| NCT ID | NCT06355778 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Michigan |
| Condition | Opioid Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 185 participants |
| Start Date | 2025-01-09 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 185 participants in total. It began in 2025-01-09 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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: * Fluent in English * 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: * Pregnancy * Significant medical or neurologic conditions (e.g., stroke, seizures, multiple sclerosis) * Actively suicidal * Contraindication for MRI * Inability to tolerate small, enclosed spaces without anxiety or unable to fit comfortably in the MRI scanner * Life history of schizophrenia, 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
Contact & Investigator
Elizabeth Duval
PRINCIPAL INVESTIGATOR
University of Michigan
Frequently Asked Questions
Who can join the NCT06355778 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Opioid Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06355778 currently recruiting?
Yes, NCT06355778 is actively recruiting participants. Contact the research team at AdversityBrainOUD@med.umich.edu for enrollment information.
Where is the NCT06355778 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT06355778 clinical trial?
NCT06355778 is sponsored by University of Michigan. The principal investigator is Elizabeth Duval at University of Michigan. The trial plans to enroll 185 participants.