Actively Recruiting

Age: 21Years - 60Years
All Genders
Healthy Volunteers
NCT06800703

Opioid Use Disorder and Pain

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

180

Participants Needed

1

Research Sites

151 weeks

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

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.

CONDITIONS

Official Title

Opioid Use Disorder and Pain

Who Can Participate

Age: 21Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 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 currently seeking or receiving treatment for OUD (for OUD group)
  • Use non-prescribed opioids weekly or more (for regular opioid users)
  • Physically healthy with no major medical illnesses, history of head injury, or neurological illness
  • No plans to move out of state in the next 12 months
  • Speak English
  • Enrolled in an inpatient or outpatient OUD treatment program for at least 4 weeks (for OUD treatment group)
  • Demographics matching OUD participants (for healthy controls)
  • Able to lie comfortably flat on back for up to 2 hours in MRI scanner
  • Body weight within MRI scanner limit (up to 550 lbs)
Not Eligible

You will not qualify if you...

  • Significant current medical condition such as neurological, cardiovascular, endocrine, renal, hepatic, or thyroid disease
  • History of head injury with loss of consciousness over 30 minutes
  • Current or past major psychiatric disorder (other than opioid or nicotine use disorders) requiring hospitalization or daily medications over 4 weeks
  • Current depressive or anxiety symptoms requiring treatment
  • Presence of foreign ferromagnetic metal objects or other MRI contraindications
  • Previous work in metal industry or with metal shavings posing MRI risk
  • Pregnant or lactating women
  • Unable or unwilling to lie flat in MRI scanner for up to 2 hours
  • Body weight exceeding 550 lbs MRI scanner limit
  • Still experiencing significant withdrawal symptoms
  • History or current Axis I disorder (except nicotine use) for healthy controls

AI-Screening

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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

CONTACT

C

Chiang-shan R Li, MD, PhD

CONTACT

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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