Clinical trial NCT06540105: Leveraging Artificial Intelligence and Multi-Omics Data to Predict Opioid Addiction
Official title: Leveraging Artificial Intelligence and Multi-Omics Data to Predict Opioid Addiction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Opioid Use Disorder
Addiction, Opioid
Keywords: genomics
artificial intelligence
microbiome
opioid use disorder
opioid addiction
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: VA Palo Alto Health Care System
name: San Diego Veterans Healthcare System
First posted: 2024-08-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: opioid use disorder at baseline based on the DSM-5 criteria
timeFrame: baseline
Secondary outcomes:
measure: response to opioid use disorder treatment after 6 months from baseline based on the DSM-5 criteria
timeFrame: 6 months
measure: opioid use disorder remission after 6 months from baseline based on the DSM-5 criteria for remission
timeFrame: 6 months
measure: severity of opioid use disorder at baseline based on the DSM-5 criteria for opioid use disorder
timeFrame: baseline
measure: co-substance use at baseline
timeFrame: baseline
measure: Relapse to opioid use disorder after 6 months from baseline
timeFrame: 6 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Rodney A Gabriel, MD
role: PRINCIPAL_INVESTIGATOR
References: