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

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.

Study Overview

• Status: Recruiting
• Conditions: Opioid Use Disorder; Addiction, Opioid

Detailed Description

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.

Specific Aim 1. Validate a novel genomic predictive panel assay - termed MODUS - in a prospective observational study that aims to recruit 300 subjects (~200 from UCSD and VA San Diego) with a history of OUD. This genomic panel will be developed separately but then validated on the study population. Healthy control data will be used from a publicly-available de-identified genomic dataset (All of Us Research Program) .

Specific Aim 2. Validate a novel microbiome predictive panel assay - termed MICROUD - in a prospective observational study that aims to recruit 300 subjects (~200 from UCSD and VA San Diego) with a history of OUD. This microbiome panel will be developed separately but then validated on the study population. Healthy control data will be used from a publicly-available de-identified microbiome dataset (Human Microbiome Project).

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Rodney A Gabriel, MD; Phone Number: 8586637747; Email: ragabriel@health.ucsd.edu
• Study Contact Backup: Name: Sesh Mudumbai, MD; Email: mudumbai@stanford.edu

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Recruiting
      • University of California, San Diego
      • Contact: Rodney Gabriel, MD, MAS; Phone Number: 8586637747; Email: ragabriel@health.ucsd.edu
      • Contact: Brandon Palugod, BS; Email: bmpalugod@health.ucsd.edu
      • Contact: Rodney A Gabriel, MD, MAS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

For the prospective observational study described , adult subjects (≥18 years old) will be recruited with active or previous history of opioid addiction from various clinical settings, including chronic pain clinics, emergency department, operating room, addiction clinics, family medicine/primary care clinics, and surgical clinics

Description

Inclusion Criteria:

• diagnosis of OUD (active or in remission) defined by the DSM-5 criteria
• age ≥ 18 years old

Exclusion Criteria:

• inability to participate independently with the study (i.e. dementia)
• chronic opioid use that is not consistent with a diagnosis of OUD
• patients that are pregnant
• children
• institutionalized individuals
• non-English speaking subjects as there are several surveys without appropriate translation and with sensitive information (e.g., questions about mental health and history of drug use) that is required to complete the study.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Opioid Use Disorder; Subjects with a history of opioid use disorder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
opioid use disorder at baseline based on the DSM-5 criteria	risk of opioid use disorder based on genomics, social determinants of health, microbiome, and other clinical data. Patients with OUD will be enrolled and compared to healthy controls using data from external datasets such as NIH All of Us Research Program. Diagnosis of opioid use disorder will be based on the DSM-5 criteria for opioid use disorder	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
response to opioid use disorder treatment after 6 months from baseline based on the DSM-5 criteria	prediction of response to opioid use disorder treatment. Remission from opioid use disorder will be based on DSM-5 criteria for remission from substance use disorder	6 months
opioid use disorder remission after 6 months from baseline based on the DSM-5 criteria for remission	prediction of remission of opioid use disorder based on the DSM-5 criteria for remission from substance use disorder	6 months
severity of opioid use disorder at baseline based on the DSM-5 criteria for opioid use disorder	prediction of severity of opioid use disorder based on the DSM-5 criteria for opioid use disorder	baseline
co-substance use at baseline	risk of developing co-substance use disorder based on DSM-5 criteria for substance use disorders	baseline
Relapse to opioid use disorder after 6 months from baseline	risk of relapse to opioid use disorder based on DSM-5 criteria for opioid use disorder	6 months

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: VA Palo Alto Health Care System; San Diego Veterans Healthcare System
• Investigators: Principal Investigator: Rodney A Gabriel, MD, University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2024
• Primary Completion (Estimated): June 29, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: July 29, 2024
• First Submitted That Met QC Criteria: August 1, 2024
• First Posted (Actual): August 6, 2024

Study Record Updates

• Last Update Posted (Actual): September 20, 2024
• Last Update Submitted That Met QC Criteria: September 18, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: genomics; artificial intelligence; opioid use disorder; microbiome; opioid addiction
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Compulsive Behavior; Impulsive Behavior; Opioid-Related Disorders; Behavior, Addictive
• Other Study ID Numbers: 810491

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A publicly available biobank with be developed with de-identified data that may be shared with external researchers after approval.
• IPD Sharing Time Frame: after conclusion of the study for indeterminate amount of time
• IPD Sharing Access Criteria: appropriate data use agreement and IRB approval
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No