Health Trials

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • follow up interviews for 12 months to determine opioid use

Treatment groups

180 Participants
are divided into 2 treatment groups

Locations

1
Connecticut Mental Health Center, S10506519, New HavenConnecticut, United States

Sponsors and collaborators

Yale University

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Source ClinicalTrials.gov