Understanding pain avoidance in people with opioid use disorder
Official title: Opioid Use Disorder and Pain
Run by Yale University · NCT06800703 · Data updated 2026-11-12
This study looks at how people with opioid use disorder learn to avoid pain compared to healthy individuals to better understand their condition.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 21 Years to 60 Years |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Status | Recruiting |
| Started | February 4, 2025 |
| Main results expected | January 2028 |
| Study ends | January 2028 |
| Registry record updated | June 16, 2026 |
| Trial ID | NCT06800703 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals aged 21-60 who meet DSM-5 criteria for moderate to severe opioid use disorder and are currently seeking treatment.
✕Probably not a fit
Patients with significant medical conditions or a history of neurological illness may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to characterize the brain processes involved in pain avoidance learning dysfunctions in individuals with opioid use disorder (OUD). Researchers will compare participants with OUD to healthy controls to assess their ability to learn avoidance behaviors in response to pain. Participants will undergo a learning task while being monitored in an fMRI scanner, and those with OUD will be followed for a year to track future opioid use. The study seeks to uncover the relationship between avoidance learning dysfunction and opioid use, providing insights into the underlying mechanisms of OUD.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment strategies for individuals with opioid use disorder.
How similar studies have gone: While this approach is novel in its focus on pain avoidance learning in OUD, similar studies have explored related aspects of addiction and learning, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Connecticut Mental Health Center, S105
New Haven, Connecticut, United States Recruiting
Study contacts
- Principal investigator: Thang M Le, PhD — Yale University
- Study coordinator: Thang M Le, PhD
- Email: thang.le@yale.edu
- Phone: 203-974-7360
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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CBD for Opioid Dependence and Pain on Buprenorphine
This study tests whether different doses of cannabidiol (CBD) can affect pain and opioid cravings in adults with opioid use disorder who are on buprenorphine, using a short, randomized, placebo-controlled setup.
-
Cebranopadol for opioid withdrawal in adults with chronic pain
This study tests whether cebranopadol can reduce withdrawal symptoms in adults with chronic pain who are physically dependent on prescribed opioids, compared with placebo.
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Imaging Mitochondrial Complex-I and Brain Metabolism in Alcohol Use Disorder
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emPath platform pilot to link and keep adults with opioid use disorder in care in Durham
This pilot tests a mobile app and telemedicine approach to help adults with opioid use disorder start and stay in MOUD through community outreach in Durham, NC.
-
CB1 Receptors in Opioid Use Disorder Measured with a PET Radioligand
This study tests CB1 receptor availability in people with opioid use disorder starting opioid agonist therapy and compares them with healthy adults.
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Vagustim taVNS: Testing a sham in adults for immune-related conditions
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.