Recruiting

Observational Study

Sponsor:

Sharon Levy

Code:

NCT06350409

Conditions

Opioid Use Disorder

Pain, Chronic

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Study Details

Brief 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. 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

Opioid Use Disorder

Pain, Chronic

Study ID

NCT06350409

Start date

Nov 12, 2024

Status verified date

Mar, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Risk of opioid use disorder due to prolonged pain that develops within the first year after surgery. [ Time Frame: 12 months ]
  • Risk of opioid use disorder due to prolonged opioid use that develops within the first year after surgery. [ Time Frame: 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. [ Time Frame: 12 monhts ]
  • 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 ]
  • Risk of opioid use disorder due to post-surgical trauma that develops within the first year after surgery. [ Time Frame: 12 months ]

Central Contacts and Locations

Locations

Boston Childrens Hopsital - Division of Addiction Medicine

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

More Information

Sponsor

Sharon Levy

Last update posted

Mar 18, 2026

Last verified

Mar, 2026

Keywords

  • Adolescent Opioid Use
  • Post operative pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sharon Levy on 2026-03-18.