Actively Recruiting

Phase Not Applicable
Age: 13Years +
All Genders
ID07022717

A Universal Primary Care Based Pilot Intervention to Reduce Youth Overdose Risk

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

24

Participants Needed

1

Research Sites

N/A

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 overdose deaths are a leading cause of death among youth aged 10 to 19 in the United States, with numbers continuing to rise. Researchers are evaluating a brief overdose prevention education intervention designed for youth in primary care settings. This pilot study aims to assess how feasible and acceptable this intervention is for both healthcare providers and young patients, addressing a gap as there are currently no recommended overdose prevention programs specifically for youth in healthcare. In this two-arm cluster randomized controlled trial, pediatric and family medicine providers are randomly assigned to either deliver the brief overdose prevention education or provide usual care. Providers in the intervention group receive a 45-minute training, conducted in person or via Zoom, which covers overdose prevention education, intervention delivery, practice, and fidelity checklist completion. The intervention includes informing youth about overdose risk factors, safety strategies, recognizing and responding to overdoses, and naloxone use, with naloxone kits offered to take home. Youth participants aged 13 to 26 scheduled for a comprehensive physical exam with participating providers complete assessments at baseline, 2 weeks, and 6 months. Researchers will measure the feasibility and acceptability of the intervention by providers and youth, as well as youth knowledge and skills related to overdose risk, recognition, and response. The study excludes youth unable to consent or with cognitive limitations or acute medical/psychiatric distress. Participation is tracked over six months to evaluate the intervention's impact and acceptability.

CONDITIONS

Brief 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 advance practice providers within Pediatric Primary Care and Family Medicine at Boston Medical Center
  • Providers must have at least 2 clinic sessions per week
  • Youth participants aged 13 to 26 years
  • Youth scheduled for a comprehensive physical exam with a participating provider
  • Youth must be English speaking
Not Eligible

You will not qualify if you...

  • Youth caregivers unable to provide informed consent or not English speaking (for youth ages 13-17)
  • 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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - Single session at a comprehensive physical exam

Participants receive either the brief youth overdose prevention education intervention or usual care during their comprehensive physical exam visits with their provider.

1 visit (in-person)

Monitoring

Duration - 6 months

Participants’ perceptions, awareness, and abilities related to overdose risk and response are assessed over time.

Visits at baseline, 2 weeks, and 6 months

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

A

Ally Cogan, MPH

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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