NCT06355778 · University of Michigan
Adversity, Brain and Opioid Use Study
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
Magnetic Resonance Imaging (MRI)
Enrolled participants will have one MRI during the study on day 2 after having Day 1 visit. During the MRI the participants will complete various tasks.
BEHAVIORAL
Computer Tasks
Eligible participants will complete computer tasks (cognitive tasks, spatial navigation tasks, context dependent fear learning, etc.) at visit 1 and then during the MRI.
Primary outcome measures
Differences in Blood Oxygen Level Dependent (BOLD) signal in the hippocampus
Time frame: Day 2 (MRI task visit)
BOLD signal during functional magnetic resonance imaging (fMRI) will be used as a measure of hippocampus activation when remembering common objects and scenes. The study team will examine differences between participants with Opioid Use Disorder (OUD) and those without OUD.
Differences in Hippocampal (Hpc) volume
Time frame: Day 2 (MRI task visit)
T-1 weighted structural images for each participant will be used to compute the volume of the hippocampus in people with OUD compared to those without OUD.
Differences in hippocampal circuit connectivity
Time frame: Day 2 (MRI task visit)
Functional connectivity, measured with BOLD signal will be used to examine functional connectivity between the hippocampus, amygdala, and prefrontal cortex. The study team will examine differences in connectivity between participants with OUD and those without OUD.
Differences in performance
Time frame: Day 1 (computer tasks visit)
Number of correct responses will be used to assess memory for common objects and scenes. Differences in memory will be examined in between participants with OUD and those without OUD.
Differences in performance
Time frame: Day 2 (MRI task visit)
Number of correct responses will be used to assess memory for common objects and scenes. Differences in memory will be examined in between participants with OUD and those without OUD.
Differences in threat reactivity measured via skin conductance response (SCR)
Time frame: Day 1 (computer tasks visit)
Electrodermal activity collected with a bioamplifier will be used to quantify physiological reactivity to threat. Event related SCR will be measured as a baseline corrected response (peak minus baseline) to cues that predict threat compared to cues that do not predict threat. Differences in SCR between participants with OUD and participants without OUD will be examined.
Differences in threat reactivity measured via skin conductance response (SCR)
Time frame: Day 2 (MRI task visit)
Electrodermal activity collected with a bioamplifier will be used to quantify physiological reactivity to threat. Event related SCR will be measured as a baseline corrected response (peak minus baseline) to cues that predicted threat on the previous day compared to cues that did not predict threat. Differences in SCR between participants with OUD and participants without OUD will be examined.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 here (HUM00230585, HUM00121812) will not be eligible to complete the current study, due to possible learning/practice effects
- Unable to fit comfortably in the MRI scanner due to body size (typically men over 6 feet tall that weigh more than 250 lbs, men under 6 feet tall that weigh over 220 lbs, women over 5'11" tall that weigh more than 220 lbs, or women under 5'10" tall that weigh more than 200 lbs).
Where
- Ann Arbor, Michigan
Collaborators
National Institute on Drug Abuse (NIDA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 20, 2026 · Source of record for eligibility and locations