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Behavioral Intervention

PlaySmart Digital Intervention for Preventing Adolescent Opioid Abuse

N/A

Waitlist Available

Led By Lynn E Fiellin, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 weeks, 3, 6, and 12 months

Awards & highlights

Study Summary

This trial is testing if an intervention can help reduce the risk of harm from opioids.

Who is the study for?

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).Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves playing a digital game as an intervention, there are no direct medical side effects expected. However, participants may experience fatigue or eye strain from screen time.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 weeks, 3, 6, and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 weeks, 3, 6, and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks, 3, 6, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Perception of Risk

Secondary outcome measures

Beliefs About Psychological Services (p2P Lab Questions)

Change in Attitudes to Misuse Opioids (p2P Lab Questions)

Change in Intentions to Misuse Opioids (p2P Lab Questions)

+22 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: PlaySmartExperimental Treatment1 Intervention

Video game intervention.

Group II: Control GameExperimental Treatment1 Intervention

Control video game intervention.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PlaySmart

2021

N/A

~40

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,847 Previous Clinical Trials

2,737,135 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,465 Previous Clinical Trials

2,618,100 Total Patients Enrolled

16 Trials studying Opioid Abuse

338,788 Patients Enrolled for Opioid Abuse

Lynn E Fiellin, MDPrincipal InvestigatorDirector, Yale Center for Health & Learning Games, Internal Medicine; Director, play2PREVENT Lab at Yale, Internal Medicine

5 Previous Clinical Trials

684 Total Patients Enrolled

Media Library

PlaySmart (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04941950 — N/A

Opioid Abuse Research Study Groups: Control Game, PlaySmart

Opioid Abuse Clinical Trial 2023: PlaySmart Highlights & Side Effects. Trial Name: NCT04941950 — N/A

PlaySmart (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04941950 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What qualifications must potential trial participants meet?

"This trial is set to recruit 532 adolescents aged 16-19 with a current opioid usage. Furthermore, they must be enrolled in their respective high school's School-Based Health Center and not have any history of opioid misuse. Additionally, the candidate must exhibit "high-risk" behaviour based on past 30 day use of various drugs or score above 1 on either the PHQ-2 or GAD-2 screening tool used by SBHA. Lastly, it is mandatory for them to commit an hour each session dedicated solely towards playing the game as well as providing assent/parental/guardian consent (if under age 18)."

Answered by AI

What is the participant capacity of this clinical trial?

"Affirmative. The clinicaltrials.gov website attests that this medical trial is presently in search of patients; the study was initially made available on October 19th 2021 and its details were last updated on June 14th 2022. This research requires 532 participants from a single facility to take part."

Answered by AI

Does this research study have any age limitations for its participants?

"This research study is specifically seeking participants aged 16-19. Meanwhile, there are 22 other medical studies for under 18s and 240 trials targeting individuals over 65 years of age."

Answered by AI

Are any openings currently available in this clinical investigation?

"Affirmative, the clinicaltrials.gov database shows that this medical experimentation is currently enrolling test subjects. The trial was inaugurated on October 19th 2021 and most recently updated June 14th 2022. Approximately 532 patients require recruitment from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Randomized Controlled Trial: A Digital Intervention to Prevent the Initiation of Opioid Misuse in Adolescents in School-based Health Centers

2021. "Randomized Controlled Trial: A Digital Intervention to Prevent the Initiation of Opioid Misuse in Adolescents in School-based Health Centers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04941950.