Opioid Use DisorderNCT06540105
Leveraging Artificial Intelligence and Multi-Omics Data to Predict Opioid Addiction
An observational study of Opioid Use Disorder and Addiction, Opioid, run by University of California, San Diego at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder, Addiction, Opioid
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2024to 30 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- diagnosis of OUD (active or in remission) defined by the DSM-5 criteria
- age ≥ 18 years old
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
La Jolla, California, 92037
About this study
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.
Read the 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).
- Conditions
- Opioid Use Disorder, Addiction, Opioid
- Keywords
- genomics, artificial intelligence, microbiome, opioid use disorder, opioid addiction
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Opioid Use Disorder | Subjects with a history of opioid use disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: baseline
co-substance use at baseline
risk of developing co-substance use disorder based on DSM-5 criteria for substance use disorders
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start26 Aug 2024
- Primary completion29 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- VA Palo Alto Health Care System, San Diego Veterans Healthcare System
- Responsible party
- Principal investigator, Rodney Gabriel, University of California, San Diego
- Investigators
- Rodney A Gabriel, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06540105
- Sponsor's protocol ID
- 810491
- Status last verified
- Jun 2026
- First submitted
- 29 Jul 2024
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A publicly available biobank with be developed with de-identified data that may be shared with external researchers after approval.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Artificial Intelligence and Multi-Omics Data to Predict Opioid Addiction
- ClinicalTrials.gov ID
- NCT06540105
- Acronym / sponsor ID
- 810491
- Conditions
- Opioid Use Disorder, Addiction, Opioid
- Keywords
- genomics, artificial intelligence, microbiome, opioid use disorder, opioid addiction
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- VA Palo Alto Health Care System, San Diego Veterans Healthcare System
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- 29 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Opioid Use Disorder | – | –Subjects with a history of opioid use disorder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- diagnosis of OUD (active or in remission) defined by the DSM-5 criteria
- age ≥ 18 years old
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
opioid use disorder at baseline based on the DSM-5 criteria
Time frame: baseline
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
5 secondary outcomes
response to opioid use disorder treatment after 6 months from baseline based on the DSM-5 criteria
Time frame: 6 months
opioid use disorder remission after 6 months from baseline based on the DSM-5 criteria for remission
Time frame: 6 months
severity of opioid use disorder at baseline based on the DSM-5 criteria for opioid use disorder
Time frame: baseline
co-substance use at baseline
Time frame: baseline
Relapse to opioid use disorder after 6 months from baseline
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: Yes. A publicly available biobank with be developed with de-identified data that may be shared with external researchers after approval.
Related trials for Opioid Use Disorder
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Pain Sensitivity, Alcohol-Induced Analgesia, and Heavy Drinking in Individuals With Opioid Use Disorder
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Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
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Cannabis Use and Outcomes in Black and White Patients With Cancer
Cancer
RecruitingObservational study
Outcome Inference in the Sensory Preconditioning Task in Opioid-Use Disorder
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Active, not recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodney A Gabriel, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Use Disorder and Addiction, Opioid, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
opioid use disorder at baseline based on the DSM-5 criteria (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.