A Mechanistic Investigation of Risk Factors for Opioid Use Disorder: Examining Hippocampal-based Context-dependent Learning and Memory Associated With Adverse Childhood Experiences
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 185
- 试验地点
- 1
- 主要终点
- Differences in hippocampal circuit connectivity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Opioid use disorder (OUD) group
This group takes buprenorphine and has OUD.
干预措施: Computer Tasks (Behavioral)
Buprenorphine (BUP) control group:
This group takes BUP and does not have OUD.
干预措施: Magnetic Resonance Imaging (MRI) (Other)
Buprenorphine (BUP) control group:
This group takes BUP and does not have OUD.
干预措施: Computer Tasks (Behavioral)
Healthy Controls group
This group does not take BUP and does not have OUD.
干预措施: Magnetic Resonance Imaging (MRI) (Other)
Healthy Controls group
This group does not take BUP and does not have OUD.
干预措施: Computer Tasks (Behavioral)
Opioid use disorder (OUD) group
This group takes buprenorphine and has OUD.
干预措施: Magnetic Resonance Imaging (MRI) (Other)
结局指标
主要结局
Differences in hippocampal circuit connectivity
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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.
Differences in performance
时间窗: Day 1 (computer tasks 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.
Differences in threat reactivity measured via skin conductance response (SCR)
时间窗: Day 1 (computer tasks 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 predict threat compared to cues that do not predict threat. Differences in SCR between participants with OUD and participants without OUD will be examined.
次要结局
未报告次要终点
研究者
Elizabeth Duval
Associate Professor of Psychiatry
University of Michigan