Opioid Use DisorderNCT06355778
Adversity, Brain and Opioid Use Study
A study testing Magnetic Resonance Imaging (MRI) and Computer Tasks in people with Opioid Use Disorder and Healthy, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Use Disorder, Healthy
- What is being tested?
- Magnetic Resonance Imaging (MRI) and Computer Tasks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2025to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Fluent in English
- Able to give informed consent
- Normal/corrected-to-normal vision and hearing
- Diagnosis of OUD
- Be actively receiving buprenorphine (BUP) for opioid agonist therapy
- Be free from illicit substance use for at least 2 weeks
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- The study will allow stable dose (> 3 months) of commonly prescribed psychiatric medications and some sleep aids (per protocol)
- 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)
- Not taking BUP
- Free of any psychiatric or major medical conditions
Who cannot join
- Pregnancy
- Significant medical or neurologic conditions (e.g., stroke, seizures, multiple sclerosis)
- Actively suicidal
- Contraindication for MRI
- Inability to tolerate small, enclosed spaces without anxiety or unable to fit comfortably in the MRI scanner
- Life history of schizophrenia, learning disability, attention deficit disorder, or pervasive developmental disorder
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Aml Almamri, AdversityBrainOUD@med.umich.edu
Elizabeth Duval, PhD
About this study
Official title: A Mechanistic Investigation of Risk Factors for Opioid Use Disorder: Examining Hippocampal-based Context-dependent Learning and Memory Associated With Adverse Childhood Experiences
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.
- Conditions
- Opioid Use Disorder, Healthy
- Being tested
- Magnetic Resonance Imaging (MRI), Computer Tasks
- Keywords
- Magnetic Resonance Imaging (MRI), Adverse Childhood Experiences, Fear Learning, Memory, Hippocampal function
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI)Other
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.
Computer TasksBehavioural
Eligible participants will complete computer tasks (cognitive tasks, spatial navigation tasks, context dependent fear learning, etc.) at visit 1 and then during the MRI.
| Study group | Role | What they receive |
|---|---|---|
| Opioid use disorder (OUD) group | Other | This group takes buprenorphine and has OUD. Receives: Other: Magnetic Resonance Imaging (MRI); Behavioral: Computer Tasks |
| Buprenorphine (BUP) control group: | Other | This group takes BUP and does not have OUD. Receives: Other: Magnetic Resonance Imaging (MRI); Behavioral: Computer Tasks |
| Healthy Controls group | Other | This group does not take BUP and does not have OUD. Receives: Other: Magnetic Resonance Imaging (MRI); Behavioral: Computer Tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in Blood Oxygen Level Dependent (BOLD) signal in the hippocampus
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.
Measured: Day 2 (MRI task visit)
Differences in Hippocampal (Hpc) volume
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.
Measured: Day 2 (MRI task visit)
Differences in hippocampal circuit connectivity
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.
Measured: Day 2 (MRI task visit)
Differences in performance
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.
Measured: Day 1 (computer tasks visit)
Differences in performance
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.
Measured: Day 2 (MRI task visit)
Differences in threat reactivity measured via skin conductance response (SCR)
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.
Measured: Day 1 (computer tasks visit)
Differences in threat reactivity measured via skin conductance response (SCR)
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.
Measured: Day 2 (MRI task visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start9 Jan 2025
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 185 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Elizabeth Duval, University of Michigan
- Investigators
- Elizabeth Duval, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355778
- Sponsor's protocol ID
- HUM00234185
- Other IDs
- 1R01DA056415
- Status last verified
- Dec 2025
- First submitted
- 4 Apr 2024
- Last updated
- 17 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It is NIH policy that the results and accomplishments of the activities that it funds should be made available to the public. The principal investigator (PI) will ensure all mechanisms used to share data will include proper plans and safeguards for the protection of privacy, confidentiality, and security for data dissemination and reuse (e.g., all data will be thoroughly de-identified and will not be traceable to a specific study participant). Plans for archiving and long-term preservation of the data will be implemented, as appropriate.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mechanistic Investigation of Risk Factors for Opioid Use Disorder: Examining Hippocampal-based Context-dependent Learning and Memory Associated With Adverse Childhood Experiences
- ClinicalTrials.gov ID
- NCT06355778
- Acronym / sponsor ID
- HUM00234185
- Conditions
- Opioid Use Disorder, Healthy
- Keywords
- Magnetic Resonance Imaging (MRI), Adverse Childhood Experiences, Fear Learning, Memory, Hippocampal function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 185 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 9 Jan 2025 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Opioid use disorder (OUD) group | Other | Other: Magnetic Resonance Imaging (MRI), Behavioral: Computer TasksThis group takes buprenorphine and has OUD. |
| Buprenorphine (BUP) control group: | Other | Other: Magnetic Resonance Imaging (MRI), Behavioral: Computer TasksThis group takes BUP and does not have OUD. |
| Healthy Controls group | Other | Other: Magnetic Resonance Imaging (MRI), Behavioral: Computer TasksThis group does not take BUP and does not have OUD. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Fluent in English
- Able to give informed consent
- Normal/corrected-to-normal vision and hearing
- Diagnosis of OUD
- Be actively receiving buprenorphine (BUP) for opioid agonist therapy
Key exclusion criteria (9 listed)
- Pregnancy
- Significant medical or neurologic conditions (e.g., stroke, seizures, multiple sclerosis)
- Actively suicidal
- Contraindication for MRI
- Inability to tolerate small, enclosed spaces without anxiety or unable to fit comfortably in the MRI scanner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Buprenorphine (BUP) control group:, Healthy Controls group, Opioid use disorder (OUD) group |
| Computer TasksEligible participants will complete computer tasks (cognitive tasks, spatial navigation tasks, context dependent fear learning, etc.) at visit 1 and then during the MRI. | Behavioural | Buprenorphine (BUP) control group:, Healthy Controls group, Opioid use disorder (OUD) group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: Yes. It is NIH policy that the results and accomplishments of the activities that it funds should be made available to the public. The principal investigator (PI) will ensure all mechanisms used to share data will include proper plans and safeguards for the protection of privacy, confidentiality, and security for data dissemination and reuse (e.g., all data will be thoroughly de-identified and will not be traceable to a specific study participant). Plans for archiving and long-term preservation of the data will be implemented, as appropriate.
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Substance Use Disorders (SUDs)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth Duval principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging (MRI) and Computer Tasks in people with Opioid Use Disorder and Healthy, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aml Almamri (734-232-0190, AdversityBrainOUD@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in Blood Oxygen Level Dependent (BOLD) signal in the hippocampus (time frame: Day 2 (MRI task visit)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.