RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-08-26
Study Completion:2027-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06540105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * diagnosis of OUD (active or in remission) defined by the DSM-5 criteria
  2. * age ≥ 18 years old
  1. * inability to participate independently with the study (i.e. dementia)
  2. * chronic opioid use that is not consistent with a diagnosis of OUD
  3. * patients that are pregnant
  4. * children
  5. * institutionalized individuals
  6. * 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.

Contacts and Locations

Study Contact

Rodney A Gabriel, MD
CONTACT
8586637747
ragabriel@health.ucsd.edu
Sesh Mudumbai, MD
CONTACT
mudumbai@stanford.edu

Principal Investigator

Rodney A Gabriel, MD
PRINCIPAL_INVESTIGATOR
University of California, San Diego

Study Locations (Sites)

University of California, San Diego
La Jolla, California, 92037
United States

Collaborators and Investigators

Sponsor: University of California, San Diego

  • Rodney A Gabriel, MD, PRINCIPAL_INVESTIGATOR, University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-26
Study Completion Date2027-09-30

Study Record Updates

Study Start Date2024-08-26
Study Completion Date2027-09-30

Terms related to this study

Keywords Provided by Researchers

  • genomics
  • artificial intelligence
  • microbiome
  • opioid use disorder
  • opioid addiction

Additional Relevant MeSH Terms

  • Opioid Use Disorder
  • Addiction, Opioid