Opioid Use DisorderAPEXNCT06350409
Adolescent Outcomes of Post-operative Opioid EXposure
An observational study of Opioid Use Disorder and Pain, Chronic, run by Sharon Levy at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Opioid Use Disorder, Pain, Chronic
- How many people
- 20,000 participants
- Where
- 5 sitesUnited States
- Study dates
- 12 Nov 2024to Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: 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
Adolescent 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Joesph Cravero, MD contact
5 sites in 1 country
United States5 sites, 5 recruiting
- Not yet recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
Tessa Mandler, MD, 800-624-6553, Tessa.Mandler@childrenscolorado.org
- Recruiting
Boston Childrens Hopsital - Division of Addiction Medicine
Boston, Massachusetts, 02115
Melissa Brogna, MSW, 857-218-4311, Melissa.Brogna@childrens.harvard.edu
- Not yet recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Vydia Chidambaran, MD, (513) 636-4408, Vidya.Chidambaran@cchmc.org
Charlotte Walter, MD
- Not yet recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Tori Sutherland, MD, 215-590-1000, SUTHERLANT@chop.edu
- Not yet recruiting
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
Allison Fernandez, MD, 800-456-4543, aferna27@jhmi.edu
About this study
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.
Read the detailed description
This project will collect data from a diverse sample of 10,000 dyads, including adolescent (aged 12-17 years, inclusive) patients undergoing major surgery with planned post-operative opioid analgesic use. and a parent (Total N=20,000) to identify ROUD that may occur within the 12 months after surgery. The resulting data repository will allow clinician scientists and physicians to develop research-informed pain management protocols for adolescent surgical patients to reduce the risk of OUD in this vulnerable population.
Using a novel combination of data sources (electronic medical records (EMR), patient-reported outcomes, and parent-reported outcomes), this study investigates the twin problems of postoperative pain and ROUD in adolescent surgical patients. Using real-world evidence to evaluate longitudinal behaviors and outcomes.
This project will provide insights into the associations between post-operative pain management and ROUD in adolescents. Findings could yield information about potential risks, which may inform future studies and ultimately lead to new screening tools to assess risk before opioid prescribing, updated protocols for managing pain intra-operatively and post-operatively in high-risk populations, updated patient and family education materials to reduce risks for those undergoing painful procedures, and revised recommendations for monitoring for patients being treated for pain. Furthermore, the project enables the establishment of an infrastructure among pediatric surgical centers that can be used for future projects to evaluate the best postoperative outcomes for youth.
Aim 1: Determine the frequency of ROUD. Because this is a novel measure of ROUD, we will use the first 1,000 samples to estimate the incidence of ROUD developing among adolescents in the year following surgery with post-operative opioid analgesia.
Aim 2: We will use machine learning models to develop and validate screening algorithms designed to detect "early warning signs" or Risk factors for Opioid Use Disorder (ROUD). The features in these models will include the pre-, intra- and postoperative EMR-derived data elements, as well as the survey data. We will fit the models against the primary outcome described above. Model evaluation will be done via cross-validation, where the models will be fit on a randomly selected training set of patients and evaluated on the remaining held-out subset of the patients to be used exclusively for testing the performance of the final models.
Aim 3: Developing and validating a prediction model designed to predict a clinical trajectory of post-surgical opioid use and pain. We will use clustering to identify typical patient trajectories of opioid use, and we will use similar prediction and validation techniques as in Aim 1 to build a prediction model for these trajectories.
- Conditions
- Opioid Use Disorder, Pain, Chronic
- Keywords
- Adolescent Opioid Use, Post operative pain
- Medical subject headings
- Opioid-Related Disorders, Chronic Pain, Pain, Postoperative
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of opioid use disorder due to prolonged pain that develops within the first year after surgery.
The patient self-report an average pain score of more than 3/10 in the last 7 days on the Brief Pain Inventory (BPI) at 3 or more months postoperatively.
Measured: 12 months
Risk of opioid use disorder due to prolonged opioid use that develops within the first year after surgery.
Any adolescent self-report or parent report of opioid medication use more than 3 or more months postoperatively.
Measured: 12 months
Risk of opioid use disorder due to postoperative non-medical use of prescription opioids (NMUPO) that develops within the first year after surgery.
Any adolescent self-report or parent report of use of opioid medication that is > than prescribed, or more frequently than prescribed, or not prescribed to the adolescent.
Measured: 12 monhts
Risk of opioid use disorder due to increased rate of change in substance use that develops within the first year after surgery.
Adolescent self-report of rate of increase of substance use frequency greater than the 75th percentile of an age- and sex-matched cohort compared to nationally representative data
Measured: 12 month
Risk of opioid use disorder due to post-surgical trauma that develops within the first year after surgery.
