Actively Recruiting

Phase Not Applicable
Age: 13Years +
All Genders
NCT07022717

A Universal Primary Care Based Intervention to Reduce Youth Overdose Risk

Led by Boston Medical Center · Updated on 2025-09-03

24

Participants Needed

1

Research Sites

40 weeks

Total Duration

On this page

Sponsors

B

Boston Medical Center

Lead Sponsor

N

National Institute on Drug Abuse (NIDA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Adolescent (ages 10-19) overdose deaths are the third leading cause of pediatric death and continue to rise in the United States. Healthcare providers have regular and trusted relationships with youth and have experience in providing public health injury prevention counseling. Youth have different motivations for using drugs, and many who experience fatal overdose do not have a history of opioid use. Primary care pediatric providers regularly provide developmentally appropriate injury prevention counseling for leading causes of pediatric fatal and nonfatal injury such as drowning prevention and firearms safety. However, there are no recommended, evidence-based overdose prevention interventions for youth, including in health care settings, even though research supports pediatricians and youth-serving clinicians providing harm reduction strategies such as naloxone distribution and overdose education. Among adults, overdose prevention education reduces overdose, is cost-effective, and can be learned by laypersons. Content commonly includes awareness of fentanyl in the drug supply, risk reduction (e.g., not using alone, risks of polysubstance use), and how to recognize and respond to an overdose, including the use of naloxone. This study is a pilot two-arm cluster randomized controlled trial (RCT) of a brief overdose prevention education intervention that will be developed in collaboration with the Community Advisory Board (CAB). The primary outcome of this study is to assess the feasibility and acceptability of the brief youth overdose prevention intervention as measured by provider feasibility and acceptability as well as youth acceptability.

CONDITIONS

Official Title

A Universal Primary Care Based Intervention to Reduce Youth Overdose Risk

Who Can Participate

Age: 13Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Physicians and advanced practice providers within Pediatric Primary Care and Family Medicine at Boston Medical Center
  • Providers working at least 2 clinic sessions per week
  • Youth aged 13 to 26 years
  • Youth scheduled for a comprehensive physical exam with a participating provider
  • Youth who speak English
Not Eligible

You will not qualify if you...

  • Caregivers of youth ages 13 to 17 unable to provide informed consent or who are not English speaking
  • Youth with cognitive limitations or intellectual disabilities as determined by their provider
  • Youth with any medical or psychiatric condition causing acute distress requiring emergency evaluation
  • Youth under legal custody of the Department of Children and Families (DCF)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Boston Medical Center, Pediatric Primary Care & Family Medicine

Boston, Massachusetts, United States, 02118

Actively Recruiting

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Research Team

S

Sarah Bagley, MD MSc

CONTACT

A

Ally Cogan, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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A Universal Primary Care Based Intervention to Reduce Youth Overdose Risk | DecenTrialz