An fMRI Study of Opioid-related Changes in Neural Activity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Bold Oxygen-level Dependent (BOLD) Activations in Prespecified ROIs
研究概览
简要总结
The purpose of the study is to explore the effect of blocking opioids on affiliation-related neural activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •good health
- •between the ages of 18 and 35,
- •fluent in English
- •right-handed (for the fMRI scan)
排除标准
- •Self-reported current or past diagnoses of physical or mental illness.
- •Score on the Patient Health Questionnaire (depressive symptoms) above a 13
- •Positive urine drug test (for Tetrahydrocannabinol (THC), Opiates, Cocaine, Amphetamine (AMP), and Methamphetamine (mAMP))
- •Positive urine pregnancy test
- •Use of any prescription medication, except for birth control
- •Use of any over-the-counter medications on the day of the fMRI session and 24 hours after the fMRI session
- •Self-reported problems with liver functioning, including hepatitis or liver failure
- •Difficulty swallowing or taking pills
- •BMI greater than 35 or weight greater than 400 lbs
- •Claustrophobia
- •Nonremovable metal in the body
研究组 & 干预措施
sugar pill
single sugar pill
干预措施: Placebo (Drug)
naltrexone
single 50mg dose of naltrexone
干预措施: Naltrexone (Drug)
结局指标
主要结局
Bold Oxygen-level Dependent (BOLD) Activations in Prespecified ROIs
时间窗: approximately one hour after taking study drug
In the MRI scanner, participants read sentences written by people they knew and people they did not know in a block design. Brain activity was measured as BOLD activity in response to reading sentences from known (vs. unknown) people using functional magnetic resonance imaging (FMRI). Based on a priori hypotheses, brain activity was masked to activity in structural regions-of-interest (ROIs) of the ventral striatum (VS) and middle-insula (MI).
Self-reported Feelings of Connection in Response to the Scanner Tasks
时间窗: approximately two hours after taking study drug
feelings of social connection in response to reading sentences from known people (i.e. average of how connected, touched, warm did you feel). Feelings were reported on a scale of 1 (not at all) to 7 (very) such that higher numbers reflect greater feelings of social connection. time frame was mistakenly entered as the start of the fMRI scan, but participants reported on their feelings of social connection after the scan. Thus, the outcome measure time frame is reported as two, rather than one, hour after taking the study drug.
次要结局
未报告次要终点
研究者
Tristen Inagaki
Assistant Professor
University of Pittsburgh