Identifying Biomarkers Related to Opioid Use and Pain Response Following Traumatic Injury and Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of California, San Diego
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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)).
Trial 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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 2 trial groupsGroup A: Persistent Opioid Use Cohort
Group B: Non-persistent Opioid Use Cohort
Trial outcomes
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.
Time frame
3 months after trauma injury/surgerySecondary outcomes
1
Pain via Brief Pain Inventory
The Brief Pain Inventory (BPI) is well-validated in clinical populations and will measure participants' self-reported pain on a 0 ("no pain") to 10 ("most severe pain") scale. We will use this survey to assess for average, minimal, and maximum pain and interference scores at multiple time points
Time frame
Baseline, 1 week, 1 month, 3 months, and 6 months after surgery2
Opioid Use Questionnaire
Opioid use will be collected directly from the electronic health record data and ascertained by patient report at the follow-up time points. At the 1-, 3-, and 6- month time point, we will elicit the average number of pain pills (name, dosing, frequency) over the last 7 days. This will be converted to oral MME.
Time frame
Baseline, 1 week, 1 month, 3 months, and 6 months after surgery3
PROMIS-29 Questionnaire
The PROMIS-29 questionnaire assesses a patient's physical and social well-being and measures pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance).
Time frame
Baseline, 1 week, 1 month, 3 months, and 6 months after surgerySponsors and contacts
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Source ClinicalTrials.gov