Actively Recruiting

Age: 21Years - 60Years
All Genders
Healthy Volunteers
ID06800703

Opioid Use Disorder and Pain: Brain Processes of Pain Avoidance Learning and 12-Month Follow-Up of Opioid Use

Led by Yale University · Updated on 2025-02-28

180

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

Y

Yale University

Lead Sponsor

N

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating how brain processes related to pain avoidance learning may be different in individuals with opioid use disorder (OUD) compared to healthy people. The study explores whether those with OUD have trouble learning to avoid pain and how this relates to their brain activity. It also aims to find out if these brain processes can predict future opioid use or relapse in people with OUD. Participants include individuals diagnosed with OUD who are seeking treatment, regular opioid users not seeking treatment, and healthy controls matched by age, sex, race, and education. Participants will perform a learning task inside an fMRI scanner to assess avoidance and reward learning through a probabilistic go/no-go task involving cues to avoid electric shocks or gain rewards. The study includes a 12-month follow-up period for those with OUD to monitor opioid use and relapse. During the study, participants undergo clinical assessments, neuroimaging, and physiological recordings on the first day. The primary outcomes measured include avoidance learning performance, brain activity during the learning task, and opioid use over the 12-month follow-up. Secondary outcomes compare learning and brain activity differences between women and men. Participants must be physically healthy and able to complete study tasks, with safety monitoring such as MRI compatibility checks. The total participation period includes initial testing and one year of follow-up for opioid use monitoring.

CONDITIONS

Brief Title

Opioid Use Disorder and Pain

Who Can Participate

Age: 21Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Between ages 21 and 60 years old
  • Able to read and write and provide written informed consent
  • Meet DSM-5 criteria for moderate to severe opioid use disorder and be seeking treatment
  • Physically healthy with no major medical illnesses, history of head injury, or neurological illness
  • No plans to relocate out of state in the next 12 months
  • Currently enrolled in or receiving inpatient or outpatient treatment for opioid use disorder for at least 4 weeks
  • Speak English
  • Regular opioid users must use non-prescribed opioids weekly or more
  • Healthy controls must match demographics of OUD participants and speak English
Not Eligible

You will not qualify if you...

  • Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, hepatic, or thyroid pathology
  • History of head injury with loss of consciousness greater than 30 minutes
  • Current or past diagnosis of major psychiatric disorders (other than opioid and nicotine use disorders) requiring hospitalization or daily medications over 4 weeks
  • Use of antidepressants, antipsychotics, anxiolytics, lithium, psychotropic drugs, sedatives/hypnotics, or herbal products with psychomotor or anxiolytic effects
  • Pregnant or lactating women
  • Presence of foreign ferromagnetic metal objects incompatible with MRI
  • Inability or unwillingness to lie flat for up to 2 hours in MRI scanner
  • Body weight over 550 lbs
  • Still experiencing significant withdrawal symptoms
  • Plans to relocate out of state in the next 12 months for follow-up purposes

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo neuroimaging, physiological recordings, and clinical assessments to evaluate avoidance and reward learning related to opioid use disorder.

1 baseline visit (in-person)

Long-term Monitoring

Duration - 12 months

Participants are followed up for 12 months to monitor opioid use and identify predictors of relapse.

Follow-up interviews during the 12-month period

Trial Site Locations

Total: 1 location

1

Connecticut Mental Health Center, S105

New Haven, Connecticut, United States, 06519

Actively Recruiting

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Research Team

T

Thang M Le, PhD

C

Chiang-shan R Li, MD, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Heart Rate Variability, Cue-Evoked Ventromedial Prefrontal Cortical Response, and Problem Alcohol Use in Adult Drinkers.

Wuyi Wang, Simon Zhornitsky, Thang M Le...

https://pubmed.ncbi.nlm.nih.gov/32061544