Adversity, Brain and Opioid Use Study

Not Applicable

Recruiting

• Conditions: Opioid Use Disorder; Healthy
• Interventions: Other: Magnetic Resonance Imaging (MRI); Behavioral: Computer Tasks

• Registration Number: NCT06355778
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-04
• Study First Submitted QC: 2024-04-04
• Study First Posted: 2024-04-09
• Status Verified: 2025-01
• Study Start: 2025-01-09
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-13
• Primary Completion: 2028-04
• Study Completion: 2028-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 315

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Differences in hippocampal circuit connectivity	Day 2 (MRI task visit)	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.
Differences in Blood Oxygen Level Dependent (BOLD) signal in the hippocampus	Day 2 (MRI task visit)	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.
Differences in Hippocampal (Hpc) volume	Day 2 (MRI task visit)	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.
Differences in threat reactivity measured via skin conductance response (SCR)	Day 2 (MRI task visit)	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.
Differences in performance	Day 2 (MRI task visit)	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.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States