Adversity, Brain and Opioid Use Study

NCT ID: NCT06355778

Last Updated: 2025-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-09

Study Completion Date

2028-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Opioid Use Disorder Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Opioid use disorder (OUD) group

This group takes buprenorphine and has OUD.

Group Type OTHER

Magnetic Resonance Imaging (MRI)

Intervention Type 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

Intervention Type 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.

Buprenorphine (BUP) control group:

This group takes BUP and does not have OUD.

Group Type OTHER

Magnetic Resonance Imaging (MRI)

Intervention Type 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

Intervention Type 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.

Healthy Controls group

This group does not take BUP and does not have OUD.

Group Type OTHER

Magnetic Resonance Imaging (MRI)

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth Duval

Associate Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elizabeth Duval

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Aml Almamri

Role: CONTACT

734-232-4166

Madeline Vincent

Role: CONTACT

734-232-0190

Facility Contacts

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Aml Almamri

Role: primary

Other Identifiers

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1R01DA056415

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00234185

Identifier Type: -

Identifier Source: org_study_id

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