Adversity, Brain and Opioid Use Study

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
• Inability to tolerate small, enclosed spaces without anxiety
• 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
• 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).

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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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