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NCT Number: NCT07797933

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

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.

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Key information

Conditions

Overdose Chemically-Induced Disorders Drug Misuse Drug Overdose Mental Disorders Prescription Drug Misuse Substance-Related Disorders

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Providers:

  • Physicians and advance 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 CPE or follow-up clinical appointment with a provider who is participating in the trial
  • English 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)

Treatment and study plan

Brief youth overdose prevention education

Behavioral

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.

usual standard of care

Other

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.

Primary outcomes

  1. Provider Fidelity to the Intervention

    Time frame: 12 months

    Providers in the intervention arm will complete a checklist after all CPEs and follow-up clinical appointments with youth ages 13 to 26 years. The checklist will assess provider consistency in delivery of the intervention including adherence to intervention topics and the provision of naloxone.

  2. Youth Fidelity to the Intervention

    Time frame: 12 months

    Youth in the intervention arm will complete a checklist after their CPEs and follow-up clinical appointments. The checklist will assess consistency in intervention delivery including adherence to intervention topics and whether naloxone was offered to the youth.

  3. Youth knowledge of risk associated with exposure to fentanyl and other emerging drugs

    Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.

    Assessed using a 4-point Likert-scale question measuring perceived risk of harm from taking prescription medication that was not prescribed or taking medication other than prescribed.

Secondary outcomes

  1. Youth knowledge of strategies to reduce overdose risk

    Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.

    Assessed using 4-point Likert-scale questions measuring perceived risk associated with using more than one substance at a time and using substances while alone.

  2. Youth's ability to recognize and respond to an overdose

    Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.

    Assessed using investigator-developed knowledge assessment questions evaluating recognition of overdose signs, appropriate overdose response, and knowledge of naloxone.

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Bagley, MD, MSc

CONTACT

[email protected]

(617) 414-7399

Sarah N Kosakowski, MPH

CONTACT

[email protected]

(617) 414-6906

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Sep 1, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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