NCT06800703 · Yale University
Opioid Use Disorder and Pain
What this study is about
The goal of this observational study is to characterize the brain processes of pain avoidance learning dysfunctions in individuals with opioid use disorder (OUD).
View original scientific description
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.
Interventions
BEHAVIORAL
follow up interviews for 12 months to determine opioid use
Follow-up
Primary outcome measures
Avoidance learning measure
Time frame: Day 1 (immediately after consent and clinical assessment)
Task performance measure of avoidance learning, quantified by response time and performance accuracy. Those with OUD are expected to have lower performance accuracy, lower learning rates, and higher response time during avoidance learning relative to healthy controls
opioid use
Time frame: During the 12-month follow-up period
Quantity of opioid use following the baseline visit, measured by times use per week. Timeline follow back method will be used to assess the quantity of opioid use during the follow-up period. The investigators will examine this opioid use quantity in relation with avoidance learning deficits. The investigators expect greater avoidance dysfunction at baseline to predict higher weekly use of opioids
Brain activity during avoidance learning
Time frame: Day 1 (immediately after consent and clinical assessment)
The brain activation magnitude associated with avoidance learning and avoidance learning dysfunction during the task performance. Brain activation will be computed by using contrast between avoidance learning vs. neutral conditions. Contrasts between two subject groups (i.e., OUD vs. HC) will also be examined. The investigators expect OUD patients to exhibit greater activations in the pain circuit during avoidance learning relative to healthy controls. Additionally, pain circuit activation will be assessed in association with opioid use severity during follow-up period.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- in the study, an individual must meet all of the following criteria:
- Between ages 21-60 years old.
- Able to read and write and provide written informed consent.
- 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.
- Physically healthy with no major medical illnesses, history of head injury or any neurological illness
- No plans to relocate out of state in the next 12 months (for follow-up purposes).
- Currently seeking treatment or currently receiving treatment for OUD.
- Speak English
- Have been enrolled in an inpatient or outpatient treatment program for OUD for at least 4 weeks.
Exclusion criteria
- Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, hepatic, thyroid pathology.
- History of head injury with loss of consciousness (\> 30 minutes).
- 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.
- 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).
- Pregnant or lactating women will not be recruited for the study.
- Cannot or are not willing to lie comfortably flat on his/her back for up to 2 hours in the MRI scanner (self-report).
- Body weight \> 550 lbs. The MR scanner bed is tested to a weight limit of 550 lbs.
- No pPlans to relocate out of state in the next 12 months (for follow-up purposes).
- 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:
- Between ages 21-60 years old.
- Able to read and write and provide written informed consent.
- Use non-prescribed opioids on a weekly basis or more.
- Physically healthy with no major medical illnesses, history of head injury or any neurological illness
- No plans to relocate out of state in the next 12 months (for follow-up purposes).
- Speak English Exclusion Criteria:
- Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, hepatic, thyroid pathology.
- History of head injury with loss of consciousness (\> 30 minutes).
- 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.
- Any subjects with foreign ferromagnetic metal objects in their body or other MR contraindications will be excluded.
- Pregnant or lactating women will not be recruited for the study.
- Cannot or are not willing to lie comfortably flat on his/her back for up to 2 hours in the MRI scanner (self-report).
- 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:
- Between ages 21-60 years old.
- Able to read and write and provide written informed consent.
- Use non-prescribed opioids on a weekly basis or more.
- Physically healthy with no major medical illnesses, history of head injury or any neurological illness
- No plans to relocate out of state in the next 12 months (for follow-up purposes).
- Speak English Exclusion Criteria:
- Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, hepatic, thyroid pathology.
- History of head injury with loss of consciousness (\> 30 minutes).
- 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.
- Any subjects with foreign ferromagnetic metal objects in their body or other MR contraindications will be excluded.
- Pregnant or lactating women will not be recruited for the study.
- Cannot or are not willing to lie comfortably flat on his/her back for up to 2 hours in the MRI scanner (self-report).
- 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:
- Between ages 21-60 years old.
- Able to read and write and provide written informed consent.
- Use non-prescribed opioids on a weekly basis or more.
- Physically healthy with no major medical illnesses, history of head injury or any neurological illness
- No plans to relocate out of state in the next 12 months (for follow-up purposes).
- Speak English Exclusion Criteria:
- Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, hepatic, thyroid pathology.
- History of head injury with loss of consciousness (\> 30 minutes).
- 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.
- Any subjects with foreign ferromagnetic metal objects in their body or other MR contraindications will be excluded.
- Pregnant or lactating women will not be recruited for the study.
- Cannot or are not willing to lie comfortably flat on his/her back for up to 2 hours in the MRI scanner (self-report).
- Body weight \> 550 lbs. The MR scanner bed is tested to a weight limit of 550 lbs. Healthy controls (HC) Inclusion Criteria
- Between ages 1821-60 years old.
- Able to read and write and provide written informed consent.
- Demographics matching OUD participants.
- Speak English Exclusion Criteria:
- Meet criteria for current or history of any Axis I (except nicotine use) disorder.
- 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
- New Haven, Connecticut
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 16, 2026 · Source of record for eligibility and locations