Workforce and System Change to Treat Adolescent Opioid Use Disorder Within Integrated Pediatric Primary Care
Public ClinicalTrials.gov record NCT06477848. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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/).
Study identification
- NCT ID
- NCT06477848
- Recruitment status
- Enrolling by invitation
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 400 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 20, 2025
- Primary completion
- Aug 30, 2028
- Completion
- Aug 30, 2028
- Last update posted
- Aug 2, 2026
2025 – 2028
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06477848, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 2, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06477848 live on ClinicalTrials.gov.