Klinisk prøve på Opioidbruksforstyrrelse, Opioidforbruk, Vedvarende postkirurgisk smerte, Persistent Opioid Use - Klinisk prøveregister

Studieoversikt

Status

Rekruttering

Forhold

Detaljert beskrivelse

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

Observasjonsmessig

Registrering (Antatt)

100

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Navn: Rodney A Gabriel
Telefonnummer: 858-663-7747
E-post: ragabriel@health.ucsd.edu

Studiesteder

Forente stater
- California
  - La Jolla, California, Forente stater, 92037
    - Rekruttering
    - University of California, San Diego
    - Ta kontakt med:
      
      Rodney A Gabriel
      
      Telefonnummer: 858-663-7747
      
      E-post: ragabriel@health.ucsd.edu
    - Hovedetterforsker:
      
      Rodney A Gabriel

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Voksen
Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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).

Beskrivelse

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)).

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

2

Kohorter og intervensjoner

Gruppe / Kohort
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)

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Persistent Opioid Use Tidsramme: 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

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Pain via Brief Pain Inventory Tidsramme: 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 Tidsramme: 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 Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of California, San Diego

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. juli 2026

Primær fullføring (Antatt)

1. juni 2027

Studiet fullført (Antatt)

1. juni 2027

Datoer for studieregistrering

Først innsendt

2. juli 2026

Først innsendt som oppfylte QC-kriteriene

8. juli 2026

Først lagt ut (Faktiske)

9. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene