NCT07022717 A Universal Primary Care Based Intervention to Reduce Youth Overdose Risk
| NCT ID | NCT07022717 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston Medical Center |
| Condition | Overdose |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-08-25 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2025-08-25 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria for providers: * Physicians and advance practice providers within Pediatric Primary Care and Family Medicine at Boston Medical Center (BMC) * ≥ 2 clinic sessions per/week Exclusion Criteria for providers: * None Inclusion criteria for youth: * Ages 13-26 * Scheduled for a comprehensive physical exam with a provider who is participating in the trial * English speaking Exclusion criteria for 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 * Any medical/psychiatric condition that causes acute distress and requires emergency evaluation * Under legal custody of the Department of Children and Families (DCF)
Contact & Investigator
Sarah Bagley, MD MSc
PRINCIPAL INVESTIGATOR
Boston Medical Center, Internal Medicine, Addiction Medicine
Frequently Asked Questions
Who can join the NCT07022717 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, studying Overdose. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07022717 currently recruiting?
Yes, NCT07022717 is actively recruiting participants. Contact the research team at sarah.bagley@bmc.org for enrollment information.
Where is the NCT07022717 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT07022717 clinical trial?
NCT07022717 is sponsored by Boston Medical Center. The principal investigator is Sarah Bagley, MD MSc at Boston Medical Center, Internal Medicine, Addiction Medicine. The trial plans to enroll 24 participants.