Opioid MisuseNCT04941950
A Digital Intervention to Prevent the Initiation of Opioid Misuse in Adolescents in School-based Health Centers
A study testing PlaySmart in people with Opioid Misuse, run by Tyra Boomer at 15 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Misuse
- What is being tested?
- PlaySmart
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 533 participants
- Where
- 15 sitesUnited States
- Study dates
- 21 Oct 2021to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- Failure to meet any of the inclusion criteria.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Harding High School
Bridgeport, Connecticut, 06610
Coginchaug High School
Durham, Connecticut, 06422
CT River Academy
East Hartford, Connecticut, 06118
Fairfield College Preparatory School
Fairfield, Connecticut, 06824
Fitch High School
Groton, Connecticut, 06340
Hamden High School
Hamden, Connecticut, 06514
Weaver High School
Hartford, Connecticut, 06112
Maloney High School
Meriden, Connecticut, 06450
Platt High School
Meriden, Connecticut, 06450
Hopkins High School
New Haven, Connecticut, 06515
New London High School
New London, Connecticut, 06320
Stamford High School
Stamford, Connecticut, 06902
Westhill High School
Stamford, Connecticut, 06902
Academy of Information, Technology, and Engineering
Stamford, Connecticut, 06905
West Haven High School
West Haven, Connecticut, 06516
About this study
Official title: A Digital Intervention to Prevent the Initiation of Opioid Misuse in Adolescents in School-based Health Centers (Randomized Controlled Trial)
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.
Read the detailed description
This study's specific aims are to:
Conduct a randomized controlled trial with 532 high-risk adolescents in 10 School Based Health Centers (SBHCs), to compare PlaySmart to attention/time control games, with assessments post- gameplay (6 weeks), and at 3, 6, and 12 months following enrollment to determine if PlaySmart: 1) increases proportion of participants who report a perception of great risk of harm from misuse of opioids at 3 months; and 2) decreases intentions to misuse opioids; 3) increases self-efficacy for refusing opioids; 4) prevents initiation of opioid misuse, at all time-points.
- Conditions
- Opioid Misuse
- Being tested
- PlaySmart, Video Game Control
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaySmartBehavioural
PlaySmart is designed to provide players with behavioral skills and knowledge through repetitive and engaging videogame play to target adolescent perception of risk of harm from initiating opioid misuse.
Video Game ControlOther
Participants in the control group will play another video game with no intended effect similar to PlaySmart.
| Study group | Role | What they receive |
|---|---|---|
| PlaySmart | Experimental | Video game intervention. Receives: Behavioral: PlaySmart |
| Control Game | Other | Control video game intervention. Receives: Other: Video Game Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Reporting 'Great Perceived Risk of Harm' From Opioid Misuse
Perceived risk of harm from opioid misuse was assessed using eight items adapted from the U.S. Monitoring the Future survey. Five items assess perceived risk associated with heroin use and three items assess perceived risk associated with prescription opioid misuse. Participants were asked how much risk people have of harming themselves (physically or in other ways) if they use the drug once or twice, occasionally, or regularly. Response options were "no risk," "slight risk," "moderate risk," "great risk," and "can't say, drug unfamiliar."
Items were scored from 1 to 4 (no risk = 1, slight risk = 2, moderate risk = 3, great risk = 4). Item scores were summed to create a total perceived risk score (range 8-32), with scores <32 indicating "no great perceived risk of harm" and scores=32 indicating "great perceived risk of harm."
The primary outcome was defined as the percentage of participants who reported "great perceived risk of harm" from opioids (score=32) at 3 months.
Measured: 3 months
Secondary outcomes (5)
Intentions to Misuse Opioids (p2P Lab Questions)
Intentions to misuse opioids were assessed using 2-4 items adapted from Skenderian et. al. capturing participants' likelihood of using prescription opioids or heroin in the next 12 months. Two primary stem questions assessed likelihood of using (1) prescription opioids and (2) heroin "even once or time." For each substance, if participants endorsed any likelihood of use, a follow-up item assessed likelihood of using the same substance nearly every month for the next 12 months. Due to skip logic, participants who selected "definitely not" on the initial stem questions were not shown follow-up items.
