NCT06350409 · Sharon Levy
Adolescent Outcomes of Post-operative Opioid EXposure
(APEX)
What this study 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
- Adolescents willing and able to provide informed assent and have a parent/caregiver willing to provide informed consent. Parent/Caregiver Inclusion Criteria
- Parent or legal guardian of an eligible adolescent.
- 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:
- Adolescents who have been prescribed opioids in the past 2 years for pain due to a chronic medical condition.
- Adolescents who have a current chronic medical condition that requires ongoing opioid pain management and treatment such as sickle cell disease, arthritis, or cancer.
- Adolescents who do not have a caregiver who is willing to co-participate in the study.
- Adolescents who cannot speak or read English at a 4th-grade level as determined by medical or research staff.
- 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.
- Adolescents who are currently in the custody of the Department of Children and Families or living with a foster family.
- Adolescents who are currently pregnant or parenting.
- 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.
- 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:
- Parents/Caregivers who cannot speak or read English or Spanish at a 4th grade level as determined by medical or research staff.
- Parents/Caregivers that are currently incarcerated.
- Parents/Caregivers that are in physical or mental distress that precludes study participation as determined by clinical or study staff.
Where
- Aurora, Colorado
- St. Petersburg, Florida
- Boston, Massachusetts
- Cincinnati, Ohio
- Philadelphia, Pennsylvania
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 18, 2026 · Source of record for eligibility and locations