Youth Engagement Strategy for Opioid Use Disorder
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Wake Forest University Health Sciences
Disqualifiers: High youth engagement, others
No Placebo Group
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.
12345How 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.
36789Eligibility 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
+5 more
Exclusion Criteria
My organization highly involves youth in its prevention efforts.
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Phase 2 interventionExperimental Treatment1 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 controlActive Control1 Intervention
This arm will receive no intervention. Control group organizations will continue their normal prevention strategy without the inclusion of a Youth Engagement component
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Wake Forest School of MedicineWinston-Salem, NC
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Who Is Running the Clinical Trial?
Wake Forest University Health SciencesLead Sponsor
National Institute on Drug Abuse (NIDA)Collaborator
References
Buprenorphine Treatment for Adolescents and Young Adults With Opioid Use Disorders: A Narrative Review. [2019]: In the past decade, a new cohort of adolescents and young adults with opioid use disorders (OUD) has emerged. While medications and psychosocial treatments are available, few adolescents and young adults with OUD can access and remain in treatment. Effective, practical, and scalable treatment paradigms for this young population are needed. Buprenorphine is a medication with unique pharmacological and regulatory characteristics that make it a promising component of adolescent and young adult OUD treatment models. Three randomized controlled trials and multiple observational studies have evaluated the use of buprenorphine to treat this population. However, data from these studies have not been consolidated into an up-to-date summary that may be useful to clinicians. The objective of this narrative review is to inform clinical practice by summarizing results of primary and secondary analyses from randomized controlled clinical trials and observational studies that have evaluated the use of buprenorphine to treat adolescents and young adults with OUD. Based on results from these studies, we encourage the conceptualization of OUD among youth as a chronic medical condition requiring a long-term management strategy. This includes treatment with buprenorphine in conjunction with medication-prescribing protocols that do not necessarily require daily clinic attendance for observed medication adherence. However, more study of treatment delivery models, addressing such issues as medication adherence and intensity requirements, is needed to determine practices that optimize outcomes for youth.
Clinical stakeholders' perceptions of patient engagement in outpatient medication treatment for opioid use disorder: A qualitative study. [2023]Medications for opioid use disorder (MOUD) reduce risk of opioid overdose and promote recovery from opioid use disorder, but poor retention in MOUD limits these positive effects. This study explored patient engagement in MOUD from the perspective of clinical stakeholders within an outpatient addiction medicine program to identify program factors influencing patient engagement with treatment.
Management of Opioid Misuse and Opioid Use Disorders Among Youth. [2021]In response to the growing impact of the current opioid public health crisis in the United States on adolescents and young adults, pediatricians have an expanding role in identifying opioid use early, preventing escalation of risky use, reducing opioid-related harms, and delivering effective therapies. Research and expert consensus suggest the use of brief interventions focused on reducing risks associated with ongoing opioid use and using motivational interviewing strategies to engage youth in treatment. Because fatal opioid overdose remains a major cause of opioid-related mortality among youth, delivering overdose education as part of any visit in which a youth endorses opioid use is one evidence-based strategy to decrease the burden of opioid-related mortality. For youth that are injecting opioids, safe injection practices and linkage to needle or syringe exchanges should be considered to reduce complications from injection drug use. It is crucial that youth be offered treatment at the time of diagnosis of an opioid use disorder (OUD), including medications, behavioral interventions, and/or referral to mutual support groups. The 2 medications commonly used for office-based OUD treatment in adolescents are extended-release naltrexone (opioid antagonist) and buprenorphine (partial opioid agonist), although there is a significant treatment gap in prescribing these medications to youth, especially adolescents
Patient and Provider Perspectives on Processes of Engagement in Outpatient Treatment for Opioid Use Disorder: A Scoping Review. [2023]Effective treatment for opioid use disorder (OUD) is available, but patient engagement is central to achieving care outcomes. We conducted a scoping review to describe patient and provider-reported strategies that may contribute to patient engagement in outpatient OUD care delivery. We searched PubMed and Scopus for articles reporting patient and/or provider experiences with outpatient OUD care delivery. Analysis included: (1) describing specific engagement strategies, (2) mapping strategies to patient-centered care domains, and (3) identifying themes that characterize the relationship between engagement and patient-centered care. Of 3,222 articles screened, 30 articles met inclusion criteria. Analysis identified 14 actionable strategies that facilitate patient engagement and map to all patient-centered care domains. Seven themes emerged that characterize interpersonal approaches to OUD care engagement. Interpersonal interactions between patients and providers play a pivotal role in encouraging engagement throughout OUD treatment. Future research is needed to further evaluate promising engagement strategies.
Obstacles to treatment retention in opioid use disorder: An international substance use disorder treatment worker survey. [2023]Treatment retention is associated with better outcomes and reduced risk amongst people experiencing opioid use disorder (OUD). Despite this, treatment retention remains low amongst this population.
Targeting Youth to Prevent Later Substance Use Disorder: An Underutilized Response to the US Opioid Crisis. [2023]The evolving US opioid crisis is complex and requires myriad different interventions. These include reducing opioid overprescribing and curtailing the supply of illicit opioids, overdose rescue interventions, and treatment and recovery support services for those with opioid use disorders. To date, more distal primary prevention strategies that have an evidence base are underutilized. Yet, the impact of early environments on later substance use disorder risk is increasingly well understood, including knowledge of the mechanistic linkages between brain development and subsequent risk behaviors. Applying this developmental framework to prevention shows promise, and some middle-school interventions have demonstrated significant reductions in prescription opioid misuse. Reducing these risks of initial misuse of opioids may be the "ounce of prevention" that makes a substantial difference in a society now reeling from the worst drug crisis our country has seen. The challenge is to continue to develop and test promising distal interventions and to support implementation fidelity through frameworks that ensure their cultural appropriateness and sustainability. In addition, research is needed to develop new prevention strategies for adults, including patients with pain at risk for transitioning from prescription to illicit opioids.
Therapy Dose Mediates the Relationship Between Buprenorphine/Naloxone and Opioid Treatment Outcomes in Youth Receiving Medication for Opioid Use Disorder Treatment. [2023]Evidence-based interventions for treating opioid use disorder (OUD) in youth are limited and little is known about specific and general mechanisms of OUD treatments and how they promote abstinence.
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]Youth ages 12-24 account for approximately 20% of overdoses and yet are poorly reached by opioid agonist treatment (OAT), the most widely recommended treatment for opioid use disorder (OUD). This study contributes to understanding this critical gap by describing youths' patterns of OAT engagement at a novel integrated youth-specific OAT program.
Development and validation of a prediction model for opioid use disorder among youth. [2023]Youth are vulnerable to opioid use initiation and its complications. With growing rates of opioid overdose, strategies to identify youth at risk of opioid use disorder (OUD) to efficiently focus prevention interventions are needed. This study developed and validated a prediction model of OUD in youth aged 14-18 years.