school students how to recognize and respond to opioid overdose. The film features a person who finds their friend unresponsive, with evidence of opioid use. The unresponsive friend demonstrates signs of opioid overdose. The hero must recognize opioid overdose, administer naloxone (opioid antedote) and perform CPR. The film is made interactive by the narrator pausing the action of the film, and asking learners to answer questions/make choices.
Efficacy is tested on the day of training, and 2-4 months later. Efficacy is measured by student ability to correctly administer naloxone to a manikin, perform CPR, and answer knowledge questions about opioid overdose. Other studied metrics include student engagement/enjoyment, attitudes/biases, and emotions created by the training. These will be tested through validated questionnaires.
- Conditions
- Opioid Overdose
- Being tested
- Serious game training
- Medical subject headings
- Opiate Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serious game trainingOther
A serious game featuring a dramatic/realistic film, pauses with questions for active learning, and practice administration of naloxone and performing CPR
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No intervention/training |
| Serious Game | Experimental | Serious Game training to respond to opioid overdose Receives: Other: Serious game training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day of training, and 2-3 months
Secondary outcomes (3)
CPR Skill
Ability to perform high-quality CPR Students will be asked to perform CPR on a CPR manikin for 2 minutes. CPR skill will be measured with the CPR Meter 2 from Laerdal, which reports compression rate, depth, and percent recoil. We will consider "high quality CPR" students who perform 70% or more of compressions at appropriate rate (100-120/min), depth (2-2.5inches), and full recoil.
Measured: Day of training, and 2-3 months
Attitudes towards opioid overdose
Attitudes, enjoyment, and emotions towards opioid overdose
Emotions will be measured using the PANAS scale (Positive And Negative Affect Scale) which consists of 10 positive and 10 negative emotion words. The total score is calculated by finding the sum of the 10 positive items, and then the 10 negative items. Scores range from 10 - 50 for both sets of items. For the total positive score, a higher score indicates more of a positive affect.
Engagement and enjoyment will be measured using Likert-style questions asking for agreement with statements such as "I enjoyed CPR training," "CPR training was fun," "I will use CPR training in the future," "It is important to learn CPR"
Attitudes will be measured with a custom questionnaire asking Likert-style responses to statements regarding opioid overdose.
Measured: Day of training, and 2-3 months
Knowledge of opioid overdose response
Knowledge of how to recognize and respond to opioid overdose A questionnaire of custom-created multiple choice questions will assess student knowledge of how to recognize and respond to opioid overdose.
Measured: Day of training, and 2-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start1 Feb 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid OverdoseStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Reno
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727786
- Sponsor's protocol ID
- 2159620
- Status last verified
- Dec 2024
- First submitted
- 3 Dec 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants are minors and therefore protected. No IDP will be shared
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Serious Game to Teach People How to Recognize and Respond to Opioid Overdose
- ClinicalTrials.gov ID
- NCT06727786
- Acronym / sponsor ID
- 2159620
- Conditions
- Opioid Overdose
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- University of Nevada, RenoUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 11 Dec 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.
This study evaluates the efficacy of a serious game to teach students how to recognize and respond to opioid overdose
Detailed description
This study uses an interactive realistic film depicting an opioid overdose to teach high school/middle school students how to recognize and respond to opioid overdose. The film features a person who finds their friend unresponsive, with evidence of opioid use. The unresponsive friend demonstrates signs of opioid overdose. The hero must recognize opioid overdose, administer naloxone (opioid antedote) and perform CPR. The film is made interactive by the narrator pausing the action of the film, and asking learners to answer questions/make choices.
Efficacy is tested on the day of training, and 2-4 months later. Efficacy is measured by student ability to correctly administer naloxone to a manikin, perform CPR, and answer knowledge questions about opioid overdose. Other studied metrics include student engagement/enjoyment, attitudes/biases, and emotions created by the training. These will be tested through validated questionnaires.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No intervention/training |
| Serious Game | Experimental | Other: Serious game trainingSerious Game training to respond to opioid overdose |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Student at participating school, enrolled in Health or Science Class
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Serious game trainingA serious game featuring a dramatic/realistic film, pauses with questions for active learning, and practice administration of naloxone and performing CPR | Other | Serious Game |
Primary outcome
Naloxone administration Skill
Time frame: Day of training, and 2-3 months
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.
3 secondary outcomes
CPR Skill
Time frame: Day of training, and 2-3 months
Attitudes towards opioid overdose
Time frame: Day of training, and 2-3 months
Knowledge of opioid overdose response
Time frame: Day of training, and 2-3 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 11 Dec 2024.
- Individual participant dataSharing planned: No. Participants are minors and therefore protected. No IDP will be shared
Related trials for Opioid Overdose
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PATH to Reducing Burnout Among Peers Who Deliver Overdose Prevention Services (R33 Phase Clinical Trial)
Burnout, Secondary Trauma
Active, not recruiting
Improving Access to Naloxone to Prevent Opioid Overdose Deaths (SAIA-Naloxone)
Overdose, Implementation as Usual
Recruiting
Improving Jail Response to the Overdose Crisis: A Hybrid Trial of Jail ECHO to Improve MOUD Implementation and Public Health Outcomes
Opioid Abuse (Disorder)
Not yet recruiting
Remote vs. In-Person Study Evaluation (RISE) Trials: RISE Above Opioid Overdose (Trial 3 of 3)
Remote vs. In-Person, Remote Visits
Recruiting
The ENHANCE Project Toolkit
Substance Related Disorder, Drug Overdose
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Serious game training in people with Opioid Overdose, run by University of Nevada, Reno.
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: opening soon, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Associate Professor, MD (7756828239, ltoft@unr.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Naloxone administration Skill (time frame: Day of training, and 2-3 months). 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 11 Dec 2024.