Youth Engagement Strategy for Opioid Use Disorder

Overseen By Taylor Arnold

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: High youth engagement, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a Youth Engagement strategy to prevent opioid misuse by involving young people in community-based prevention efforts. The first phase will develop and test this strategy with one organization to assess its effectiveness and practicality. The second phase will compare four organizations, with some using the strategy and others not, to determine its impact on preventing opioid misuse. Organizations focused on preventing opioid misuse and ready to involve youth in their efforts are well-suited for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative prevention strategies that could significantly impact community health.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the Youth Engagement prevention strategy is safe for opioid misuse prevention?

Research has shown that the Youth Engagement (YE) prevention strategy is generally safe. This approach includes activities that help young people learn skills to avoid starting substance use, such as using opioids. Studies have found that youth-focused programs can reduce the number of young people who begin using substances.

These strategies are well-received and aim to encourage positive behaviors. Available data reports no negative effects from these programs. The goal is to involve young people in ways that benefit them, their organizations, and their communities, indicating a high level of safety for participants in similar programs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to tackle opioid use disorder in young people by actively involving them in prevention strategies. Unlike traditional methods that often focus on drug therapies or counseling alone, this approach integrates youth engagement directly into community prevention efforts. By empowering young people to participate in the design and implementation of these strategies, the trial aims to enhance the effectiveness of prevention programs and potentially reduce the incidence of opioid misuse. This proactive involvement could lead to more relevant and impactful prevention measures that resonate with young individuals, offering a fresh perspective in the fight against opioid addiction.

What evidence suggests that the Youth Engagement prevention strategy is effective for opioid use disorder?

Research has shown that involving young people in prevention efforts can help reduce substance misuse, including opioids. School programs that teach important skills have successfully prevented substance use before it begins. Studies indicate that youth-focused programs can decrease the number of young people who start using drugs. In this trial, the intervention group will implement the Youth Engagement strategy, aiming to enhance program effectiveness by directly involving young people in prevention efforts. Engaging youth allows organizations to better design programs that address the needs and challenges young people face, potentially reducing opioid misuse. ^{1 2 5 6 7}

Who Is on the Research Team?

Parissa J. Ballard, PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for leaders or staff of North Carolina-based community organizations focused on opioid misuse prevention. These organizations should be ready and interested in incorporating Youth Engagement (YE) strategies, with the necessary resources to do so. Participants must speak English fluently. It also includes volunteers aged 16-29 engaged in these efforts. Organizations already highly involved in YE are excluded.

Inclusion Criteria

Engaged as volunteers with the organization's opioid misuse prevention efforts

Able to speak and read English fluently

Organizational leaders/staff: Leaders or staff of community-based prevention organizations based in North Carolina

Exclusion Criteria

My organization highly involves youth in its prevention efforts.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Open Trial

Development and implementation of an organization-level Youth Engagement prevention strategy in a community-based organization to test feasibility and acceptability.

6-9 months

Phase 2: Randomized Controlled Trial

Four organizations are randomized to include or exclude Youth Engagement in prevention efforts to evaluate the preliminary effectiveness of YE as a prevention strategy for opioid misuse.

12-18 months

Follow-up

Participants are monitored for changes in self-efficacy, social connectedness, and other individual-level outcomes after the intervention.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Organization-level Youth Engagement prevention strategy

Trial Overview The study tests a new strategy that involves youth more deeply in substance misuse prevention programs within community organizations. Phase 1 develops and tests this approach's feasibility; Phase 2 uses a small-scale randomized controlled trial to compare outcomes between groups using the YE strategy and those not using it.

How Is the Trial Designed?

Group I: Intervention group Experimental Treatment 1 Intervention

In this arm the study will implement an organization-level Youth Engagement prevention strategy by systematically incorporating Youth Engagement into prevention efforts in a community setting. Youth (individuals) participating in the intervention organizations' programming following the organization's completion of the YE intervention will complete surveys.

Group II: Control group Active Control 1 Intervention

This arm will receive no intervention. Control group organizations will continue their normal prevention strategy without the inclusion of a Youth Engagement component

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

Buprenorphine is a promising treatment for adolescents and young adults with opioid use disorders (OUD), supported by three randomized controlled trials and multiple observational studies, highlighting its potential effectiveness in this population.

The review suggests that OUD in youth should be treated as a chronic medical condition, advocating for long-term management strategies that include buprenorphine without the need for daily clinic visits, although further research is needed to optimize treatment delivery and adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buprenorphine Treatment for Adolescents and Young Adults With Opioid Use Disorders: A Narrative Review. Borodovsky, JT., Levy, S., Fishman, M., et al.[2019]

A scoping review of 30 articles identified 14 actionable strategies that enhance patient engagement in outpatient care for opioid use disorder (OUD), emphasizing the importance of patient-centered care.

Interpersonal interactions between patients and providers were found to be crucial for fostering engagement during OUD treatment, highlighting the need for further research on effective engagement strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and Provider Perspectives on Processes of Engagement in Outpatient Treatment for Opioid Use Disorder: A Scoping Review. Austin, EJ., O'Brien, QE., Ruiz, MS., et al.[2023]

In a study of 23 youths aged 12-24 with opioid use disorder (OUD) at a youth-specific treatment program, 83% initiated opioid agonist treatment (OAT) with medications like buprenorphine/naloxone, indicating a successful engagement in treatment.

