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Brain scans may predict opioid relapse risk

NCT ID NCT06800703

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This observational study at Yale University aims to understand how people with opioid use disorder (OUD) learn to avoid pain compared to healthy individuals. About 180 participants will perform a learning task inside an fMRI scanner to measure brain activity. Those with OUD will also be followed for a year to track their opioid use, helping researchers see if brain patterns can predict future use or relapse.

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 study could reveal brain patterns that predict opioid relapse, pointing toward new behavioral or brain-based treatments.
What could go wrong
This is an early observational study, not a treatment trial. It may not lead to direct therapies, and results may not apply to all people with opioid use disorder.

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 180 people

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

Started

Feb 2025

Expected to finish

Jan 2028

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

Treatment-seeking OUD patients will be recruited from local clinics. Those with OUD not seeking treatment and healthy controls will be recruited from New Haven and surrounding areas in Connecticut.

Ages

21 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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.

Patients with Opioid Use Disorder (OUD) To be eligible for inclusion in the study, an individual must meet all of the following criteria: 1. Between ages 21-60 years old. 2. Able to read and write and provide written informed consent. 3. Meet DSM-5 criteria for moderate to severe opioid use disorder; self-reported excessive opioid use prior to study entry and verified by urine toxicology testing; seeking treatment for their OUD. 4. Physically healthy with no major medical illnesses, history of head injury or any neurological illness 5. No plans to relocate out of state in the next 12 months (for follow-up purposes). 6. Currently seeking treatment or currently receiving treatment for OUD. 7. Speak English 8. Have been enrolled in an inpatient or outpatient treatment program for OUD for at least 4 weeks. Exclusion Criteria: 1. Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, hepatic, thyroid pathology. 2. History of head injury with loss of consciousness (\> 30 minutes). 3. Current or past DSM-IV or DSM 5 diagnosis of a major psychiatric disorder (other than opioid and nicotine use disorders) that required hospitalization, or that required daily medications for over 4 weeks. Such medications include antidepressants, anticholinergics, antipsychotics, anxiolytics, lithium, psychotropic drugs not otherwise specified including herbal products, drugs with psychomotor effects or with anxiolytics, stimulant, or antipsychotic properties, any other psychoactive drugs, and sedatives/hypnotics. Individuals with current depressive or anxiety symptoms requiring treatment or currently being treated for these symptoms will be excluded. 4. Any subjects with foreign ferromagnetic metal objects in their body or other MR contraindications will be excluded. Individuals who previously worked in metal industry or with metal shavings (due to a risk of any remaining metal particles moving in the eye during the MRI). 5. Pregnant or lactating women will not be recruited for the study. 6. Cannot or are not willing to lie comfortably flat on his/her back for up to 2 hours in the MRI scanner (self-report). 7. Body weight \> 550 lbs. The MR scanner bed is tested to a weight limit of 550 lbs. 8. No pPlans to relocate out of state in the next 12 months (for follow-up purposes). 9. Still experiencing significant withdrawal symptoms. Individuals with regular opioid use To be eligible for inclusion in the study, an individual must meet all of the following criteria: 1. Between ages 21-60 years old. 2. Able to read and write and provide written informed consent. 3. Use non-prescribed opioids on a weekly basis or more. 4. Physically healthy with no major medical illnesses, history of head injury or any neurological illness 5. No plans to relocate out of state in the next 12 months (for follow-up purposes). 6. Speak English Exclusion Criteria: 1. Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, hepatic, thyroid pathology. 2. History of head injury with loss of consciousness (\> 30 minutes). 3. Current or past DSM-IV or DSM 5 diagnosis of a major psychiatric disorder (other than opioid and nicotine use disorders) that required hospitalization, or that required daily medications for over 4 weeks. Such medications include antidepressants, anticholinergics, antipsychotics, anxiolytics, lithium, psychotropic drugs not otherwise specified including herbal products, drugs with psychomotor effects or with anxiolytics, stimulant, or antipsychotic properties, any other psychoactive drugs, and sedatives/hypnotics. Individuals with current depressive or anxiety symptoms requiring treatment or currently being treated for these symptoms will be excluded. 