Influence of Medication on Functional Connectivity
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Functional Connectivity Following Oxycodone Administration
研究概览
简要总结
This study will assess the effects of acute low-dose opioid administration on functional neuroimaging measures in healthy individuals
详细描述
This study will assess the effects of acute low-dose opioid administration on functional neuroimaging measures in healthy individuals (N=40, 20 male, 20 female). The objective of this research is to develop an understanding of factors that may influence individual variability on resting state functional connectivity in response to low-dose opioid administration with the longer term aim of understanding addictions vulnerability. Specifically, the proposed pilot research will explore the effects of single dose of oxycodone (15mg) on resting state functional connectivity and other common neuroimaging measures (e.g., diffusion MRI, structural MRI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •males or females, ages 18-30
- •for women of a child-bearing age, acceptable birth control methods or a negative pregnancy test prior to MRI scanning
- •ability to provide written, informed consent
- •eligibility and willingness to participate in fMRI scanning and to receive oxycodone
- •normal weight, as indicated by a body mass index (BMI) between 18.5 to 25
排除标准
- •current DSM-5 Axis I disorder
- •any psychotropic medication or medication known to interfere with metabolism of opioids
- •medical contraindication to participate in study activities (acute low-dose opioid admin) as determined by study physician
- •known family history (first-degree relative) of opioid-use disorder or alcohol-use disorder
- •not eligible for MRI scanning
- •positive drug screen
- •recent (past 6 months) medical or non-medical opioid-use
- •current or previous chronic pain disorder
- •significant lifetime use of prescription opioids (>7 days of consecutive medical use or nonmedical use on more than 5 occasions)
研究组 & 干预措施
Oxycodone Medication First
one hour before fMRI scan participants will be given a single dose 15mg immediate release oxycodone
干预措施: Oxycodone Medication First (Drug)
Placebo First
one hour before fMRI scan participants will be given a single dose placebo.
干预措施: Placebo First (Drug)
结局指标
主要结局
Change in Functional Connectivity Following Oxycodone Administration
时间窗: Change in functional connectivity from initial fMRI scan to follow-up MRI scan, up to 4 weeks.
Functional connectivity is measured by functional magnetic resonance imagery (fMRI). Change in functional connectivity (a statistical relationship between two regions in the brain) between placebo and oxycodone fMRI scans will be assessed. Result is a transformed z-score. A score of 0 indicates no change. Higher scores indicate increased connectivity.
次要结局
未报告次要终点