Recruiting

Overdose Prevention

Sponsor:

Boston Medical Center

Code:

NCT07797933

Conditions

Overdose

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Not accepted

Interventions

Brief youth overdose prevention education

Usual Standard of Care

Study Details

Brief 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, 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.

Conditions

Overdose

Study ID

NCT07797933

Start date

Nov, 2026

Status verified date

Nov, 2026

Completion date

Aug, 2029

Anticipated

Primary completion date

Aug, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

648 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intervention group

Providers randomized to the intervention group will complete two 30-minute trainings in person or via videoconference. In the first training, providers will receive overdose prevention education and learn about the brief overdose prevention intervention. In the second training, providers will practice conducting the intervention and filling out the fidelity checklist that will be completed at the end of each appointment.

active comparator: Control group

Providers randomized to the control group will provide usual care to youth during comprehensive physical exam (CPE) or follow-up clinical appointments.

Interventions

Brief youth overdose prevention education

Providers in the intervention group will inform youth participants about: the risk factors for overdose, how to recognize an overdose, and how to respond to an overdose. Providers in the intervention group will also educate youth participants on naloxone use and provide assistance with accessing naloxone.

Usual Standard of Care

Youth participants will be provided usual care by providers in the control group. As part of usual care, providers may educate youth participants on naloxone use and provide assistance with accessing naloxone.

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Sarah Bagley, MD, MSc

(617) 414-7399sarah.bagley@bmc.org

Sarah Kosakowski, MPH

(617) 414-6906sarah.kosakowski@bmc.org

Locations

Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Sarah Bagley, MD

617-414-7399sarah.bagley@bmc.org

More Information

Sponsor

Boston Medical Center

Last update posted

Nov 10, 2026

Last verified

Nov, 2026

Keywords

  • Brief overdose prevention
  • Naloxone
  • Youth patients
  • Health care providers
  • Primary care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-11. This information was provided to ClinicalTrials.gov by Boston Medical Center on 2026-11-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.