N/A
N=533
A Digital Intervention to Prevent the Initiation of Opioid Misuse in Adolescents in School-based Health Centers
Opioid Misuse
Bottom Line
View on ClinicalTrials.gov: NCT04941950 ↗Enrolled (actual)
533
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Percentage Reporting 'Great Perceived Risk of Harm' From Opioid Misuse — 66; 53 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PlaySmart (Behavioral); Video Game Control (Other)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- All
- Sponsor
- Trustees of Dartmouth College
- Primary completion
- Mar 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Reporting 'Great Perceived Risk of Harm' From Opioid Misuse |
66; 53 | — |
| SECONDARY Intentions to Misuse Opioids (p2P Lab Questions) |
2.7; 2.6; 2.6; 2.7; 2.5; 2.5 | — |
| SECONDARY Self Efficacy for Refusing Opioids (p2P Lab Questions) |
9.2; 9.3; 9.1; 9.1; 9.1; 9.3 | — |
| SECONDARY Knowledge About Opioid Misuse and Its Risks (p2P Lab Questions) |
24.4; 24.8; 26.6; 24.4; 26.4; 24.9 | — |
| SECONDARY Positive Attitudes Toward Opioid Misuse (p2P Lab Questions) |
10.3; 10.9; 10.1; 10.3; 9.7; 10.6 | — |
| SECONDARY Negative Attitudes Toward Opioid Misuse (p2P Lab Questions) |
16.5; 17.7; 18.7; 17.8; 18.7; 18.8 | — |
Summary
The primary hypothesis of this study is that at 3 months, there will be a higher proportion of intervention participants vs. control participants who report greater risk of harm from misuse of prescription opioids AND heroin.
Eligibility Criteria
Inclusion Criteria
- Participants must:
- 1) preferably be enrolled in their high school's School-Based Health Center;
- 2) report NOT having engaged in any prior opioid misuse;
- 3) be at "high-risk" based on their report at baseline of past 30-day use of cigarettes, e-cigarettes, Juul, alcohol, marijuana (including synthetics), amphetamine, cocaine, benzodiazepines, ecstasy, bath salts, or any other misuse of non-opioid prescription drugs or use of non-opioid illicit drugs OR have a score of ≥1 on the PHQ-2 OR a score of ≥1 on the GAD-2 (both screening tools used by SBHA);
- 4) be willing to sit for 60 minutes/session to play the game;
- 5) be able to provide assent/parental/guardian consent (if under age 18).
Exclusion Criteria
- Failure to meet any of the inclusion criteria.
Data sourced from ClinicalTrials.gov (NCT04941950). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.