All items were rated on a 4-point Likert scale ranging from 1 (definitely not) to 4 (definitely will). Item responses were summed to create a total intentions score ranging from 2 to 16, with lower scores indicating lower intentions to misuse opioids.
LS mean scores were estimated using mixed-effects models at each timepoint.
Measured: Baseline, 6 weeks, 3, 6, and 12 months
Self Efficacy for Refusing Opioids (p2P Lab Questions)
Self-efficacy for refusing opioids was assessed using a two-item scale measuring participant's confidence in refusing prescription opioids or heroin if offered by a friend, adult or family member. Reponses were scored on a five-point scale ranging from 1 ("Not at all confident") to 5 ("Extremely confident") and summed across items to create a total score (range = 2-10), with higher scores indicating greater self-efficacy to refuse opioids.
LS mean scores were estimated using mixed-effects models at each timepoint.
Measured: Baseline, 6 weeks, 3, 6, and 12 months
Knowledge About Opioid Misuse and Its Risks (p2P Lab Questions)
Knowledge about opioids was assessed using a 30-item questionnaire measuring participants' understanding of opioid misuse and its risks. Each of the first 27 items was scored 1 point for a correct answer. The final 3 items were multiple-choice 'select all that apply' questions; participants received 1 point for each correct option selected. Total scores ranged from 0 to 38, with higher scores indicating greater knowledge about opioids.
LS mean scores were estimated using mixed-effects models at each timepoint.
Measured: Baseline, 6 weeks, 3, 6, and 12 months
Positive Attitudes Toward Opioid Misuse (p2P Lab Questions)
Attitudes about opioid use were assessed using a 15-item scale measuring positive and negative expectancies about using prescription opioids or heroin. Participants rated their agreement with statements such as "If I used prescription opioids or heroin, I would feel good" (positive expectancies) or "I would get in trouble with my parents" (negative expectancies) on a five-point scale from 0 ("Strongly disagree") to 4 ("Strongly agree").
Item scores were summed separately for positive and negative expectancies. The first 8 items represented positive expectancies (score range = 0-32). Higher scores indicate stronger expectancies. For positive expectancies, the goal of the intervention is to reduce scores.
LS mean scores were estimated using mixed-effects models at each timepoint.
Measured: Baseline, 6 weeks, 3, 6, and 12 months
Negative Attitudes Toward Opioid Misuse (p2P Lab Questions)
Attitudes about opioid use were assessed using a 15-item scale measuring positive and negative expectancies about using prescription opioids or heroin. Participants rated their agreement with statements such as "If I used prescription opioids or heroin, I would feel good" (positive expectancies) or "I would get in trouble with my parents" (negative expectancies) on a five-point scale from 0 ("Strongly disagree") to 4 ("Strongly agree").
Item scores were summed separately for positive and negative expectancies. The last 7 items represented negative expectancies (score range = 0-28). Higher scores indicate stronger expectancies. For negative expectancies, the goal is to increase scores.
LS mean scores were estimated using mixed-effects models at each timepoint.
