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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06355778
Enrollment
185
Registered
2024-04-09
Start date
2025-01-09
Completion date
2028-04-01
Last updated
2026-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Opioid Use Disorder

Keywords

Magnetic Resonance Imaging (MRI), Adverse Childhood Experiences, Fear Learning, Memory, Hippocampal function

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.

Interventions

OTHERMagnetic 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.

BEHAVIORALComputer 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.

Sponsors

University of Michigan
Lead SponsorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

for all groups: * Fluent in English * 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: * 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 * 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

Design outcomes

Primary

MeasureTime frameDescription
Differences in Blood Oxygen Level Dependent (BOLD) signal in the hippocampusDay 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) volumeDay 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 connectivityDay 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 performanceDay 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 threat reactivity measured via skin conductance response (SCR)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.

Countries

United States

Contacts

CONTACTAml Almamri
AdversityBrainOUD@med.umich.edu734-232-0190
PRINCIPAL_INVESTIGATORElizabeth Duval

University of Michigan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 18, 2026