Teen surgery opioid study seeks to predict addiction risk
NCT ID NCT06350409
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study follows 20,000 adolescents aged 12-17 who receive opioids after major surgery. Researchers track pain, opioid use, and other factors for one year to identify early warning signs of opioid use disorder. Participants complete surveys and allow access to their medical records, but no experimental treatment is given.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 20,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
This study aims to recruit a convenience sample of approximately 10,000 dyads of adolescent (12-17 years, inclusive) patients and one parent (Total N=20,000). Adolescent participants will be undergoing scheduled surgeries with a greater than 90% likelihood of requiring opioid analgesia for at least 48 hours post-operatively (as an inpatient) or discharged home with at least a 48-hour supply of prescription opioids. Opioid prescribing practices vary by institution; therefore, eligible surgical procedures will be determined on a site-by-site basis. Exemplar surgeries at BCH and CCHMC sites include spinal fusion surgery, Nuss procedure, and anterior cruciate ligament reconstruction. Both inpatient and outpatient surgical procedures will be considered. All adolescent participants will be aged 12-17 at the time of enrollment and are children as defined by the NIH Policy on I
- Ages
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12 to 17 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Adolescent Inclusion Criteria 1. Adolescents between the ages of 12 to 17 years old, inclusive, who are scheduled to undergo a scheduled surgical procedure with a greater than 90% likelihood of requiring opioid analgesia for at least 48 hours post-operatively (as an inpatient) or discharged home with at least a 48-hour supply of prescription opioids. • Opioid prescribing practices vary by institution; therefore, eligible surgical procedures will be determined on a site-by-site basis. 2. Adolescents willing and able to provide informed assent and have a parent/caregiver willing to provide informed consent. Parent/Caregiver Inclusion Criteria 1. Parent or legal guardian of an eligible adolescent. 2. Parent or legal guardian willing and able to provide written informed consent. Adolescent Exclusion Criteria Adolescents meeting any of the following criteria will be excluded from study participation: 1. Adolescents who have been prescribed opioids in the past 2 years for pain due to a chronic medical condition. 2. Adolescents who have a current chronic medical condition that requires ongoing opioid pain management and treatment such as sickle cell disease, arthritis, or cancer. 3. Adolescents who do not have a caregiver who is willing to co-participate in the study. 4. Adolescents who cannot speak or read English at a 4th-grade level as determined by medical or research staff. 5. Adolescents who are currently in the custody of the Department of Youth Services, jail/prison, or other overnight facility as required by court of law or have pending legal action that could prevent participation in study activities. 6. Adolescents who are currently in the custody of the Department of Children and Families or living with a foster family. 7. Adolescents who are currently pregnant or parenting. 8. Adolescents that self or parent report of ever having been diagnosed with opioid use disorder, or prescribed buprenorphine, methadone, or naltrexone to treat opioid use disorder. 9. Adolescents who are currently enrolled in an intervention study that aims to impact opioid prescription or pain management pre-, peri-, or post-operatively. Parent/Caregiver Exclusion Criteria Parents/Caregivers meeting any of the following criteria will be excluded from study participation: 1. Parents/Caregivers who cannot speak or read English or Spanish at a 4th grade level as determined by medical or research staff. 2. Parents/Caregivers that are currently incarcerated. 3. Parents/Caregivers that are in physical or mental distress that precludes study participation as determined by clinical or study staff.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Boston Childrens Hopsital - Division of Addiction Medicine
RECRUITINGBoston, Massachusetts, 02115, United States
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Children's Hospital Colorado
NOT_YET_RECRUITINGAurora, Colorado, 80045, United States
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Children's Hospital of Philadelphia
NOT_YET_RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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Cincinnati Children's Hospital Medical Center
NOT_YET_RECRUITINGCincinnati, Ohio, 45229, United States
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Johns Hopkins All Children's Hospital
NOT_YET_RECRUITINGSt. Petersburg, Florida, 33701, United States
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