Not a traditional drug phase: Brief youth overdose prevention education for Overdose
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.
Official registry: https://clinicaltrials.gov/study/NCT07797933 · Boston Medical Center · enrollment listed as 648
What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Brief youth overdose prevention education, or Usual Standard of Care. The registry lists allocation as randomized. 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).
They plan to enroll about 648 people at Boston. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.
Official title (unrewritten)
A Universal Primary Care Based Intervention to Reduce Youth Overdose Risk Aim 3
Interventions: Brief youth overdose prevention education, Usual Standard of Care
Primary outcome (registry wording): Youth knowledge of risk associated with exposure to fentanyl and other emerging drugs
Who it is for (from inclusion criteria)
- Ages 13 Years to any
- 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
- 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
Who the registry excludes
- 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)
- 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)
Public study contact (from the registry)
Sarah Bagley, MD, MSc
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- Boston Medical Center — Boston, Massachusetts (recruiting)
FAQ about this NCT record
Is NCT07797933 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07797933?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07797933?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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