NCT07693270 Identifying Biomarkers Related to Opioid Use and Pain Response Following Traumatic Injury and Surgery
| NCT ID | NCT07693270 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Diego |
| Condition | Opioid Use Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-07-15 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2026-07-15 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The mechanisms leading to opioid tolerance or dependence are not well understood and there are currently no biomarkers for predicting who is at risk for development of OUD. The purpose of this project is to support the feasibility of detecting a miRNA bio-behavioral signature of opioid misuse risk that will demonstrate improved predictive precision compared to current tools such as polygenic risk scores (PRS). Specifically, the study will address key goals of the Wellcome Leap program to develop scalable measures assessing individual addiction susceptibility and quantifying addiction risk and progression during prescription drug use. The study will utilize behavioral, genomics, and bioinformatics pipelines to characterize opioid-induced miRNA expression dynamics among trauma and surgical patients prescribed opioids at discharge. Based on results from this study, the research will develop a high-throughput screening assay to predict risk for opioid use disorder (OUD). The hypothesis is that miRNAs will serve as powerful bio-signatures for predicting long-term clinical outcomes in patients treated with opioids for pain management following trauma injury and/or surgery.
Eligibility Criteria
Inclusion Criteria: * Patients 18 years of age or older * Patients admitted for traumatic injury at Hillcrest or Jacobs Medical Center or patients who will undergo the orthopedic (e.g., joint, spine), abdominal, breast, vascular (e.g., amputation), or thoracic surgery. Exclusion Criteria: * Patients with a prior history of opioid use disorder or dependence * Pregnant women * Prisoners * Patients with an inability to independently provide informed consent to participate in the study due to lack of capacity. This lack of capacity can be from either a chronic/continuous condition (i.e. dementia), or can be temporary (i.e. clear signs of intoxication at the time of the visit (not alert or oriented, slurring words \[and confirmed not to be baseline\], unsteady gait \[and confirmed not to be baseline\], or appears impaired based on clinical judgement by PI/Co-I)).
Contact & Investigator
Rodney A Gabriel
PRINCIPAL INVESTIGATOR
University of California, San Diego
Frequently Asked Questions
Who can join the NCT07693270 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Opioid Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07693270 currently recruiting?
Yes, NCT07693270 is actively recruiting participants. Contact the research team at ragabriel@health.ucsd.edu for enrollment information.
Where is the NCT07693270 trial being conducted?
This trial is being conducted at La Jolla, United States.
Who is sponsoring the NCT07693270 clinical trial?
NCT07693270 is sponsored by University of California, San Diego. The principal investigator is Rodney A Gabriel at University of California, San Diego. The trial plans to enroll 100 participants.