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Can brain wiring predict opioid relapse? yale launches 240-Person study

NCT ID NCT06651333

Knowledge-focused Sponsor: Yale University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 07, 2026 · Updated 1 time

Summary

This study uses brain scans to understand why some people relapse to opioid use during treatment. Researchers at Yale will follow 240 adults recently started on methadone or buprenorphine, tracking their brain connectivity and drug use for six months. The goal is to identify patterns that predict relapse, not to test a new treatment.

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 240 people

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

Started

Dec 2024

Expected to finish

Nov 2029

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

Participants will be individuals with primary opioid use disorder who are at least 18 years old and enrolled in formal MOUD treatment (either methadone or buprenorphine) for less than 6 months. Investigators will recruit a sample that is 50% female and 50% male.

Ages

18 to 50 years

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: * recent initiation of methadone or buprenorphine at a clinic, program, or doctor within the past year (i.e., period of time during which treatment drop-out and risk for relapse is highest); * eligibility for MRI scanning; * ability to commit to study visits. Exclusion Criteria: * current acute psychosis, mania, or suicidal ideation with intent, as assessed during screening with the SCID-5; * current intoxication or acute withdrawal at time of study visit sufficient to prevent participation based on: behavioral observation, breathalyzer, and SOWS assessment; * severe cognitive impairment as determined via trained clinical research staff through consent process and during consent quiz or as indicated by a PROMIS Cognitive Function tscore \<30 (i.e., severe impairment) * past or present history of intellectual disability, developmental disorder, or neurological disease; * head trauma with loss of consciousness \>30 min; * organ dysfunction or any unstable or untreated medical conditions that may interfere with study participation.

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Conditions

The condition(s) this trial relates to.

opiate dependence opioid abuse Recurrence substance-related disorder

As listed by the trial registrant

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

Drug use disorder Opioid abuse Opioid dependence Opioid use Opioid-related disorders

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hartford Healthcare

    RECRUITING

    Hartford, Connecticut, 06102, United States

  • The APT Foundation

    RECRUITING

    New Haven, Connecticut, 06520, United States

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