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临床试验/NCT04925076
NCT04925076已完成不适用

Characterizing the Effects of Family History of Alcoholism on Alcohol Analgesia

University of Florida1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2018年11月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
125
试验地点
1
主要终点
Heat Pain Threshold

研究概览

简要总结

Self-medication of pain with alcohol is a common, yet risky, behavior. Evidence suggests family history of alcoholism may affect the degree to which alcohol use relieves pain, but the independent contributions of expectation and conditioning have not been previously studied. Interactive effects of sex and family history are also currently unclear. This project addresses this gap in knowledge and will inform further research and clinical/translational efforts for reducing risk associated with these behaviors.

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
Double (Participant, Investigator)

入排标准

年龄范围
21 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Consume at least 1 drink/month over the past 6 months

排除标准

  • History of chronic pain
  • Current use of opioids
  • Current major depression
  • History of any psychotic disorder
  • Undercontrolled hypertension or diabetes
  • History of neurologic disease
  • History of serious medical illness
  • History of drug or alcohol dependence, including nicotine, or a pattern of hazardous alcohol use
  • Safety concerns related to MRI (for example, implants or pacing devices)

研究组 & 干预措施

Family History Positive

Experimental

People reporting at least one parent with a history of alcohol problems.

干预措施: Ethanol (Drug)

Family History Positive

Experimental

People reporting at least one parent with a history of alcohol problems.

干预措施: Placebo (Other)

Family History Negative

Experimental

People who do not report having a parent with a history of alcohol problems.

干预措施: Ethanol (Drug)

Family History Negative

Experimental

People who do not report having a parent with a history of alcohol problems.

干预措施: Placebo (Other)

结局指标

主要结局

Heat Pain Threshold

时间窗: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)

Temperature of heat stimulus applied to the foot at which participant reports pain. VAS (visual analogue scale) pain intensity and unpleasantness ratings anchored from "no pain at all"/"not at all unpleasant" to "most intense/unpleasant imaginable" will be collected.

Heat Pain Tolerance

时间窗: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)

Temperature of heat stimulus applied to the foot at which participant no longer tolerates pain. VAS (visual analogue scale) pain intensity and unpleasantness ratings anchored from "no pain at all"/"not at all unpleasant" to "most intense/unpleasant imaginable" will be collected.

Heat Pain Intensity Ratings

时间窗: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)

Participant perception of pain at a temperature producing a pain rating of approximately 5 out of 10 at baseline. VAS (visual analogue scale) pain intensity ratings ranging from 0-100 and anchored from "no pain at all" to "most intense imaginable" will be collected. Higher values reflect ratings of more intense pain.

Perceived Pain Relief

时间窗: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)

Rating of relief from pain associated with consumption of the study beverage. This is a VAS (visual analogue scale) assessing perceived pain relief ranging from 0-100 and anchored from "No relief at all" to "Most profound relief imaginable". Higher scores reflect greater perception of pain relief.

Dorsolateral Prefrontal Cortex Activation

时间窗: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)

Pain-related activation in the dorsolateral prefrontal cortex associated with application of painful heat vs. non-noxious warmth to the bottom of the right foot during fMRI acquisition. Scores are beta-weights associated with fit of activity within the region to activity predicted by convolving the canonical hemodynamic response function with the heat pain stimulus paradigm assessed using general linear modeling. Positive beta weights reflect activation associated with the stimulus paradigm, while negative beta weights reflect deactivation.

Hypothalamus Activation

时间窗: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours

Pain-related activation in the hypothalamus associated with application of painful heat vs. non-noxious warmth to the bottom of the right foot during fMRI acquisition. Scores are beta-weights associated with fit of activity within the region to activity predicted by convolving the canonical hemodynamic response function with the heat pain stimulus paradigm assessed using general linear modeling. Positive beta weights reflect activation associated with the stimulus paradigm, while negative beta weights reflect deactivation.