Adolescent self-report of post-surgical trauma and stress as measured by >11 on the Child PTSD Symptom Scale (CPSS) 3 or more months postoperatively.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start12 Nov 2024
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sharon Levy
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)
- Responsible party
- Sponsor-investigator, Sharon Levy, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06350409
- Sponsor's protocol ID
- CTN-0146
- Other IDs
- UG1DA015831-22S4, 3UG1DA015831-24S1
- Acronym
- APEX
- Status last verified
- Mar 2026
- First submitted
- 1 Apr 2024
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent Outcomes of Post-operative Opioid EXposure
- ClinicalTrials.gov ID
- NCT06350409
- Acronym / sponsor ID
- APEX / CTN-0146
- Conditions
- Opioid Use Disorder, Pain, Chronic
- Keywords
- Adolescent Opioid Use, Post operative pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Sharon LevyUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 5 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This project will collect data from a diverse sample of 10,000 dyads, including adolescent (aged 12-17 years, inclusive) patients undergoing major surgery with planned post-operative opioid analgesic use. and a parent (Total N=20,000) to identify ROUD that may occur within the 12 months after surgery. The resulting data repository will allow clinician scientists and physicians to develop research-informed pain management protocols for adolescent surgical patients to reduce the risk of OUD in this vulnerable population.
Using a novel combination of data sources (electronic medical records (EMR), patient-reported outcomes, and parent-reported outcomes), this study investigates the twin problems of postoperative pain and ROUD in adolescent surgical patients. Using real-world evidence to evaluate longitudinal behaviors and outcomes.
This project will provide insights into the associations between post-operative pain management and ROUD in adolescents. Findings could yield information about potential risks, which may inform future studies and ultimately lead to new screening tools to assess risk before opioid prescribing, updated protocols for managing pain intra-operatively and post-operatively in high-risk populations, updated patient and family education materials to reduce risks for those undergoing painful procedures, and revised recommendations for monitoring for patients being treated for pain. Furthermore, the project enables the establishment of an infrastructure among pediatric surgical centers that can be used for future projects to evaluate the best postoperative outcomes for youth.
Aim 1: Determine the frequency of ROUD. Because this is a novel measure of ROUD, we will use the first 1,000 samples to estimate the incidence of ROUD developing among adolescents in the year following surgery with post-operative opioid analgesia.
Aim 2: We will use machine learning models to develop and validate screening algorithms designed to detect "early warning signs" or Risk factors for Opioid Use Disorder (ROUD). The features in these models will include the pre-, intra- and postoperative EMR-derived data elements, as well as the survey data. We will fit the models against the primary outcome described above. Model evaluation will be done via cross-validation, where the models will be fit on a randomly selected training set of patients and evaluated on the remaining held-out subset of the patients to be used exclusively for testing the performance of the final models.
Aim 3: Developing and validating a prediction model designed to predict a clinical trajectory of post-surgical opioid use and pain. We will use clustering to identify typical patient trajectories of opioid use, and we will use similar prediction and validation techniques as in Aim 1 to build a prediction model for these trajectories.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Risk of opioid use disorder due to prolonged pain that develops within the first year after surgery.
Time frame: 12 months
The patient self-report an average pain score of more than 3/10 in the last 7 days on the Brief Pain Inventory (BPI) at 3 or more months postoperatively.
Risk of opioid use disorder due to prolonged opioid use that develops within the first year after surgery.
Time frame: 12 months
Any adolescent self-report or parent report of opioid medication use more than 3 or more months postoperatively.
Risk of opioid use disorder due to postoperative non-medical use of prescription opioids (NMUPO) that develops within the first year after surgery.
Time frame: 12 monhts
Any adolescent self-report or parent report of use of opioid medication that is > than prescribed, or more frequently than prescribed, or not prescribed to the adolescent.
Risk of opioid use disorder due to increased rate of change in substance use that develops within the first year after surgery.
Time frame: 12 month
Adolescent self-report of rate of increase of substance use frequency greater than the 75th percentile of an age- and sex-matched cohort compared to nationally representative data
Risk of opioid use disorder due to post-surgical trauma that develops within the first year after surgery.
Time frame: 12 months
Adolescent self-report of post-surgical trauma and stress as measured by >11 on the Child PTSD Symptom Scale (CPSS) 3 or more months postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- APEX study information websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joesph Cravero, MD contact
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Use Disorder and Pain, Chronic, run by Sharon Levy at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sharon Levy, MD, MPH (857-218-4308, sharon.levy@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of opioid use disorder due to prolonged pain that develops within the first year after surgery. (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.