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NCT06350409 · ClinicalTrials.gov registry record
Adolescent Outcomes of Post-operative Opioid EXposure
A clinical trial of Opioid Use Disorder and Pain, Chronic, sponsored by Sharon Levy.
- Recruiting
- Registry status
- 20,000
- Enrollment target
- 5
- Study locations
NCT06350409: Recruiting study of Opioid Use Disorder and Pain, Chronic, sponsored by Sharon Levy.
NCT06350409 is a study of Opioid Use Disorder and Pain, Chronic that is actively recruiting participants, run by Sharon Levy. The registered enrollment target is 20,000 participants, above the 4,578-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (337% higher). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06350409, a study of Opioid Use Disorder and Pain, Chronic, is actively recruiting participants, sponsored by Sharon Levy.
- RECRUITING
- Registry status
- 20,000 participants
- Enrollment target
- 5
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Study Locations (5)
Colorado
- Children's Hospital Colorado - Aurora
Florida
- Johns Hopkins All Children's Hospital - St. Petersburg
Massachusetts
- Boston Childrens Hopsital - Division of Addiction Medicine - Boston
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20,000 participants |
| Start Date | 2024-11-12 |
| Est. Completion | 2028-02 |
What NCT06350409 shows while recruiting
NCT06350409 is an observational study that tracks outcomes without assigning an intervention. Its 20,000 participants enrollment target places it among the larger protocols in the corpus, above the 4,578-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (337% higher).
The record links to 2 conditions, with Opioid Use Disorder appearing as the primary indexed condition, and to 0 interventions.
NCT06350409 lists 5 locations in 5 states (Colorado, Florida, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT06350409 about?
NCT06350409 is a clinical study titled "Adolescent Outcomes of Post-operative Opioid EXposure". 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) associa...
What is the current status of trial NCT06350409?
This trial is currently recruiting. The enrollment target is 20,000 participants. The study started on 2024-11-12. Estimated completion is 2028-02.
What conditions does trial NCT06350409 study?
This clinical trial studies the following conditions: Opioid Use Disorder, Pain, Chronic.
Who is sponsoring clinical trial NCT06350409?
This trial is sponsored by Sharon Levy, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06350409 being conducted?
This trial has 5 study locations across Colorado, Florida, Massachusetts, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06350409's enrollment target sits among peer trials
20,000 5th of 257 higher than 253 of 257 other Opioid Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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