Among those who started OAT, 42.1% achieved stability in their treatment, highlighting the need for ongoing support and tailored approaches to improve long-term outcomes for young individuals with OUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Informing youth-centred opioid agonist treatment: Findings from a retrospective chart review of youths' characteristics and patterns of opioid agonist treatment engagement in a novel integrated youth services program. McInerney, K., Marchand, K., Buckley, J., et al.[2023]

A qualitative study involving interviews with 16 stakeholders from an outpatient addiction medicine program revealed that integrating comprehensive healthcare services and adopting a harm reduction approach significantly enhance patient engagement in medications for opioid use disorder (MOUD).

Key barriers to engagement included stigma and lack of knowledge about addiction among healthcare providers, while supportive services like psychosocial care and telemedicine were identified as crucial for improving retention in MOUD programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical stakeholders' perceptions of patient engagement in outpatient medication treatment for opioid use disorder: A qualitative study. Poulsen, MN., Roe, SA., Asdell, PB., et al.[2023]

Early interventions targeting middle-school students have shown promise in significantly reducing prescription opioid misuse, highlighting the importance of addressing risk factors in youth to prevent future substance use disorders.

There is a need for continued research and development of prevention strategies for adults, particularly those at risk of transitioning from prescription opioids to illicit use, to effectively combat the ongoing opioid crisis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting Youth to Prevent Later Substance Use Disorder: An Underutilized Response to the US Opioid Crisis. Compton, WM., Jones, CM., Baldwin, GT., et al.[2023]

In a study of 152 youth with opioid use disorder, those receiving 12 weeks of Bup/Nal treatment attended significantly more therapy sessions and showed less opioid use compared to those who underwent a shorter detoxification treatment.

The results suggest that a higher number of therapy sessions (therapy dose) is linked to better outcomes, indicating that extended Bup/Nal treatment may promote abstinence by enhancing the therapeutic experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapy Dose Mediates the Relationship Between Buprenorphine/Naloxone and Opioid Treatment Outcomes in Youth Receiving Medication for Opioid Use Disorder Treatment. Hammond, CJ., Kady, A., Park, G., et al.[2023]

A prediction model for identifying youth at risk of opioid use disorder (OUD) was developed using data from 76,603 individuals, successfully identifying 57-88% of future OUD diagnoses based on factors like smoking status and mental health.

Despite good discrimination in predicting OUD, the model's positive predictive value was low (<1%), indicating that broad prevention strategies may be more effective than targeted interventions for youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and validation of a prediction model for opioid use disorder among youth. Wagner, NM., Binswanger, IA., Shetterly, SM., et al.[2023]

Pediatricians play a crucial role in addressing the opioid crisis among adolescents by identifying early opioid use, preventing escalation, and providing effective treatments, including medications like naltrexone and buprenorphine.

Implementing brief interventions and overdose education during medical visits for youth who use opioids can significantly reduce the risk of opioid-related mortality and complications, highlighting the importance of integrating opioid use disorder treatment into primary care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Opioid Misuse and Opioid Use Disorders Among Youth. Robinson, CA., Wilson, JD.[2021]

A survey of 497 substance use disorder treatment workers in the USA and UK revealed that personality disorders, low motivation to change, and social problems are the primary barriers to treatment retention for individuals with opioid use disorder (OUD).

The study highlighted regional differences in treatment approaches, with UK providers favoring behavioral treatments, while US providers more frequently utilized objective measures like urine analysis to assess retention, indicating a need for tailored training for treatment staff.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obstacles to treatment retention in opioid use disorder: An international substance use disorder treatment worker survey. Jones, M., Guirguis, A., Watkins, A., et al.[2023]

Citations

1. cdc.gov cdc.gov/overdose-prevention/media/pdfs/2025/08/ENGAGE_Resource-for-Action_508c.pdf

Evidence-Based Strategies to Prevent Youth Substance Use This strategy includes school-based interventions that develop youth skills to prevent substance use initiation and to engage in healthy behaviors. Approach.

2. clinicaltrial.be clinicaltrial.be/nl/details/258867?per_page=100&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Organization-level Youth Engagement Approach for ... The survey items will ask about perceived usefulness of the YE intervention for youth/young adults, the organization, and the community. Items will be on a 1-5 ...

3. naco.org naco.org/resource/osc-youth-prevention

Youth-Focused Prevention: A NACo Opioid Solutions ... Youth-focused programs can help counties achieve a variety of goals, including reducing the number of youth who begin using substances.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S294987592400064X

Engagement, initiation, and retention in medication ... This narrative review summarizes barriers to OUD treatment faced by YAs in the US and strategies to overcome them, and proposes a research and clinical agenda.

5. reporter.nih.gov reporter.nih.gov/project-details/8249504

Ehancing Prevention Capacity with Developmental Assets ... Youth Engagement: An Organization-Level Strategy to Prevent Opioid Misuse among Young Adults ... opioid use disorder treatment and HIV prevention and care ...

6. cdc.gov cdc.gov/overdose-prevention/php/interventions/youth-substance-use-prevention.html

Evidence-Based Strategies to Prevent Youth Substance Use Six strategies to prevent or delay youth substance use initiation; Approaches for each strategy that can be tailored to address the specific ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6595524/

Targeting Youth to Prevent Later Substance Use Disorder These include reducing opioid overprescribing and curtailing the supply of illicit opioids, overdose rescue interventions, and treatment and recovery support ...