Adversity, Brain and Opioid Use Study

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University of Michigan

Status

Not yet enrolling

Conditions

Healthy
Opioid Use Disorder

Treatments

Behavioral: Computer Tasks
Other: Magnetic Resonance Imaging (MRI)

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06355778
HUM00234185
1R01DA056415 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

315 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for all groups:

  • Right handed
  • 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
  • Never had a 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:

  • Significant medical or neurologic conditions (e.g., stroke, seizures, multiple sclerosis)
  • Actively suicidal
  • Contraindication for MRI
  • Life history of schizophrenia, bipolar disorder, learning disability, attention deficit disorder, or pervasive developmental disorder
  • Illicit substance use (past 2 weeks)
  • Prescription medications that could interfere with measures of interest (per protocol)
  • Unable to provide informed consent.

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

315 participants in 3 patient groups

Opioid use disorder (OUD) group
Other group
Description:
This group takes buprenorphine and has OUD.
Treatment:
Other: Magnetic Resonance Imaging (MRI)
Behavioral: Computer Tasks
Buprenorphine (BUP) control group:
Other group
Description:
This group takes BUP and does not have OUD.
Treatment:
Other: Magnetic Resonance Imaging (MRI)
Behavioral: Computer Tasks
Healthy Controls group
Other group
Description:
This group does not take BUP and does not have OUD.
Treatment:
Other: Magnetic Resonance Imaging (MRI)
Behavioral: Computer Tasks

Trial contacts and locations

1

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Central trial contact

Mariya Churina

Data sourced from clinicaltrials.gov

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