Home › Opioid Overdose › NCT07797933
A Universal Primary Care Based Intervention to Reduce Youth Overdose Risk Aim 3
Who can join
Ages 13 and older · All sexes
Full eligibility criteria
Inclusion Criteria: Providers: * Physicians and advanced practice providers (nurse practitioners and physician assistants) within Pediatric Primary Care and Family Medicine at Boston Medical Center, NeighborHealth, and South Boston Community Health Center * ≥ 1 clinic session per week Youth: * Ages 13 - 26 * Scheduled for a comprehensive physical exam (CPE) or follow-up clinical appointment with a provider who is participating in the trial * English or Spanish speaking Exclusion Criteria: Providers: * Participated as an intervention provider in the R61 pilot RCT (H-45731) * Participated in the Community Advisory Board that assisted in the development of the intervention (H-45388) Youth: * Caregivers of youth ages 13-17 unable to provide informed consent or are not English speaking * Cognitive limitation or intellectual disability that in the opinion of their provider would not be able to complete the requirements of the research * Young adults ages 18-26 with a legal guardian * Any medical/psychiatric condition that causes acute distress and requires emergency evaluation * Under legal custody of the Department of Children and Families (DCF) * Participated in the intervention arm of the R61 pilot RCT (H-45731)
About the study
Between 2015 and 2019, overdose deaths translated to 1.25 million years of life lost among adolescents and young adults (youth) aged 12 to 24 years, and the percent change in fatal overdose rates among adolescents ages 14 to 18 was higher than adults between 2019 and 2020.3-5 Primary care providers are uniquely positioned to provide evidence-based information to youth to both improve awareness of overdose risk (individual benefit) and simultaneously ensure that youth are prepared to recognize and respond to an overdose (public health benefit). However, currently there is no evidence-based intervention for pediatric primary care to reduce youth overdose risk and ensure youth can recognize and respond to an overdose.
To address the gap in evidence-based overdose prevention interventions for youth, the investigators propose a randomized controlled trial (RCT) to evaluate the efficacy of a brief universal overdose prevention intervention in pediatric primary care. Twenty-four providers and 624 youth patient participants randomized (at the provider level) will be enrolled to receive either the brief overdose prevention intervention or usual care will be enrolled.
What is being tested
- Brief youth overdose prevention education (behavioral)
- Usual Standard of Care (other)
Sponsor: Boston Medical Center · Participants: 648 · Started: 2026-11
Contact the study team
- Sarah Bagley, MD, MSc · Phone: (617) 414-7399
- Sarah Kosakowski, MPH · Phone: (617) 414-6906
Official record on ClinicalTrials.gov — NCT07797933
Locations in the U.S.
| Massachusetts | Boston Medical Center, Boston |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.