Adversity, Brain and Opioid Use Study

Healthy Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06355778
• Other study ID #: HUM00234185
• Secondary ID: 1R01DA056415
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: April 2028

Study information

• Verified date: April 2024
• Source: University of Michigan
• Contact: Mariya Churina
• Phone: 734-232-0190
• Email: AdversityBrainOUD[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 315
• Est. completion date: April 2028
• Est. primary completion date: April 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in Blood Oxygen Level Dependent (BOLD) signal in the hippocampus	BOLD signal during functional magnetic resonance imaging (fMRI) will be used as a measure of hippocampus activation when remembering common objects and scenes. The study team will examine differences between participants with Opioid Use Disorder (OUD) and those without OUD.	Day 2 (MRI task visit)
Primary	Differences in Hippocampal (Hpc) volume	T-1 weighted structural images for each participant will be used to compute the volume of the hippocampus in people with OUD compared to those without OUD.	Day 2 (MRI task visit)
Primary	Differences in hippocampal circuit connectivity	Functional connectivity, measured with BOLD signal will be used to examine functional connectivity between the hippocampus, amygdala, and prefrontal cortex. The study team will examine differences in connectivity between participants with OUD and those without OUD.	Day 2 (MRI task visit)
Primary	Differences in performance	Number of correct responses will be used to assess memory for common objects and scenes. Differences in memory will be examined in between participants with OUD and those without OUD.	Day 1 (computer tasks visit)
Primary	Differences in performance	Number of correct responses will be used to assess memory for common objects and scenes. Differences in memory will be examined in between participants with OUD and those without OUD.	Day 2 (MRI task visit)
Primary	Differences in threat reactivity measured via skin conductance response (SCR)	Electrodermal activity collected with a bioamplifier will be used to quantify physiological reactivity to threat. Event related SCR will be measured as a baseline corrected response (peak minus baseline) to cues that predict threat compared to cues that do not predict threat. Differences in SCR between participants with OUD and participants without OUD will be examined.	Day 1 (computer tasks visit)
Primary	Differences in threat reactivity measured via skin conductance response (SCR)	Electrodermal activity collected with a bioamplifier will be used to quantify physiological reactivity to threat. Event related SCR will be measured as a baseline corrected response (peak minus baseline) to cues that predicted threat on the previous day compared to cues that did not predict threat. Differences in SCR between participants with OUD and participants without OUD will be examined.	Day 2 (MRI task visit)