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临床试验/NCT03964350
NCT03964350已完成早期 1 期

Behavior and Brain Responses to Drugs

University of Chicago1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年5月28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
30
试验地点
1
主要终点
Change in Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire Across Sessions

研究概览

简要总结

To compare responses to acute oral doses of ethanol in healthy young adults who experience mainly stimulant subjective effects from the drug or mainly sedative effects.

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 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Ethanol

Experimental

Subjects will receive ethanol (0.4 or 0.8 g/kg) which will be administered in a gelatin vehicle.

干预措施: Ethanol (Drug)

Placebo (gelatin vehicle)

Placebo Comparator

Subjects will receive placebo of black cherry sugar-free jello.

干预措施: Placebo (Other)

结局指标

主要结局

Change in Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire Across Sessions

时间窗: At expected peak drug effect (30 min post drink administration)

Participants will complete The Drug Effects Questionnaire during the initial baseline session to determine their subjective alcohol profile. The Drug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states : "Feel Drug", "Feel High", "Like Drug", and "Want More". All sub-scales ("Feel Drug", "Feel High", "Like Drug", and "Want More") are scored on a visual analogue scale (scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome.

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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