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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

Phase 1 will consist of a small pilot Open Trial (OT). The objective of Phase 1 is to develop an organization-level Youth Engagement (YE) prevention strategy and implement it in a community-based organization to test feasibility and acceptability in an open trial with one organization. This will include developing a manual for systematically incorporating YE into prevention efforts in community settings. Phase 2 will consist of a small pilot Randomized Controlled Trial (RCT). Four prevention organizations will be randomized either to include Youth Engagement in prevention efforts (treatment) or not (control). The study team will attempt to match the treatment and control groups on relevant characteristics such as geographic location (e.g., urban, rural), population served (e.g., church-based, school-based), and/or prior Youth Engagement involvement. The objective of the second phase of this study is to evaluate the preliminary effectiveness of YE as a prevention strategy for opioid misuse in a small pilot randomized control trial (RCT). This pilot study will examine the effects of the YE prevention strategy on (a) organization-level outcomes, such as perceived value added to prevention programming and (b) individual-level outcomes such as personal skills and attitudes as well as knowledge and attitudes about substances including opioids. Up to 15 leaders/staff and 45 youth/young adults (60 people overall) will be recruited for the study.

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 data supports the effectiveness of the Youth Engagement Strategy for Opioid Use Disorder treatment?

Research suggests that engaging young people in treatment through strategies like motivational interviewing (a counseling approach to encourage behavior change) and providing education on overdose prevention can help reduce opioid-related harms. Additionally, medications like buprenorphine have shown promise in treating opioid use disorder in adolescents and young adults, indicating that a comprehensive approach combining medication and engagement strategies may be effective. ^{1 2 3 4 5}

How is the Youth Engagement Strategy for Opioid Use Disorder different from other treatments?

The Youth Engagement Strategy for Opioid Use Disorder is unique because it focuses on engaging young people at the organizational level to prevent opioid misuse, rather than just treating the disorder after it develops. This approach emphasizes early intervention and prevention by involving youth in strategies that reduce the risk of opioid use, which is different from traditional treatments that primarily focus on medication and behavioral therapies after diagnosis. ^{3 6 7 8 9}

Research Team

Parissa J. Ballard, PhD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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

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

Able to speak and read English fluently

Organizations are youth/young adult-serving and focused on opioid misuse prevention

Exclusion Criteria

My organization highly involves youth in its prevention efforts.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Phase 2 intervention 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.

Group II: Phase 2 control 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+

Findings from Research

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 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]

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 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]

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]

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]

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 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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Buprenorphine Treatment for Adolescents and Young Adults With Opioid Use Disorders: A Narrative Review. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Clinical stakeholders' perceptions of patient engagement in outpatient medication treatment for opioid use disorder: A qualitative study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Management of Opioid Misuse and Opioid Use Disorders Among Youth. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Patient and Provider Perspectives on Processes of Engagement in Outpatient Treatment for Opioid Use Disorder: A Scoping Review. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Obstacles to treatment retention in opioid use disorder: An international substance use disorder treatment worker survey. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Targeting Youth to Prevent Later Substance Use Disorder: An Underutilized Response to the US Opioid Crisis. [2023]

7. Netherlands 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. [2023]

8. Australia 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. [2023]

9. Ireland pubmed.ncbi.nlm.nih.gov

Development and validation of a prediction model for opioid use disorder among youth. [2023]