Adversity, Brain and Opioid Use Study

Официальное название

A Mechanistic Investigation of Risk Factors for Opioid Use Disorder: Examining Hippocampal-based Context-dependent Learning and Memory Associated With Adverse Childhood Experiences

Обзор

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.

Вмешательства

• Другое 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.
• Поведенческое 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.

Первичные конечные точки

• Differences in Blood Oxygen Level Dependent (BOLD) signal in the hippocampus [Срок оценки: Day 2 (MRI task visit)]
• Differences in Hippocampal (Hpc) volume [Срок оценки: Day 2 (MRI task visit)]
• Differences in hippocampal circuit connectivity [Срок оценки: Day 2 (MRI task visit)]
• Differences in performance [Срок оценки: Day 1 (computer tasks visit)]
• Differences in performance [Срок оценки: Day 2 (MRI task visit)]
• Differences in threat reactivity measured via skin conductance response (SCR) [Срок оценки: Day 1 (computer tasks visit)]
• Differences in threat reactivity measured via skin conductance response (SCR) [Срок оценки: Day 2 (MRI task visit)]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• University of Michigan — Ann Arbor

Идентификаторы

NCT: NCT06355778 · HUM00234185 · 1R01DA056415

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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