4. Any subjects with foreign ferromagnetic metal objects in their body or other MR contraindications will be excluded. 5. Pregnant or lactating women will not be recruited for the study. 6. Cannot or are not willing to lie comfortably flat on his/her back for up to 2 hours in the MRI scanner (self-report). 7. Body weight \> 550 lbs. The MR scanner bed is tested to a weight limit of 550 lbs. Individuals with regular opioid use To be eligible for inclusion in the study, an individual must meet all of the following criteria: 1. Between ages 21-60 years old. 2. Able to read and write and provide written informed consent. 3. Use non-prescribed opioids on a weekly basis or more. 4. Physically healthy with no major medical illnesses, history of head injury or any neurological illness 5. No plans to relocate out of state in the next 12 months (for follow-up purposes). 6. Speak English Exclusion Criteria: 1. Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, hepatic, thyroid pathology. 2. History of head injury with loss of consciousness (\> 30 minutes). 3. Current or past DSM-IV or DSM 5 diagnosis of a major psychiatric disorder (other than opioid and nicotine use disorders) that required hospitalization, or that required daily medications for over 4 weeks. Such medications include antidepressants, anticholinergics, antipsychotics, anxiolytics, lithium, psychotropic drugs not otherwise specified including herbal products, drugs with psychomotor effects or with anxiolytics, stimulant, or antipsychotic properties, any other psychoactive drugs, and sedatives/hypnotics. Individuals with current depressive or anxiety symptoms requiring treatment or currently being treated for these symptoms will be excluded. 4. Any subjects with foreign ferromagnetic metal objects in their body or other MR contraindications will be excluded. 5. Pregnant or lactating women will not be recruited for the study. 6. Cannot or are not willing to lie comfortably flat on his/her back for up to 2 hours in the MRI scanner (self-report). 7. Body weight \> 550 lbs. The MR scanner bed is tested to a weight limit of 550 lbs. Individuals with regular opioid use To be eligible for inclusion in the study, an individual must meet all of the following criteria: 1. Between ages 21-60 years old. 2. Able to read and write and provide written informed consent. 3. Use non-prescribed opioids on a weekly basis or more. 4. Physically healthy with no major medical illnesses, history of head injury or any neurological illness 5. No plans to relocate out of state in the next 12 months (for follow-up purposes). 6. Speak English Exclusion Criteria: 1. Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, hepatic, thyroid pathology. 2. History of head injury with loss of consciousness (\> 30 minutes). 3. Current or past DSM-IV or DSM 5 diagnosis of a major psychiatric disorder (other than opioid and nicotine use disorders) that required hospitalization, or that required daily medications for over 4 weeks. Such medications include antidepressants, anticholinergics, antipsychotics, anxiolytics, lithium, psychotropic drugs not otherwise specified including herbal products, drugs with psychomotor effects or with anxiolytics, stimulant, or antipsychotic properties, any other psychoactive drugs, and sedatives/hypnotics. Individuals with current depressive or anxiety symptoms requiring treatment or currently being treated for these symptoms will be excluded. 4. Any subjects with foreign ferromagnetic metal objects in their body or other MR contraindications will be excluded. 5. Pregnant or lactating women will not be recruited for the study. 6. Cannot or are not willing to lie comfortably flat on his/her back for up to 2 hours in the MRI scanner (self-report). 7. Body weight \> 550 lbs. The MR scanner bed is tested to a weight limit of 550 lbs. Healthy controls (HC) Inclusion Criteria 1. Between ages 1821-60 years old. 2. Able to read and write and provide written informed consent. 3. Demographics matching OUD participants. 4. Speak English Exclusion Criteria: 1. Meet criteria for current or history of any Axis I (except nicotine use) disorder. 2. Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, hepatic, thyroid pathology. History of head injury with loss of consciousness (\> 30 minutes). 4\. Any subjects with foreign ferromagnetic metal objects in their body or other MR contraindications will be excluded. 5\. Pregnant or lactating women will not be recruited for the study. 6. Cannot or are not willing to lie comfortably flat on his/her back for up to 2 hours in the MRI scanner (self-report). 7\. Body weight \> 550 lbs. The MR scanner bed is tested to a weight limit of 550 lbs.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    1 site. 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

  • Connecticut Mental Health Center, S105

    RECRUITING

    New Haven, Connecticut, 06519, United States

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