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AI and gut bacteria may predict who gets hooked on opioids

NCT ID NCT06540105

Knowledge-focused Sponsor: University of California, San Diego Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times

Summary

This study aims to validate two new tools that use artificial intelligence to predict a person's risk of developing opioid use disorder. One tool looks at genetic markers, and the other examines gut bacteria. Researchers will enroll 300 adults with or without opioid addiction to see how well these tools work.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a simple test to identify people at high risk for opioid addiction before it starts.
What could go wrong
This is an early validation study, not a treatment trial. The predictive models may not work well in real-world settings or for all populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

opiate dependence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Addiction, opioid Opioid-use disorder

Contacts and locations

Locations

  • University of California, San Diego

    La Jolla, California, 92037, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.