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

400 Participants Needed

Trial Summary

What is the purpose of this trial?

This project seeks to address the increasing risk of overdose death, substance use disorder (SUD), and opioid use disorder (OUD) in adolescents. The investigators believe that pediatric primary care providers (PCP) could play an important role in helping youth with SUD because most adolescents see their PCPs for annual wellness visits. However, PCPs have many barriers to treating their young patients with SUD/OUD: lack of training, resources, and support to deliver SUD/OUD services, limited time with patients, and the only available referral options often come with long wait times for an appointment. Through this project, the investigators will build upon an existing Integrated Behavioral Health (IBH) system by offering stigma-reduction interventions and brief SUD interventions within primary care settings. The goal of this project is to learn if clinics participating in an Integrated Behavioral Healthcare Program with SUD resources will increase delivery of effective adolescent SUD care and ultimately lead to better health outcomes when compared to standard primary care treatment. During the first project phase, the research team will gather a Parent and Youth Advisory Board, Primary Care Provider Advisory Board, and Integrated Care Expert Panel (Aim 1) to inform the development and refinement of the primary care-based SUD interventions. The investigators will gather input from national experts, local stakeholders, and PCPs to refine our screening to treatment approach (Aim 2), coupled with stigma reduction activities, within pediatric primary care. During the second project phase, researchers will assess the impact of SUD IBH on PCP behaviors around adolescent SUD intervention. The investigators will interview and survey PCPs, clinic managers, and other clinical staff for willingness to engage in adolescent SUD treatment. The investigators will evaluate implementation outcomes (views toward SUD, stigma attitudes, IBH team dynamics; Aim 3) and effectiveness/reach outcomes (delivery of integrated primary care-based SUD services, the use of brief interventions for adolescents, number of consultation calls, and increased treatment engagement; Aim 4a), along with an exploratory test of local overdose rates for youth (Aim 4b), in order to examine local effects of the new intervention. This project is supported by the HEAL Initiative (https://heal.nih.gov/).

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 Integrated Behavioral Health System with SUD Resources treatment for adolescent opioid use disorder?

Research shows that adolescents with both substance use and mental health issues benefit from integrated care, which combines mental health and substance abuse services. This approach is recommended to reduce the risk of relapse and improve overall outcomes for youth facing these challenges. ^{1 2 3 4 5}

Is the Integrated Behavioral Health treatment for adolescent opioid use disorder safe?

There is no specific safety data available for the Integrated Behavioral Health treatment for adolescent opioid use disorder, but the need for integrated care for youth with substance abuse and trauma is emphasized, suggesting a focus on coordinated and safe treatment approaches. ^{1 6 7 8 9}

How is the Integrated Behavioral Health System with SUD Resources treatment different from other treatments for adolescent opioid use disorder?

This treatment is unique because it combines medical care with social services, focusing on a holistic approach that addresses both the medical and social needs of adolescents with opioid use disorder. It emphasizes integrated care, which means coordinating different types of support, like mental health and social work, to provide comprehensive support beyond just medication. ^{4 10 11 12 13}

Research Team

Leslie A Hulvershorn, MD

Principal Investigator

Indiana University/Indiana University Health

Zachary W Adams, PhD

Principal Investigator

Indiana University/Indiana University Health

Matthew C Aalsma, PhD

Principal Investigator

Indiana University/Indiana University Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Supporting the need for an integrated system of care for youth with co-occurring traumatic stress and substance abuse problems. [2012]

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

Cooccurring Psychiatric and Substance Use Disorders. [2017]

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

Outcomes of a comprehensive treatment program for adolescents with a substance-use disorder. [2019]

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

Caring for Families Impacted by Opioid Use: A Qualitative Analysis of Integrated Program Designs. [2023]

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

Predictors of abstinence: National Institute of Drug Abuse multisite buprenorphine/naloxone treatment trial in opioid-dependent youth. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Strategies for safety reporting in substance abuse trials. [2013]

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

Long-term prescription opioid utilization, substance use disorders, and opioid overdoses after adolescent trauma. [2023]

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

Substance Use Disorder Visits Among Adolescents at Children's Hospitals During COVID-19. [2023]

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

Implementation of required sedation assessment in nursing workflow to address naloxone utilization. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Perspectives on Medication Treatment for Opioid Use Disorder in Adolescents: Results from a Provider Learning Series. [2023]

11. United States 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. [2022]

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

Integrated Models of Care for Individuals with Opioid Use Disorder: How Do We Prevent HIV and HCV? [2019]

13. England pubmed.ncbi.nlm.nih.gov

Improving Treatment Together: a protocol for a multi-phase, community-based participatory, and co-design project to improve youth opioid treatment service experiences in British Columbia. [2021]