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.
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
300
University of California, San Diego
La Jolla, California, United States
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
Time frame: baseline
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
Time frame: 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
Time frame: 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
Time frame: baseline
co-substance use at baseline
risk of developing co-substance use disorder based on DSM-5 criteria for substance use disorders
Time frame: 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
Time frame: 6 months
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