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A Universal Primary Care Based Intervention to Reduce Youth Overdose Risk Aim 3

NCT07797933 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 648

Last updated 2026-09-01

No results posted yet for this study

Summary

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, we propose a randomized controlled trial (RCT) to evaluate the efficacy of a brief universal overdose prevention intervention in pediatric primary care. We will enroll 24 providers and 624 youth patient participants randomized (at the provider level) to receive either the brief overdose prevention intervention or usual care.

Conditions

Interventions

BEHAVIORAL

Brief youth overdose prevention education

Providers in the intervention group will inform youth participants about: the risk factors for overdose, how to stay safe and prevent overdose, how to recognize an overdose, and how to respond to an overdose. Providers in the intervention group will also inform youth participants how to use naloxone and facilitate access if youth would like to have it.

OTHER

Usual Standard of Care

Youth participants will be provided usual care by providers in the control group. As part of usual care, providers may facilitate access to naloxone for youth control participants if they would like to have it.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Boston Medical Center

    lead OTHER

Principal Investigators

  • Sarah Bagley, MD · Boston Medical Center, Internal Medicine, Addiction Medicine

  • Amy Yule, MD · Boston Medical Center, Psychiatry

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2029-12-31
Completion
2029-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07797933 on ClinicalTrials.gov