Clinical trial NCT07022717: A Universal Primary Care Based Pilot Intervention to Reduce Youth Overdose Risk
Official title: A Universal Primary Care Based Pilot Intervention to Reduce Youth Overdose Risk
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Overdose
Keywords: Brief overdose prevention
Naloxone
Youth patients
Health care providers
Primary care
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2025-06-15
Enrollment: 24
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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)

Primary outcomes:
measure: Feasibility of the brief overdose prevention education intervention
timeFrame: 6 months
measure: Provider acceptability of the brief overdose prevention education intervention
timeFrame: 6 months
measure: Youth acceptability of the brief overdose prevention education intervention
timeFrame: 6 months
Secondary outcomes:
measure: Youth perception of risk associated with fentanyl and other emerging drugs
timeFrame: Baseline, 2 weeks, 6-months
measure: Youth awareness of strategies to reduce overdose risk
timeFrame: Baseline, 2 weeks, 6-months
measure: Youth's ability to recognize an overdose
timeFrame: Baseline, 2 weeks, 6-months
measure: Youth's ability to respond to an overdose
timeFrame: Baseline, 2 weeks, 6-months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center, Pediatric Primary Care & Family Medicine
state: Massachusetts
Study officials:
affiliation: Boston Medical Center, Internal Medicine, Addiction Medicine
name: Sarah Bagley, MD MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Medical Center, Psychiatry
name: Amy Yule, MD
role: PRINCIPAL_INVESTIGATOR
References: