PlaySmart Digital Intervention for Preventing Adolescent Opioid Abuse

No longer recruiting at 14 trial locations

Overseen By Lily Hoerner

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Trustees of Dartmouth College

Disqualifiers: Opioid misuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a video game called PlaySmart can help teenagers understand the risks of misusing opioids, such as prescription painkillers and heroin. Participants will either play the PlaySmart game or a different control game to compare effects. Teens who haven't misused opioids but are considered "high-risk" due to other substance use or certain mental health indicators might be suitable candidates. The goal is to assess whether PlaySmart can increase awareness of the dangers of opioid misuse. As an unphased trial, this study provides a unique opportunity for teens to contribute to innovative research that could shape future prevention strategies.

Do I have to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the PlaySmart digital intervention is safe for adolescents?

Research shows that PlaySmart, a digital game, helps prevent opioid misuse among teenagers. Studies have not identified any safety issues with this type of game. As PlaySmart is a video game, it does not involve taking medicine, making it generally safer than drug-based treatments. Previous studies have found no negative effects, suggesting that users receive the game well. So far, PlaySmart appears safe for teenagers aiming to avoid opioid misuse. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about PlaySmart because it offers a fresh, digital approach to preventing adolescent opioid abuse. Unlike traditional treatments that often rely on counseling or medication, PlaySmart uses an engaging video game to educate and prevent misuse. This innovative method has the potential to reach teens in a familiar and interactive way, making the learning process more relatable and effective.

What evidence suggests that the PlaySmart intervention is effective for preventing adolescent opioid abuse?

Research shows that PlaySmart, a digital health game, could help prevent opioid misuse among teenagers. In this trial, some participants will engage with PlaySmart, while others will use a control video game. Studies have found that teens who play PlaySmart become more aware of the risks of using opioids. Early results suggest that this video game effectively supports mental health by teaching teens about the dangers of prescription painkillers and heroin. These findings highlight PlaySmart's potential as a tool to tackle opioid misuse and support teen mental health. ^{1 2 3 6 7}

Who Is on the Research Team?

Lynn E Fiellin, MD

Principal Investigator

Director, play2PREVENT Lab & Professor, BDS at Geisel School of Medicine at Dartmouth College

Are You a Good Fit for This Trial?

This trial is for high school students who have not misused opioids but are considered 'high-risk' due to recent use of substances like alcohol, marijuana, or non-opioid drugs. They must be willing to play a game for an hour per session and can give consent (or have it given by a parent/guardian if under 18).

Inclusion Criteria

Participants must preferably be enrolled in their high school's School-Based Health Center

1) preferably be enrolled in their high school's School-Based Health Center;

Participants must report NOT having engaged in any prior opioid misuse

Exclusion Criteria

Failure to meet any of the inclusion criteria.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in the PlaySmart or control video game intervention

6 weeks

Regular gameplay sessions

Follow-up

Participants are monitored for changes in perception of risk, intentions to misuse opioids, and self-efficacy at multiple time points

12 months

Assessments at 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• PlaySmart
• Video Game Control

Trial Overview

The study tests whether the digital intervention PlaySmart can prevent opioid misuse among adolescents compared to a control video game. The effectiveness will be measured after three months based on participants' perceived risk of harm from prescription opioids and heroin/fentanyl.

How Is the Trial Designed?

Group I: PlaySmart Experimental Treatment 1 Intervention

Video game intervention.

Group II: Control Game Experimental Treatment 1 Intervention

Control video game intervention.

Who Is Running the Clinical Trial?

Trustees of Dartmouth College

Lead Sponsor

Trials

32

Recruited

14,500+

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1.

reporter.nih.gov

reporter.nih.gov/project-details/10408897

A digital intervention to prevent the initiation of opioid misuse ...

We hypothesize that participants in the PlaySmart group, compared to the control group, will have improved outcomes at 6 weeks (completion of gameplay), and at ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04109599

A Digital Intervention to Prevent Initiation of Opioid Misuse ...

PlaySmart is a digital intervention targeted towards preventing opioid misuse in older adolescents. Intervention/Treatment, Behavioral : PlaySmart.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10490848/

A digital health game to prevent opioid misuse and ...

A digital health game to prevent opioid misuse and promote mental health in adolescents in school-based health settings.

4.

jahonline.org

jahonline.org/article/S1054-139X(24)00602-5/fulltext

30. A Digital Health Game to Prevent Opioid Misuse and ...

The serious videogame, PlaySmart, was developed to prevent opioid misuse and promote mental health in adolescents.

5.

games.jmir.org

games.jmir.org/2023/1/e46912/

A Video Game Intervention to Prevent Opioid Misuse Among ...

Conclusions: PlaySmart offers a promising digital intervention to address the current opioid and mental health crises among adolescents in a ...

6.

journals.plos.org

journals.plos.org/plosone/article/file?type=printable&id=10.1371/journal.pone.0291298

A digital health game to prevent opioid misuse and promote ...

The PlaySmart formative work incorpo- rated input from adolescents to develop the intervention. There is strong evidence that opioid misuse and ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10656656/

A Video Game Intervention to Prevent Opioid Misuse Among ...

We developed a novel video game PlaySmart for older adolescents that addresses the risk and protective factors for opioid misuse and mental health.