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Recruiting NCT06355778

Adversity, Brain and Opioid Use Study

No phase Interventional Opioid Use Disorder Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Magnetic Resonance Imaging (MRI), Computer Tasks.
Who it may be relevant to
Registry conditions: Opioid Use Disorder, Healthy. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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)]
  • Differences in Hippocampal (Hpc) volume [Time frame: Day 2 (MRI task visit)]
  • Differences in hippocampal circuit connectivity [Time frame: Day 2 (MRI task visit)]
  • Differences in performance [Time frame: Day 1 (computer tasks visit)]
  • Differences in performance [Time frame: Day 2 (MRI task visit)]
  • Differences in threat reactivity measured via skin conductance response (SCR) [Time frame: Day 1 (computer tasks visit)]
  • Differences in threat reactivity measured via skin conductance response (SCR) [Time frame: Day 2 (MRI task visit)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • University of Michigan — Ann Arbor

Identifiers

NCT: NCT06355778 · HUM00234185 · 1R01DA056415

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