Measured: Baseline, 6 weeks, 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start21 Oct 2021
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Opioid MisuseStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 533 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tyra Boomer
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Tyra Boomer, Trustees of Dartmouth College
- Investigators
- Lynn E Fiellin, MD, Principal investigator, Director, play2PREVENT Lab & Professor, BDS at Geisel School of Medicine at Dartmouth College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04941950
- Sponsor's protocol ID
- 2000030553
- Other IDs
- 1UG3DA050251-01
- Status last verified
- May 2026
- First submitted
- 23 Jun 2021
- Last updated
- 1 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The plan will comply with the NIH HEAL Initiative ClinicalTrials.govSM Public Access and Data Sharing Policy, NIH Data Sharing Policy, NIH Policy on Dissemination of NIH-Funded Clinical Trial Information, and NIH Clinical Trial Registration and Results Information Submission rule. All IPD will be in a repository supported by NIDA, the NAHDAP, following NIH requirements for sharing data via creation of public-use data sets. Data will be de-identified/masked to minimize risk of potential re-identification to participants. This may include modification of the original data to reduce risk of re-identification of participants. A structured process will evaluate the risk of re-identification based on guidance documents from the US DHHS, HIPAA, and quantitative evaluation of the data using statistical methods. Potential revisions to the data to prepare them for NAHDAP include omission of variables, collapsing of categories of a variable, or other coarsening of specific participants' values.
Publications
Barry CM, Boomer T, Haile K, Xie H, Fiellin LE. A Digital Behavioral Health Game for Adolescent Mental Health: A Prespecified Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2026 Aug 3;9(8):e2629173. doi: 10.1001/jamanetworkopen.2026.29173.
PubMed 42606863Boomer T, Hoerner L, Larkin K, Maciejewski K, Kyriakides TC, Fiellin LE. A videogame for perceived risk of harm from opioid misuse in adolescents: a randomized controlled trial. Nat Health. 2026;1(1):78-89. doi: 10.1038/s44360-025-00010-z. Epub 2025 Dec 1.
PubMed 41635738Pendergrass Boomer TM, Hoerner LA, Fernandes CF, Maslar A, Aiudi S, Kyriakides TC, Fiellin LE. A digital health game to prevent opioid misuse and promote mental health in adolescents in school-based health settings: Protocol for the PlaySmart game randomized controlled trial. PLoS One. 2023 Sep 8;18(9):e0291298. doi: 10.1371/journal.pone.0291298. eCollection 2023.
PubMed 37683047
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Digital Intervention to Prevent the Initiation of Opioid Misuse in Adolescents in School-based Health Centers (Randomized Controlled Trial)
- ClinicalTrials.gov ID
- NCT04941950
- Acronym / sponsor ID
- 2000030553
- Conditions
- Opioid Misuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 533 participants (actual)
- Lead sponsor
- Tyra BoomerUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 28 Jun 2021 (actual)
- Results
- Posted 24 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study's specific aims are to:
Conduct a randomized controlled trial with 532 high-risk adolescents in 10 School Based Health Centers (SBHCs), to compare PlaySmart to attention/time control games, with assessments post- gameplay (6 weeks), and at 3, 6, and 12 months following enrollment to determine if PlaySmart: 1) increases proportion of participants who report a perception of great risk of harm from misuse of opioids at 3 months; and 2) decreases intentions to misuse opioids; 3) increases self-efficacy for refusing opioids; 4) prevents initiation of opioid misuse, at all time-points.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PlaySmart | Experimental | Behavioral: PlaySmartVideo game intervention. |
| Control Game | Other | Other: Video Game ControlControl video game intervention. |
Who may qualify
- Ages
- 16 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (1 listed)
- Failure to meet any of the inclusion criteria.
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 |
|---|---|---|
| PlaySmartPlaySmart is designed to provide players with behavioral skills and knowledge through repetitive and engaging videogame play to target adolescent perception of risk of harm from initiating opioid misuse. | Behavioural | PlaySmart |
| Video Game ControlParticipants in the control group will play another video game with no intended effect similar to PlaySmart. | Other | Control Game |
Primary outcome
Percentage Reporting 'Great Perceived Risk of Harm' From Opioid Misuse
Time frame: 3 months
Perceived risk of harm from opioid misuse was assessed using eight items adapted from the U.S. Monitoring the Future survey. Five items assess perceived risk associated with heroin use and three items assess perceived risk associated with prescription opioid misuse. Participants were asked how much risk people have of harming themselves (physically or in other ways) if they use the drug once or twice, occasionally, or regularly. Response options were "no risk," "slight risk," "moderate risk," "great risk," and "can't say, drug unfamiliar." Items were scored from 1 to 4 (no risk = 1, slight risk = 2, moderate risk = 3, great risk = 4). Item scores were summed to create a total perceived risk score (range 8-32), with scores <32 indicating "no great perceived risk of harm" and scores=32 indicating "great perceived risk of harm." The primary outcome was defined as the percentage of participants who reported "great perceived risk of harm" from opioids (score=32) at 3 months.
