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

NCT06540105 | Recruiting

• 1 other identifier: 810491
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opioid Use Disorder; Addiction, Opioid

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• response to opioid use disorder treatment after 6 months from baseline based on the DSM-5 criteria

  6 months

• opioid use disorder remission after 6 months from baseline based on the DSM-5 criteria for remission

  6 months

• severity of opioid use disorder at baseline based on the DSM-5 criteria for opioid use disorder

  baseline

• co-substance use at baseline

  baseline

• Relapse to opioid use disorder after 6 months from baseline

  6 months

Study Arms (1)

Opioid Use Disorder

Subjects with a history of opioid use disorder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• VA Palo Alto Health Care System: collaborator
• San Diego Veterans Healthcare System: collaborator

Study Sites (1)

University of California, San Diego

La Jolla, California, 92037, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

saliva for DNA sequencing, stool sample for microbiome analyses and blood/plasma for metabolomic analyses

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Rodney A Gabriel, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodney A Gabriel, MD

CONTACT

8586637747; ragabriel@health.ucsd.edu

Sesh Mudumbai, MD

CONTACT

mudumbai@stanford.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 6, 2024
• Study Start: August 26, 2024
• Primary Completion (Estimated): June 29, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: September 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: after conclusion of the study for indeterminate amount of time
• Access Criteria: appropriate data use agreement and IRB approval

Locations

US (1)