Recruiting

OUD with Buprenorphine

Sponsor:

University of Michigan

Code:

NCT06355778

Conditions

Opioid Use Disorder

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Magnetic Resonance Imaging (MRI)

Computer Tasks

Study Details

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.

Conditions

Opioid Use Disorder

Healthy

Study ID

NCT06355778

Start date

Jan 9, 2025

Status verified date

Dec, 2025

Completion date

Apr, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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

Study Design

Enrollment

185 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: Opioid use disorder (OUD) group

This group takes buprenorphine and has OUD.

other: Buprenorphine (BUP) control group:

This group takes BUP and does not have OUD.

other: Healthy Controls group

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

Interventions

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.

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 measure

  • 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) ]

Central Contacts and Locations

Central contacts

Aml Almamri

734-232-0190AdversityBrainOUD@med.umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Aml Almamri

AdversityBrainOUD@med.umich.edu

Principal Investigator:

Elizabeth Duval, PhD

More Information

Sponsor

University of Michigan

Last update posted

Jul 17, 2026

Last verified

Dec, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-07-17.