Opioid Use Disorder and Pain (NCT06800703) | Clinical Trial Compass
RecruitingNot Applicable
Opioid Use Disorder and Pain
United States180 participantsStarted 2025-02-04
Plain-language summary
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.
Who can participate
Age range
21 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. No plans to relocate out of state in the next 12 months (for follow-up purposes).
. Currently seeking treatment or currently receiving treatment for OUD.
. Speak English
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Avoidance learning measure
Timeframe: Day 1 (immediately after consent and clinical assessment)
2
opioid use
Timeframe: During the 12-month follow-up period
3
Brain activity during avoidance learning
Timeframe: Day 1 (immediately after consent and clinical assessment)
. Have been enrolled in an inpatient or outpatient treatment program for OUD for at least 4 weeks.
Exclusion criteria
. 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).
. Pregnant or lactating women will not be recruited for the study.
. Cannot or are not willing to lie comfortably flat on his/her back for up to 2 hours in the MRI scanner (self-report).
. Body weight \> 550 lbs. The MR scanner bed is tested to a weight limit of 550 lbs.
. No pPlans to relocate out of state in the next 12 months (for follow-up purposes).