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

NCT07693270 | Recruiting

• 1 other identifier: 814524
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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 Consumption; Persistent Postsurgical Pain; Opioid Use Disorder; Persistent Opioid Use

Keywords

opioid use disorder; artificial intelligence; persistent postsurgical pain

Outcome Measures

Primary Outcomes (1)

• Persistent Opioid Use

  We will collect blood from participants (about 15mL total) for DNA, miRNA, and mRNA sequencing. The blood draw for miRNA and mRNA sequencing, DNA genotyping, and bioinformatics analysis will be conducted at baseline and at subsequent in-person time points. All biospecimens will be sequenced and analyzed at UCSD's Center for Computational Biology and Bioinformatics. We will also collect baseline demographic, clinical and social data (including social determinants of health questionnaire, electronic health record data, demographic such as age, sex). These markers will be assessed for association of persistent opioid use defined as ongoing opioid use for more than 3 months after trauma/surgical admission.

  3 months after trauma injury/surgery

Secondary Outcomes (3)

• Pain via Brief Pain Inventory

  Baseline, 1 week, 1 month, 3 months, and 6 months after surgery

• Opioid Use Questionnaire

  Baseline, 1 week, 1 month, 3 months, and 6 months after surgery

• PROMIS-29 Questionnaire

  Baseline, 1 week, 1 month, 3 months, and 6 months after surgery

Study Arms (2)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will recruit up to 100 participants prospectively from UC Health sites, including Jacobs Medical Center, Hillcrest Hospital, McGrath Outpatient Pavilion, and Koman Outpatient Pavilion. Eligible participants will be identified by reviewing newly admitted patients in the trauma service and/or surgical suite (same day as surgery preoperatively).

You may qualify if:

• 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.

You may not qualify if:

• 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)).

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

La Jolla, California, 92037, United States

RECRUITING

Related Publications (6)

• Jones J, Correll DJ, Lechner SM, Jazic I, Miao X, Shaw D, Simard C, Osteen JD, Hare B, Beaton A, Bertoch T, Buvanendran A, Habib AS, Pizzi LJ, Pollak RA, Weiner SG, Bozic C, Negulescu P, White PF; VX21-548-101 and VX21-548-102 Trial Groups. Selective Inhibition of NaV1.8 with VX-548 for Acute Pain. N Engl J Med. 2023 Aug 3;389(5):393-405. doi: 10.1056/NEJMoa2209870.

  PMID: 37530822 BACKGROUND

• Zhang Z, Wang JJ, Ping ZG, Jin XG, Yang JJ, Wang Y, Chu QJ; Pain Group of the Chinese Society of Anesthesiology. The Impact of Opioid-Sparing Analgesia on Postoperative Pain and Recovery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Pain Ther. 2025 Oct;14(5):1473-1497. doi: 10.1007/s40122-025-00762-2. Epub 2025 Jul 25.

  PMID: 40711665 BACKGROUND

• Gabriel RA, Swisher MW, Sztain JF, Furnish TJ, Ilfeld BM, Said ET. State of the art opioid-sparing strategies for post-operative pain in adult surgical patients. Expert Opin Pharmacother. 2019 Jun;20(8):949-961. doi: 10.1080/14656566.2019.1583743. Epub 2019 Feb 27.

  PMID: 30810425 BACKGROUND

• Barocas JA, Savinkina A, Adams J, Jawa R, Weinstein ZM, Samet JH, Linas BP. Clinical impact, costs, and cost-effectiveness of hospital-based strategies for addressing the US opioid epidemic: a modelling study. Lancet Public Health. 2022 Jan;7(1):e56-e64. doi: 10.1016/S2468-2667(21)00248-6. Epub 2021 Nov 30.

  PMID: 34861189 BACKGROUND

• Jivraj NK, Raghavji F, Bethell J, Wijeysundera DN, Ladha KS, Bateman BT, Neuman MD, Wunsch H. Persistent Postoperative Opioid Use: A Systematic Literature Search of Definitions and Population-based Cohort Study. Anesthesiology. 2020 Jun;132(6):1528-1539. doi: 10.1097/ALN.0000000000003265.

  PMID: 32243330 BACKGROUND

• Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21.

  PMID: 28403427 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

The following samples will be collected on the day of hospital discharge: 5mL EDTA for miRNA, 4mL green top tube for mRNA, and 5mL DNA PAXgene for DNA sequencing. For all other time points requiring blood (7 days, 30 days, 90 days), we will collect 10mL (5mL EDTA for miRNA, 4mL green top tube for mRNA).

MeSH Terms

Conditions

Opioid-Related Disorders; Pain, Postoperative

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Rodney A Gabriel

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodney A Gabriel

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 9, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 17, 2026

Record last verified: 2026-06

Locations

US (1)