Clinical trial NCT06355778: Adversity, Brain and Opioid Use Study
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Healthy
Keywords: Magnetic Resonance Imaging (MRI)
Adverse Childhood Experiences
Fear Learning
Memory
Hippocampal function
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-04-09
Enrollment: 315
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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
* 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:

* 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
* 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
* 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).

Primary outcomes:
measure: Differences in Blood Oxygen Level Dependent (BOLD) signal in the hippocampus
timeFrame: Day 2 (MRI task visit)
measure: Differences in Hippocampal (Hpc) volume
timeFrame: Day 2 (MRI task visit)
measure: Differences in hippocampal circuit connectivity
timeFrame: Day 2 (MRI task visit)
measure: Differences in performance
timeFrame: Day 1 (computer tasks visit)
measure: Differences in performance
timeFrame: Day 2 (MRI task visit)
measure: Differences in threat reactivity measured via skin conductance response (SCR)
timeFrame: Day 1 (computer tasks visit)
measure: Differences in threat reactivity measured via skin conductance response (SCR)
timeFrame: Day 2 (MRI task visit)
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Elizabeth Duval
role: PRINCIPAL_INVESTIGATOR
References: