What side effects are associated with this type of intervention?

Common treatments for opioid abuse, such as behavioral therapies and medication-assisted treatments (MAT), have various side effects. Behavioral therapies, including cognitive-behavioral therapy (CBT) and psychoeducation, generally have minimal physical side effects but may cause emotional discomfort as patients confront their addiction. MAT, which includes medications like methadone, buprenorphine, and naltrexone, can have side effects such as nausea, constipation, dizziness, and potential dependency on the treatment medication itself. Community-based programs and educational interventions primarily focus on increasing awareness and do not typically have direct physical side effects, but they may cause psychological stress as individuals become more aware of the risks and consequences of opioid misuse.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of opioid abuse, including methadone, buprenorphine, and naltrexone. Methadone and buprenorphine are opioid agonists that help reduce withdrawal symptoms and cravings, while naltrexone is an opioid antagonist that blocks the effects of opioids. These treatments are often used in combination with educational interventions to increase awareness of the risks associated with opioid misuse and to support long-term recovery.

What other types of research exist?

Promising novel alternatives to educational interventions for opioid abuse patients include: 1) Technology-assisted opioid education programs, which provide effective education on opioids and opioid use disorder medications through digital platforms. 2) Opioid helplines, offering resources and live support for individuals at high risk for opioid use disorder. 3) Medically supervised withdrawal protocols using non-opioid medications and opioid antagonists, such as naltrexone, to manage withdrawal symptoms and prevent relapse. 4) App-based pain management programs that deliver opioid safety education and pain management strategies in clinic waiting rooms. These alternatives leverage technology and personalized support to enhance treatment outcomes.

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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

No Placebo-Only Group

Summary

This trial tests if a game called PlaySmart can help high-risk teenagers understand the dangers of misusing prescription opioids and illegal drugs like heroin. The game aims to make them more confident in refusing drugs and prevent them from starting to use these substances.

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).

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Perception of Risk

Perception of Risk

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for opioid abuse include medications like methadone, buprenorphine, and naltrexone. Methadone and buprenorphine are opioid agonists that work by binding to the same receptors in the brain as opioids, reducing cravings and withdrawal symptoms without producing the same high, thus helping patients stabilize and reduce illicit opioid use. Naltrexone is an opioid antagonist that blocks the effects of opioids, preventing any high if the patient relapses. These treatments are crucial as they help manage withdrawal symptoms, reduce cravings, and lower the risk of relapse, thereby supporting recovery and improving the quality of life for patients with opioid use disorder. Educational interventions that increase awareness of the risks associated with opioid misuse can enhance the effectiveness of these treatments by encouraging adherence and informed decision-making.

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Who is running the clinical trial?

Yale UniversityLead Sponsor

1,930 Previous Clinical Trials

3,032,941 Total Patients Enrolled

1 Trials studying Opioid Abuse

240 Patients Enrolled for Opioid Abuse

National Institute on Drug Abuse (NIDA)NIH

2,607 Previous Clinical Trials

3,329,402 Total Patients Enrolled

17 Trials studying Opioid Abuse

369,364 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