RECRUITING

Opioid Use Disorder and Pain

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Opioid Use Disorder and Pain

Quick Facts

Study Start:2025-02-04
Study Completion:2028-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06800703

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 1. Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, hepatic, thyroid pathology.
  2. 2. History of head injury with loss of consciousness (\> 30 minutes).
  3. 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. 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. 5. Pregnant or lactating women will not be recruited for the study.
  6. 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. 7. Body weight \> 550 lbs. The MR scanner bed is tested to a weight limit of 550 lbs.
  8. 8. No pPlans to relocate out of state in the next 12 months (for follow-up purposes).
  9. 9. Still experiencing significant withdrawal symptoms.
  10. 1. Between ages 21-60 years old.
  11. 2. Able to read and write and provide written informed consent.
  12. 3. Use non-prescribed opioids on a weekly basis or more.
  13. 4. Physically healthy with no major medical illnesses, history of head injury or any neurological illness
  14. 5. No plans to relocate out of state in the next 12 months (for follow-up purposes).
  15. 6. Speak English

Contacts and Locations

Study Contact

Thang M Le, PhD
CONTACT
203-974-7360
thang.le@yale.edu
Chiang-shan R Li, MD, PhD
CONTACT
203-974-7354
chiang-shan.li@yale.edu

Principal Investigator

Thang M Le, PhD
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

Connecticut Mental Health Center, S105
New Haven, Connecticut, 06519
United States

Collaborators and Investigators

Sponsor: Yale University

  • Thang M Le, PhD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-04
Study Completion Date2028-01

Study Record Updates

Study Start Date2025-02-04
Study Completion Date2028-01

Terms related to this study

Keywords Provided by Researchers

  • opioid use disorder
  • pain
  • avoidance learning
  • prediction

Additional Relevant MeSH Terms

  • Opioid Use Disorder
  • Healthy Controls Group - Age and Sex-matched