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NCT Number: NCT06355778

Adversity, Brain and Opioid Use Study

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.

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Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Healthy Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Aml Almamri

CONTACT

[email protected]

Elizabeth Duval, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 Tasks

Behavioral

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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aml Almamri

CONTACT

[email protected]

734-232-0190

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

A Mechanistic Investigation of Risk Factors for Opioid Use Disorder: Examining Hippocampal-based Context-dependent Learning and Memory Associated With Adverse Childhood Experiences

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 9, 2024
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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