Identifying Biomarkers Related to Opioid Use and Pain Response Following Traumatic Injury and Surgery

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT07693270
Status
Not Yet Recruiting

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Conditions

  • Opioid Consumption
  • Opioid Use Disorder
  • Persistent Opioid Use
  • Persistent Postsurgical Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Jul 9, 2026
Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Persistent Opioid Use Cohort
    Patients who develop persistent opioid use after surgery (defined as any ongoing opioid use \>3 months after admission for trauma injury)
  • Arm: Non-persistent Opioid Use Cohort
    Patients who do not develop persistent opioid use after surgery (defined as no ongoing opioid ≥ 3 months after surgery)

Primary Outcome Measure

Persistent Opioid Use [ Time Frame: 3 months after trauma injury/surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San DiegoLa JollaCalifornia92037
Rodney A Gabriel
[email protected]
858-663-7747
Rodney A Gabriel (PRINCIPAL_INVESTIGATOR)

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