Recruiting

Observational Study

Sponsor:

Yale University

Code:

NCT06800703

Conditions

Opioid Use Disorder

Healthy Controls Group - Age and Sex-matched

Eligibility Criteria

Sex: All

Age: 21 - 60

Healthy Volunteers: Accepted

Interventions

follow up interviews for 12 months to determine opioid use

Study Details

Brief summary:

The goal of this observational study is to characterize the brain processes of pain avoidance learning dysfunctions in individuals with opioid use disorder (OUD). The main questions it aims to answer are:

Compared with healthy controls, do those with OUD exhibit impaired avoidance learning in response to pain? What are the brain processes that are associated with this avoidance learning dysfunction? Do these brain processes serve to predict future use or relapse?

Researchers will compare those with OUD and healthy controls to determine avoidance learning dysfunction and its relationship with opioid use.

Participants will be performing a learning task inside an fMRI scanner. Those with OUD will also be followed up for a year to determine future opioid use.

Conditions

Opioid Use Disorder

Healthy Controls Group - Age and Sex-matched

Study ID

NCT06800703

Start date

Feb 4, 2025

Status verified date

Jun, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 60

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

180 participants

Anticipated

Interventions and Outcome Measures

Arms

opioid use disorder

individuals with OUD diagnosis

Healthy controls

Healthy individuals without substance use disorders

Interventions

follow up interviews for 12 months to determine opioid use

Follow-up

Primary outcome measure

  • Avoidance learning measure [ Time Frame: Day 1 (immediately after consent and clinical assessment) ]
  • opioid use [ Time Frame: During the 12-month follow-up period ]
  • Brain activity during avoidance learning [ Time Frame: Day 1 (immediately after consent and clinical assessment) ]

Central Contacts and Locations

Central contacts

Locations

Connecticut Mental Health Center, S105

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

More Information

Sponsor

Yale University

Last update posted

Jun 16, 2026

Last verified

Jun, 2026

Keywords

  • opioid use disorder
  • pain
  • avoidance learning
  • prediction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-06-16.