Recruiting

miRNA Signature

Sponsor:

UCLA

Code:

NCT07693270

Conditions

Opioid Use Disorder

Opioid Consumption

Persistent Opioid Use

Persistent Postsurgical Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Opioid Use Disorder

Opioid Consumption

Persistent Opioid Use

Persistent Postsurgical Pain

Study ID

NCT07693270

Start date

Jul 15, 2026

Status verified date

Jun, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)).

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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)

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 and Locations

Central contacts

Rodney A Gabriel

858-663-7747ragabriel@health.ucsd.edu

Locations

University of California, San Diego

Recruiting

La Jolla, California, United States, 92037

Contacts

Rodney A Gabriel

858-663-7747ragabriel@health.ucsd.edu

Principal Investigator:

Rodney A Gabriel

More Information

Sponsor

University of California, San Diego

Last update posted

Jul 17, 2026

Last verified

Jun, 2026

Keywords

  • opioid use disorder
  • artificial intelligence
  • persistent postsurgical pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-07-17.