Actively Recruiting

Age: 12Years - 17Years
All Genders
NCT06350409

Adolescent Outcomes of Post-operative Opioid EXposure

Led by Sharon Levy · Updated on 2026-03-18

20000

Participants Needed

5

Research Sites

168 weeks

Total Duration

On this page

Sponsors

S

Sharon Levy

Lead Sponsor

N

National Institute on Drug Abuse (NIDA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this observational study is to examine the factors associated with the transition from medical exposure to opioids with "signposts" of future opioid use disorder among adolescent surgical patients. The main question aims to identify factors (moderators, mediators, and covariates) associated with risk factors for opioid use disorder (ROUD) in the 12 months following major surgery with opioid exposure among adolescents aged 12-17. Participants will be asked to complete electronic surveys pre- and post-operatively and approve the collection of peri-operative data from the Electronic Medical Record to assess correlations.

CONDITIONS

Official Title

Adolescent Outcomes of Post-operative Opioid EXposure

Who Can Participate

Age: 12Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adolescents aged 12 to 17 years scheduled for surgery with a high likelihood of requiring opioid pain medicine for at least 48 hours after surgery
  • Adolescents able and willing to provide assent and have a parent or caregiver willing to provide consent
  • Parent or legal guardian of an eligible adolescent
  • Parent or legal guardian willing and able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Adolescents prescribed opioids in the last 2 years for chronic medical pain
  • Adolescents with chronic medical conditions needing ongoing opioid treatment like sickle cell disease, arthritis, or cancer
  • Adolescents without a willing caregiver to participate
  • Adolescents unable to speak or read English at a 4th-grade level
  • Adolescents currently in custody of youth services, jail/prison, or with pending legal actions preventing participation
  • Adolescents in custody of child welfare services or living with foster families
  • Adolescents who are pregnant or parenting
  • Adolescents or parents reporting a diagnosis of opioid use disorder or treatment with medications for it
  • Adolescents enrolled in other opioid or pain management intervention studies
  • Parents or caregivers who cannot speak or read English or Spanish at a 4th-grade level
  • Parents or caregivers currently incarcerated
  • Parents or caregivers in physical or mental distress preventing study participation

AI-Screening

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Trial Site Locations

Total: 5 locations

1

Children's Hospital Colorado

Aurora, Colorado, United States, 80045

Not Yet Recruiting

2

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, United States, 33701

Not Yet Recruiting

3

Boston Childrens Hopsital - Division of Addiction Medicine

Boston, Massachusetts, United States, 02115

Actively Recruiting

4

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Not Yet Recruiting

5

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Not Yet Recruiting

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Research Team

S

Sharon Levy, MD, MPH

CONTACT

J

Joesph Cravero, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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