Medial Prefrontal Cortex Activation

时间窗: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)

Pain-related activation in the medial prefrontal cortex associated with application of painful heat vs. non-noxious warmth to the bottom of the right foot during fMRI acquisition. Scores are beta-weights associated with fit of activity within the region to activity predicted by convolving the canonical hemodynamic response function with the heat pain stimulus paradigm assessed using general linear modeling. Positive beta weights reflect activation associated with the stimulus paradigm, while negative beta weights reflect deactivation.

Nucleus Accumbens Activation

时间窗: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)

Pain-related activation in the nucleus accumbens associated with application of painful heat vs. non-noxious warmth to the bottom of the right foot during fMRI acquisition. Scores are beta-weights associated with fit of activity within the region to activity predicted by convolving the canonical hemodynamic response function with the heat pain stimulus paradigm assessed using general linear modeling. Positive beta weights reflect activation associated with the stimulus paradigm, while negative beta weights reflect deactivation.

Periaqueductal Gray Activation

时间窗: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)

Pain-related activation in the periaqueductal gray associated with application of painful heat vs. non-noxious warmth to the bottom of the right foot during fMRI acquisition. Scores are beta-weights associated with fit of activity within the region to activity predicted by convolving the canonical hemodynamic response function with the heat pain stimulus paradigm assessed using general linear modeling. Positive beta weights reflect activation associated with the stimulus paradigm, while negative beta weights reflect deactivation.

Anterior Cingulate Cortex Activation

时间窗: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)

Pain-related activation in the anterior cingulate cortex associated with application of painful heat vs. non-noxious warmth to the bottom of the right foot during fMRI acquisition. Scores are beta-weights associated with fit of activity within the region to activity predicted by convolving the canonical hemodynamic response function with the heat pain stimulus paradigm assessed using general linear modeling. Positive beta weights reflect activation associated with the stimulus paradigm, while negative beta weights reflect deactivation.

Amgydala Activation

时间窗: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)

Pain-related activation in the amygdala associated with application of painful heat vs. non-noxious warmth to the bottom of the right foot during fMRI acquisition. Scores are beta-weights associated with fit of activity within the region to activity predicted by convolving the canonical hemodynamic response function with the heat pain stimulus paradigm assessed using general linear modeling. Positive beta weights reflect activation associated with the stimulus paradigm, while negative beta weights reflect deactivation.

Hippocampus Activation

时间窗: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)

Pain-related activation in the hippocampus associated with application of painful heat vs. non-noxious warmth to the bottom of the right foot during fMRI acquisition. Scores are beta-weights associated with fit of activity within the region to activity predicted by convolving the canonical hemodynamic response function with the heat pain stimulus paradigm assessed using general linear modeling. Positive beta weights reflect activation associated with the stimulus paradigm, while negative beta weights reflect deactivation.

Insula Activation

时间窗: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)

Pain-related activation in the insula associated with application of painful heat vs. non-noxious warmth to the bottom of the right foot during fMRI acquisition. Scores are beta-weights associated with fit of activity within the region to activity predicted by convolving the canonical hemodynamic response function with the heat pain stimulus paradigm assessed using general linear modeling. Positive beta weights reflect activation associated with the stimulus paradigm, while negative beta weights reflect deactivation.

Postcentral Gyrus Activation

时间窗: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)

Pain-related activation in the postcentral gyrus associated with application of painful heat vs. non-noxious warmth to the bottom of the right foot during fMRI acquisition. Scores are beta-weights associated with fit of activity within the region to activity predicted by convolving the canonical hemodynamic response function with the heat pain stimulus paradigm assessed using general linear modeling. Positive beta weights reflect activation associated with the stimulus paradigm, while negative beta weights reflect deactivation.

Thalamus Activation

时间窗: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)

Pain-related activation in the thalamus associated with application of painful heat vs. non-noxious warmth to the bottom of the right foot during fMRI acquisition. Scores are beta-weights associated with fit of activity within the region to activity predicted by convolving the canonical hemodynamic response function with the heat pain stimulus paradigm assessed using general linear modeling. Positive beta weights reflect activation associated with the stimulus paradigm, while negative beta weights reflect deactivation.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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