Examining brain function and memory in relation to opioid use and childhood experiences
A Mechanistic Investigation of Risk Factors for Opioid Use Disorder: Examining Hippocampal-based Context-dependent Learning and Memory Associated With Adverse Childhood Experiences
NA · University of Michigan · NCT06355778
This study is trying to see how tough childhood experiences affect brain function and memory in adults with opioid use disorder compared to healthy adults.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 185 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | University of Michigan (other) |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT06355778 on ClinicalTrials.gov |
What this trial studies
This study investigates how adverse childhood experiences affect brain function and memory in adults with Opioid Use Disorder (OUD) compared to healthy individuals. Participants will undergo Magnetic Resonance Imaging (MRI) and perform computer tasks to assess their learning and memory capabilities. The study includes three groups: those with OUD on buprenorphine, those without OUD also on buprenorphine, and healthy adults not on buprenorphine. The goal is to understand the relationship between childhood adversity and opioid use through brain performance metrics.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with Opioid Use Disorder who are currently receiving buprenorphine treatment, as well as healthy adults without any substance use disorders.
Not a fit: Patients with significant medical or neurological conditions, or those actively suicidal, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment strategies for individuals with Opioid Use Disorder.
How similar studies have performed: Other studies have explored the relationship between childhood adversity and substance use, but this specific approach using MRI and memory tasks is relatively novel.
Eligibility criteria
Show full inclusion / 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 * 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).
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (RECRUITING)
Study contacts
- Principal investigator: Elizabeth Duval — University of Michigan
- Study coordinator: Aml Almamri
- Email: AdversityBrainOUD@med.umich.edu
- Phone: 734-232-4166
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Opioid Use Disorder, Healthy, Magnetic Resonance Imaging, Adverse Childhood Experiences, Fear Learning, Memory, Hippocampal function