NCT06800703 Opioid Use Disorder and Pain

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 180 participants in total. It began in 2025-02-04 with a primary completion date of 2028-01.

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.

Eligibility 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.

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