Leveraging Artificial Intelligence and Multi-Omics Data to Predict Opioid Addiction (NCT06540105) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Leveraging Artificial Intelligence and Multi-Omics Data to Predict Opioid Addiction
United States300 participantsStarted 2024-08-26
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is no longer recruiting new participants — does that mean there's no chance I could still be considered, or is it worth asking the research team directly?
2Since this trial isn't testing a treatment but instead using AI and multi-omics data to predict opioid addiction, what would actually happen to me as a participant — would I receive any direct care or is it purely data collection?
3The study measures opioid use disorder using DSM-5 criteria at baseline — does that mean my current diagnosis would need to be formally confirmed as part of enrollment, and how might that process affect my existing care?
4Since this is listed as Phase NA, meaning it's an observational or data science study rather than a drug or therapy trial, would participating here delay or interfere with me starting an actual treatment like medication-assisted therapy?
5Could the findings from a study like this one — using AI to identify biological patterns linked to opioid addiction — ever influence my personal treatment plan down the road, or is this research more aimed at helping future patients?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
opioid use disorder at baseline based on the DSM-5 criteria