Understanding How Opioids Affect the Experiential and Neural Signatures of Social Experiences
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 217
- 试验地点
- 2
- 主要终点
- Daily feelings of social connection via ecological momentary assessment
研究概览
简要总结
The study is a randomized, placebo-controlled design with the opioid antagonist, oral naltrexone. Following random assignment, participants will take 50mg of naltrexone or placebo once a day for 7 days. On days 1 - 7, participants complete reports of their feelings of social connection and mood in order to assess more naturalistic feelings in response to opportunities for social connection outside of the laboratory setting. Additionally, at the end of each day, they complete a physical symptoms questionnaire. On the 7th day, participants will come to the SDSU MRI scanning facility to complete tasks designed to elicit feelings of social connection in the fMRI scanner. After the scan, feelings in response to the scanner tasks will be collected.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •good health
- •English fluency
- •willing to provide contact information for 4-6 close others
- •willing to provide digital photographs of 2 close others
- •own a smartphone
排除标准
- •presence of medical devices, implants, or other metal objects in or on the body that cannot be removed
- •tattooed eyeliner
- •a body habitus prohibiting MRI scanning
- •claustrophobia
- •self-reported chronic mental or physical illness
- •current and regular use of prescription medication
- •previous history of having difficulty taking pills
- •current use of opioid analgesics
- •depressive symptoms above a 9 on Patient Health Questionnaire
- •excessive alcohol use
- •positive urine drug test
- •body mass index (BMI) greater than 35
- •pregnancy or plans to become pregnant in next 6 months
- •positive urine pregnancy test
研究组 & 干预措施
placebo
sugar pill once daily for seven days by mouth
干预措施: Placebo (Drug)
Naltrexone
50mg naltrexone HCL once daily for seven days by mouth
干预措施: Naltrexone Hydrochloride (Drug)
结局指标
主要结局
Daily feelings of social connection via ecological momentary assessment
时间窗: post-treatment, change across 7 days
State feelings of social connection outside of the lab
Bold Oxygen-level Dependent (BOLD) Activations in Prespecified ROIs
时间窗: Day 7, approximately 60 mins after taking study drug
In the MRI scanner, participants read sentences written by people they know and people they do not know in a block design. In a second task they view images of people they know, those they do not know, and other emotional images. Brain activity will be measured as BOLD activity in response to stimuli from known (vs. unknown) people using functional magnetic resonance imaging (FMRI). Based on a priori hypotheses, brain activity will be masked to activity in structural regions-of- interest (ROIs) of the ventral striatum (VS), middle-insula (MI), anterior cingulate cortex (ACC) and ventromedial prefrontal cortex (VMPFC).
feelings in response to neuroimaging tasks
时间窗: Day 7, approximately 150 minutes after taking study drug
Feelings of social connection and general positive affect in response to the neuroimaging tasks will be reported on a scale of 1 (not at all) to 7 (very)
次要结局
- physical symptoms via daily diary(end of day on days 1-7)