Adversity, Brain and Opioid Use Study
A Mechanistic Investigation of Risk Factors for Opioid Use Disorder: Examining Hippocampal-based Context-dependent Learning and Memory Associated With Adverse Childhood Experiences
2 other identifiers
interventional
185
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2024
CompletedFirst Posted
Study publicly available on registry
April 9, 2024
CompletedStudy Start
First participant enrolled
January 9, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
December 12, 2025
December 1, 2025
3.2 years
April 4, 2024
December 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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.
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.
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.
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.
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.
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.
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.
Day 2 (MRI task visit)
Study Arms (3)
Opioid use disorder (OUD) group
OTHERThis group takes buprenorphine and has OUD.
Buprenorphine (BUP) control group:
OTHERThis group takes BUP and does not have OUD.
Healthy Controls group
OTHERThis group does not take BUP and does not have OUD.
Interventions
Eligible participants will complete computer tasks (cognitive tasks, spatial navigation tasks, context dependent fear learning, etc.) at visit 1 and then during the 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.
Eligibility Criteria
You may qualify if:
- Right handed
- 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
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth Duval
University of Michigan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Psychiatry
Study Record Dates
First Submitted
April 4, 2024
First Posted
April 9, 2024
Study Start
January 9, 2025
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
April 1, 2028
Last Updated
December 12, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- When the study is completed, access to study data will be provided by the PI as requested.
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.