5 secondary outcomes
Intentions to Misuse Opioids (p2P Lab Questions)
Time frame: Baseline, 6 weeks, 3, 6, and 12 months
Self Efficacy for Refusing Opioids (p2P Lab Questions)
Time frame: Baseline, 6 weeks, 3, 6, and 12 months
Knowledge About Opioid Misuse and Its Risks (p2P Lab Questions)
Time frame: Baseline, 6 weeks, 3, 6, and 12 months
Positive Attitudes Toward Opioid Misuse (p2P Lab Questions)
Time frame: Baseline, 6 weeks, 3, 6, and 12 months
Negative Attitudes Toward Opioid Misuse (p2P Lab Questions)
Time frame: Baseline, 6 weeks, 3, 6, and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42606863Barry CM, Boomer T, Haile K, Xie H, Fiellin LE. A Digital Behavioral Health Game for Adolescent Mental Health: A Prespecified Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2026 Aug 3;9(8):e2629173. doi: 10.1001/jamanetworkopen.2026.29173.
- Derived from this study: PubMed 41635738Boomer T, Hoerner L, Larkin K, Maciejewski K, Kyriakides TC, Fiellin LE. A videogame for perceived risk of harm from opioid misuse in adolescents: a randomized controlled trial. Nat Health. 2026;1(1):78-89. doi: 10.1038/s44360-025-00010-z. Epub 2025 Dec 1.
- Derived from this study: PubMed 37683047Pendergrass Boomer TM, Hoerner LA, Fernandes CF, Maslar A, Aiudi S, Kyriakides TC, Fiellin LE. A digital health game to prevent opioid misuse and promote mental health in adolescents in school-based health settings: Protocol for the PlaySmart game randomized controlled trial. PLoS One. 2023 Sep 8;18(9):e0291298. doi: 10.1371/journal.pone.0291298. eCollection 2023.
- Individual participant dataSharing planned: Yes. The plan will comply with the NIH HEAL Initiative ClinicalTrials.govSM Public Access and Data Sharing Policy, NIH Data Sharing Policy, NIH Policy on Dissemination of NIH-Funded Clinical Trial Information, and NIH Clinical Trial Registration and Results Information Submission rule. All IPD will be in a repository supported by NIDA, the NAHDAP, following NIH requirements for sharing data via creation of public-use data sets. Data will be de-identified/masked to minimize risk of potential re-identification to participants. This may include modification of the original data to reduce risk of re-identification of participants. A structured process will evaluate the risk of re-identification based on guidance documents from the US DHHS, HIPAA, and quantitative evaluation of the data using statistical methods. Potential revisions to the data to prepare them for NAHDAP include omission of variables, collapsing of categories of a variable, or other coarsening of specific participants' values.
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Pain Self-Management and Treatment Engagement for Patients Taking Opioids
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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. This study is not recruiting at the moment.
Lynn E Fiellin, MD principal investigator
Director, play2PREVENT Lab & Professor, BDS at Geisel School of Medicine at Dartmouth College
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PlaySmart in people with Opioid Misuse, run by Tyra Boomer at 15 sites in United States.
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 6 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: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Reporting 'Great Perceived Risk of Harm' From Opioid Misuse (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04941950, which also lists 3 linked publications.
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 1 Jul 2026.