Integrated Behavioral Health for Adolescent Opioid Use Disorder

Overseen By Ashley N Vetor, MPH, CCRP

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

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 improve the treatment of substance use disorder (SUD) in adolescents by enhancing support in pediatric primary care settings. Researchers are exploring whether integrated behavioral health approaches with specific SUD resources can facilitate access to effective treatment for young people. Clinics in the study will either implement these integrated health strategies or maintain their usual care routines to compare outcomes. Teens aged 12-18 who use these clinics and have issues with substance use may find this trial relevant.

As an unphased trial, this study offers adolescents the opportunity to contribute to innovative approaches in SUD treatment within primary care settings.

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 this Integrated Behavioral Health System with SUD Resources is safe for adolescents?

Research has shown that combining mental health care with resources for substance use problems can effectively address these issues. However, specific safety information for this combined treatment approach in teenagers with opioid use problems is not available. Generally, integrated care models aim to simplify access to help for mental health and substance use issues. They do not involve new drugs or medical procedures, often making them easier to manage and resulting in fewer side effects compared to medication-based treatments.

In other contexts, these combined approaches have improved patient outcomes, indicating they can be safe and effective. The focus is on providing coordinated care and reducing stigma, creating a supportive environment for young people dealing with these issues. This method is already in use in some healthcare settings for adults and has shown positive results. While detailed safety data for teenagers is lacking, these factors suggest the treatment is considered low-risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to addressing adolescent opioid use disorder by integrating behavioral health systems with specialized substance use disorder (SUD) resources. Unlike traditional methods that often rely solely on medication-assisted treatment or counseling, this approach aims to enhance the connection between young people and necessary substance use treatments within their existing healthcare settings. By embedding SUD resources into regular primary care, the trial seeks to make accessing help easier and more seamless for adolescents, potentially leading to better outcomes in managing opioid use disorder.

What evidence suggests that this Integrated Behavioral Health System with SUD Resources is effective for adolescent opioid use disorder?

This trial will compare an Integrated Behavioral Health System with SUD Resources to standard primary care practice. Research has shown that combining substance use care with regular medical care can greatly help teenagers with substance use disorder (SUD) and opioid use disorder (OUD). Studies have found that an Integrated Behavioral Health (IBH) system can lower overdose rates by encouraging doctors to provide SUD services to teens. A review of research found that outpatient behavioral treatments work well for treating substance use in teenagers. Evidence suggests these programs can make it easier for young people to access treatment, reduce stigma, and lead to better health outcomes. Overall, integrating these resources into clinics appears promising for effectively managing SUD in teenagers. ^{1 2 3 6 7}

Who Is on the Research Team?

Zachary W Adams, PhD

Principal Investigator

Indiana University/Indiana University Health

Matthew C Aalsma, PhD

Principal Investigator

Indiana University/Indiana University Health

Leslie A Hulvershorn, MD

Principal Investigator

Indiana University/Indiana University Health

Are You a Good Fit for This Trial?

This trial is for adolescents at risk of or struggling with substance use disorders (SUD) and opioid use disorder (OUD). It's aimed at improving care within pediatric primary care settings. Participants are likely to be those who regularly visit their pediatricians for annual wellness checks.

Exclusion Criteria

N/A

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Development and Refinement

Development and refinement of primary care-based SUD interventions with input from advisory boards and expert panels

6 months

Regular meetings with advisory boards and expert panels

Implementation

Implementation of Integrated Behavioral Health (IBH) with SUD resources in primary care settings, including stigma-reduction interventions and brief SUD interventions

4 years

Bi-annual data collection visits

Follow-up

Participants are monitored for safety and effectiveness after implementation

1 year

Surveys every six months

What Are the Treatments Tested in This Trial?

Interventions

• Integrated Behavioral Health System with SUD Resources

Trial Overview The study tests an Integrated Behavioral Health System enhanced with SUD resources in pediatric primary care. The goal is to see if this system helps doctors provide better SUD/OUD treatment compared to standard practices, potentially leading to improved health outcomes.

How Is the Trial Designed?

Group I: Integrated Behavioral Health with SUD Resources Experimental Treatment 1 Intervention

Participating clinics receive a system-level intervention, an Integrated Behavioral Health System with SUD Resources, designed to improve youth connection to substance use treatment.

