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临床试验/NCT04896489
NCT04896489已完成早期 1 期

Neuroimaging Mechanisms by Which Memory and Glucocorticoids Promote Risky Drinking

Yale University1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2021年5月12日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
27
试验地点
1
主要终点
Changes fMRI signal

研究概览

简要总结

The purpose of this study is to determine whether hydrocortisone biases formation of alcohol-related memories to potentiate drinking.

详细描述

This study aims to 1) Characterize the effect of elevated glucocorticoids during encoding on long-term memory for alcohol-related information; 2) Identify the neural mechanisms by which glucocorticoids influence encoding of alcohol-related experiences; and 3) Determine how glucocorticoid modulation of alcohol-related encoding relates to drinking after retrieving alcohol-related memories.

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, Investigator, Outcomes Assessor)

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

  • Able to read and write English
  • BMI 18-35
  • Beer drinking

排除标准

  • Meet current criteria for any substance use disorder, excluding caffeine
  • Current significant medical conditions or psychiatric symptoms requiring medication
  • Current use of medications/drugs that interfere with the HPA axis response
  • Peri and post-menopausal women, pregnant or lactating women, and those with hysterectomies
  • Metal in body (for MRI safety)
  • Systemic fungal infections (contraindication for hydrocortisone)
  • Known hypersensitivity to components of hydrocortisone tablets (hydrocortisone, calcium stearate, corn starch, lactose, mineral oil, sorbic acid, sucrose)

研究组 & 干预措施

hydrocortisone

Experimental

Participants receive hydrocortisone (20mg)

干预措施: Hydrocortisone 20 MG (Drug)

placebo

Placebo Comparator

Participants receive placebo.

干预措施: Placebo (Other)

结局指标

主要结局

Changes fMRI signal

时间窗: 1 hour

Changes in fMRI signal at encoding will be assessed over an hour long period.

Item memory

时间窗: Up to 90 minutes

Item memory will be assessed through performance on delayed memory assessments. Item memory is determined by the accuracy of memory for individual items and will be expressed as dprime.

Context memory

时间窗: Up to 90 minutes

Context memory will be assessed through performance on delayed memory assessments. Context memory is determined by the accuracy of memory for associated contexts and will be expressed as % correct.

Affect memory

时间窗: Up to 90 minutes

Affect memory will be assessed through performance on delayed memory assessments. Affect memory is determined by subjective ratings of vividness (1-4), change in ratings from encoding to retrieval of memory (0-3). The score is averaged where a higher score indicates greater affect.

次要结局

  • Alcohol motivation(10 minutes)
  • Affect - Negative(10 minutes)
  • Affect - Positive(10 minutes)
  • Neuroendocrine/cortisol reactivity(Baseline to 2 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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