Leveraging Artificial Intelligence and Multi-Omics Data to Predict Opioid Addiction

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT06540105
Status
Recruiting
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Conditions

  • Addiction, Opioid
  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

The primary goal of this proposal is to validate a novel genomic and microbiome predictive model that may be used to assess a person's risk of developing opioid use disorder (OUD). The following will be tested: (1) MODUS (Measuring risk for Opioid use Disorder Using SNPs), which is a genomic panel consisting of a set number of proven single nucleotide polymorphisms (SNP) that utilizes machine learning to determine an individual's risk; and (2) MICROUD (MICRObiome for Opioid Use Disorder), which will be a novel microbiome prediction panel for OUD risk. MODUS and MICROUD will be developed using existing public datasets with genomic and microbiome data (e.g., All of Us, Human Microbiome Project). During development of these predictive models, in parallel, an external prospective validation cohort will be recruited consisting of subjects from the University of California, San Diego, Veteran Affairs of San Diego, and Veteran Affairs of Palo Alto (each site with separate IRB). The hypothesis is that MODUS and MICROUD will have high predictive potential for identifying high risk patients for OUD.

Key Dates

Start date
Aug 26, 2024
Status verified
Aug 2024
Primary completion
Jun 29, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Opioid Use Disorder
    Subjects with a history of opioid use disorder

Primary Outcome Measure

opioid use disorder at baseline based on the DSM-5 criteria [ Time Frame: baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San DiegoLa JollaCalifornia92037
Rodney Gabriel, MD, MAS
[email protected]
8586637747
Brandon Palugod, BS
[email protected]
Rodney A Gabriel, MD, MAS

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