Understanding pain avoidance in people with opioid use disorder

Opioid Use Disorder and Pain

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
• Enrollment: 180 (estimated)
• Ages: 21 Years to 60 Years
• Sex: All
• Sponsor: Yale University (Academic / other)
• Locations: 1 site (New Haven, Connecticut)
• Trial ID: NCT06800703 on ClinicalTrials.gov

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.

Who should consider this trial

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.

Not a fit: Patients with significant medical conditions or a history of neurological illness may not benefit from this study.

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 performed: 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.

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.

Where this trial is running

New Haven, Connecticut

• 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

Conditions Opioid Use Disorder; Healthy Controls Group - Age and Sex-matched; opioid use disorder; pain; avoidance learning; prediction