Adversity, Brain and Opioid Use Study (NCT06355778) | Clinical Trial Compass
RecruitingNot Applicable
Adversity, Brain and Opioid Use Study
United States185 participantsStarted 2025-01-09
Plain-language summary
The way people process and remember information may be related to adverse childhood experiences and Opioid Use Disorder symptoms. The purpose of this project is to examine brain function and performance during learning and memory tasks in adults. The study will compare measures of learning and memory across three groups of participants: those with an Opioid Use Disorder (OUD) that take buprenorphine for opioid replacement therapy, adults without an Opioid Use Disorder taking buprenorphine, and healthy adults that do not have an Opioid Use Disorder and are not taking buprenorphine.
Who can participate
Age range
18 Years – 55 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 for all groups:
* Right handed
* Able to give informed consent
* Normal/corrected-to-normal vision and hearing
Inclusion Criteria for Opioid Use Disorder (OUD) group:
* Diagnosis of OUD
* Be actively receiving buprenorphine (BUP) for opioid agonist therapy
* Be free from illicit substance use for at least 2 weeks
* The study will allow stable dose (\> 3 months) of commonly prescribed psychiatric medications and some sleep aids (per protocol)
Inclusion Criteria for the BUP control group:
* Taking BUP for chronic pain
* No Substance Use Disorder (including OUD)
* The study will allow stable dose (\> 3 months) of commonly prescribed psychiatric medications and some sleep aids (per protocol)
Inclusion Criteria for Healthy participant group:
* Not taking BUP
* Free of any psychiatric or major medical conditions
Exclusion Criteria for all groups:
* Significant medical or neurologic conditions (e.g., stroke, seizures, multiple sclerosis)
* Actively suicidal
* Contraindication for MRI
* Inability to tolerate small, enclosed spaces without anxiety
* Life history of schizophrenia, bipolar disorder, learning disability, attention deficit disorder, or pervasive developmental disorder
* Use of substances or prescription medications that could interfere with measures of interest (per protocol)
* Unable to provide informed consent
* Participants who have completed other studies in our lab involving learning and memory assessments with the same/similar tasks used …
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
Differences in Blood Oxygen Level Dependent (BOLD) signal in the hippocampus
Timeframe: Day 2 (MRI task visit)
2
Differences in Hippocampal (Hpc) volume
Timeframe: Day 2 (MRI task visit)
3
Differences in hippocampal circuit connectivity
Timeframe: Day 2 (MRI task visit)
4
Differences in performance
Timeframe: Day 1 (computer tasks visit)
5
Differences in performance
Timeframe: Day 2 (MRI task visit)
6
Differences in threat reactivity measured via skin conductance response (SCR)
Timeframe: Day 1 (computer tasks visit)
7
Differences in threat reactivity measured via skin conductance response (SCR)