Klinische proef op Opioïdengebruiksstoornis, Opioïde consumptie, Aanhoudende postoperatieve pijn, Persistent Opioid Use - Register voor klinische proeven

Studie Overzicht

Toestand

Werving

Conditie

Gedetailleerde beschrijving

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.

The specific aim is to develop a new conceptual framework to validate DNA< mRNA, and miRNAs as biomarkers of persistent opioid use among patients after traumatic injury and/or surgery.

The primary goal is to correlate patterns in miRNA sequencing with persistent opioid use after trauma/surgery.

The study will recruit up to 100 adult (>18 yo) 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).

The study will collect baseline data including baseline clinical and demographic data, pain/opioid use from surveys/questions, social determinants of health (from survey), and biospecimens (blood for DNA and miRNA sequencing). Data will be collected initially near estimated hospital discharge (baseline), at 7 days post-discharge, 1 month post-discharge, 3 months post-discharge and 6 months post-discharge.

The proposed project will identify a miRNA signature associated with risk for persistent opioid use (defined as ongoing opioid use at 1, 3 and 6 months after index time point) in patients following exposure to opiate medication after traumatic injury/surgery. It is expected to demonstrate improved predictive precision with the miRNA signature compared to current tools alone (PRS, ORT). Success of this project will provide the go signal for a subsequent implementation study to develop a miRNA test kit and optimize the use of this screening tool and its potential to inform targeted interventions to prevent persistent opioid use and OUD after traumatic injury/surgery.

Studietype

Observationeel

Inschrijving (Geschat)

100

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Naam: Rodney A Gabriel
Telefoonnummer: 858-663-7747
E-mail: ragabriel@health.ucsd.edu

Studie Locaties

Verenigde Staten
- California
  - La Jolla, California, Verenigde Staten, 92037
    - Werving
    - University of California, San Diego
    - Contact:
      
      Rodney A Gabriel
      
      Telefoonnummer: 858-663-7747
      
      E-mail: ragabriel@health.ucsd.edu
    - Hoofdonderzoeker:
      
      Rodney A Gabriel

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Volwassen
Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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).

Beschrijving

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)).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Aantal groepen / cohorten

2

Cohorten en interventies

Groep / Cohort
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)

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Persistent Opioid Use Tijdsspanne: 3 months after trauma injury/surgery	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

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Pain via Brief Pain Inventory Tijdsspanne: Baseline, 1 week, 1 month, 3 months, and 6 months after surgery	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	Baseline, 1 week, 1 month, 3 months, and 6 months after surgery
Opioid Use Questionnaire Tijdsspanne: Baseline, 1 week, 1 month, 3 months, and 6 months after surgery	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.	Baseline, 1 week, 1 month, 3 months, and 6 months after surgery
PROMIS-29 Questionnaire Tijdsspanne: Baseline, 1 week, 1 month, 3 months, and 6 months after surgery	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).	Baseline, 1 week, 1 month, 3 months, and 6 months after surgery

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of California, San Diego

Onderzoekers

Hoofdonderzoeker: Rodney A Gabriel, University of California, San Diego

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

15 juli 2026

Primaire voltooiing (Geschat)

1 juni 2027

Studie voltooiing (Geschat)

1 juni 2027

Studieregistratiedata

Eerst ingediend

2 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

8 juli 2026

Eerst geplaatst (Werkelijk)

9 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 juli 2026

Laatste update ingediend die voldeed aan QC-criteria