A Universal Primary Care Based Intervention to Reduce Youth Overdose Risk

NCT07022717 | Recruiting DMC

• 2 other identifiers: H-45731R61DA062217
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Overdose

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Feasibility of the brief overdose prevention education intervention

  Providers in the intervention arm will complete a checklist after all comprehensive physical exams with youth ages 13 to 26 years. The checklist will assess which components of the intervention the provider was able to deliver during the visit.

  6 months

• Provider acceptability of the brief overdose prevention education intervention

  Providers in the intervention group will complete 8 questions based on the Theoretical Framework of Acceptability (TFA) acceptability questionnaire on a 5-point Likert scale. The measure will be collected post-intervention training and after all youth have received the intervention

  6 months

• Youth acceptability of the brief overdose prevention education intervention

  Youth participants receiving care from providers in the interventions group will be asked after their comprehensive physical exam questions from an investigator developed questionnaire to rate their experience of the visit, receipt of the brief youth overdose prevention education intervention, importance, relevance, and comfort with the information.

  6 months

Secondary Outcomes (4)

• Youth perception of risk associated with fentanyl and other emerging drugs

  Baseline, 2 weeks, 6-months

• Youth awareness of strategies to reduce overdose risk

  Baseline, 2 weeks, 6-months

• Youth's ability to recognize an overdose

  Baseline, 2 weeks, 6-months

• Youth's ability to respond to an overdose

  Baseline, 2 weeks, 6-months

Study Arms (2)

Intervention group

EXPERIMENTAL

Providers randomized into this arm will complete a 45-minute intervention training. The training will occur either in person or via Zoom teleconference and include overdose prevention education, the pilot brief overdose prevention education intervention, intervention practice, and how to complete the fidelity checklist to be completed at the end of each visit.

Behavioral: Brief youth overdose prevention education; Other: Information about Naloxone

Control group

ACTIVE COMPARATOR

Providers randomized into this arm will deliver usual care to the youth patients.

Other: Usual standard of care

Interventions

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.

Intervention group

Information about Naloxone OTHER

Providers in the intervention group will inform youth participants how to use naloxone and offered a kit to take home.

Also known as: Narcan

Intervention group

Usual standard of care OTHER

Participants will be provided usual care by providers in the control group.

Control group

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Physicians and advance practice providers within Pediatric Primary Care and Family Medicine at Boston Medical Center (BMC)
• ≥ 2 clinic sessions per/week

You may not qualify if:

• None
• Ages 13-26
• Scheduled for a comprehensive physical exam with a provider who is participating in the trial
• English speaking
• 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
• Any medical/psychiatric condition that causes acute distress and requires emergency evaluation
• Under legal custody of the Department of Children and Families (DCF)

Sponsors & Collaborators

• Boston Medical Center: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Boston Medical Center, Pediatric Primary Care & Family Medicine

Boston, Massachusetts, 02118, United States

RECRUITING

MeSH Terms

Conditions

Drug Overdose

Interventions

Naloxone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Sarah Bagley, MD MSc

  Boston Medical Center, Internal Medicine, Addiction Medicine

  PRINCIPAL INVESTIGATOR

• Amy Yule, MD

  Boston Medical Center, Psychiatry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Bagley, MD MSc

CONTACT

617 414 6906; sarah.bagley@bmc.org

Ally Cogan, MPH

CONTACT

617 414 6906; ally.cogan@bmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: June 15, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)