Group II: Primary Care Practice As Usual Active Control 1 Intervention

Data are collected regarding standard primary care practice and outcomes before implementation of SUD resources within the Integrated Behavioral Health System.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

The study identified five distinct models of integrated care for families affected by opioid use disorder (OUD), emphasizing the need for supportive and frequent visits with various providers, although billing constraints hinder full integration of services.

Key components for effective dyadic care include prioritizing care coordination, overcoming barriers to integrate medical and behavioral services, and ensuring child safety while maintaining parental trust, highlighting the complexities of addressing both parental and infant health needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caring for Families Impacted by Opioid Use: A Qualitative Analysis of Integrated Program Designs. Schiff, DM., Partridge, S., Gummadi, NH., et al.[2023]

Multidisciplinary care models that integrate treatment for opioid use disorder (OUD), hepatitis C (HCV), and HIV are essential for preventing the spread of these conditions, with 17 different models identified across various care settings.

Key components of effective care models include medication-assisted treatment for OUD, treatment for HIV and HCV, HIV pre-exposure prophylaxis, and behavioral health services, highlighting the importance of comprehensive approaches in managing these interconnected health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated Models of Care for Individuals with Opioid Use Disorder: How Do We Prevent HIV and HCV? Rich, KM., Bia, J., Altice, FL., et al.[2019]

A new standardized strategy for reporting adverse events (AEs) and serious adverse events (SAEs) in substance use disorder (SUD) clinical trials was developed, which aims to reduce the reporting burden while maintaining safety monitoring.

In a review of 17 SUD trials involving 6737 participants, the new strategy showed a significant reduction in irrelevant safety event reporting, leading to a more consistent safety assessment system tailored to the risks associated with specific trial interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for safety reporting in substance abuse trials. Lindblad, R., Campanella, M., Styers, D., et al.[2013]

Individuals with HIV who also use drugs face higher health risks compared to those without drug use, highlighting the need for integrated care models.

A systematic review of 22 studies revealed that while integrated HIV and opioid use disorder services exist, they often lack coordinated state-level policies and systems, suggesting that improved coordination and standardized tools could enhance service delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coordinating Systems of Care for HIV and Opioid Use Disorder: A Systematic Review of Enablers and Barriers to Integrated Service Access, and Systems and Tools Required for Implementation. Duffy, M., Ghosh, A., Geltman, A., et al.[2022]

In a study of 46,952 hospital patients, 158 received naloxone due to opioid-related issues, highlighting the ongoing risk of opioid oversedation in hospitalized patients.

The study suggests that implementing better sedation assessments and coordinated pain management strategies could help prevent the need for naloxone by reducing the reliance on opioids and minimizing the use of multiple sedating medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of required sedation assessment in nursing workflow to address naloxone utilization. Hardison, E., Bloomer, A., Wally, MK., et al.[2023]

Citations

1. withpower.com withpower.com/trial/phase-substance-related-disorders-8-2024-bee8e

Integrated Behavioral Health for Adolescent Opioid Use ... This project seeks to address the increasing risk of overdose death, substance use disorder (SUD), and opioid use disorder (OUD) in adolescents.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12215800/

A cluster-randomized stepped-wedge trial IBH has the potential to reduce overdose rates by enhancing primary care provider willingness to deliver SUD services for adolescents. Keywords: ...

3. tandfonline.com tandfonline.com/doi/full/10.1080/15374416.2025.2521855

Evidence Base on Outpatient Behavioral Treatments for ... This systematic review (1) updates the evidence base on outpatient behavioral treatments for adolescent substance use (ASU) since publication of ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8380663/

Integrating substance use care into primary ... - PubMed Central We report the following patient characteristics and outcomes: demographics; proportion with substance use and mental health diagnoses; receipt of medications ...

5. samhsa.gov samhsa.gov/libraries/evidence-based-practices-resource-center

Evidence-Based Practices Resource Center This guide reviews interventions on treating substance misuse and substance use disorders (SUD) in youth with serious emotional disturbances (SED), distills ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0740547221001021

Integrating substance use care into primary ... We report the following patient characteristics and outcomes: demographics; proportion with substance use and mental health diagnoses; receipt ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7241222/

Adolescent Substance Use Disorder Treatment: An Update ... Over 90% of adults with a SUD began using alcohol or drugs during adolescence [2], and earlier initiation of substance use corresponds to a greater lifetime ...