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临床试验/NCT02407808
NCT02407808进行中(未招募)1 期

Cannabinoids, Learning, and Memory

Yale University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2015年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
80
试验地点
1
主要终点
Rey Auditory Verbal Learning Test (RAVLT)

研究概览

简要总结

The overarching goal of this study is to characterize the effects of cannabinoids on working and episodic memory.

详细描述

This study will be achieved by studying the acute effects of delta-9-tetrahydrocannabinol (THC), the main psychoactive component of cannabis and a cannabinoid-1 receptor (CB1R) agonist, on a wide range of memory tasks in healthy human subjects.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women aged 18 and 55 years (extremes included) on day of first dosing
  • Exposed to cannabis at least once in their lifetime

排除标准

  • Cannabis naive
  • Positive pregnancy screen during screening
  • Hearing deficits

研究组 & 干预措施

Placebo

Placebo Comparator

Control: small amount of alcohol intravenously (quarter teaspoon), with no THC over 20 minutes.

干预措施: Placebo (Drug)

THC

Active Comparator

Active THC (0.0015mg/kg-0.03mg/kg) administered over 20 minutes.

干预措施: THC (Drug)

THC

Active Comparator

Active THC (0.0015mg/kg-0.03mg/kg) administered over 20 minutes.

干预措施: Placebo (Drug)

Placebo

Placebo Comparator

Control: small amount of alcohol intravenously (quarter teaspoon), with no THC over 20 minutes.

干预措施: THC (Drug)

结局指标

主要结局

Rey Auditory Verbal Learning Test (RAVLT)

时间窗: +35 minutes after infusion

a measure of verbal episodic memory

N-Back Task

时间窗: +65 minutes after infusion

a measure of working memory

次要结局

  • Clinician Administered Dissociative Symptoms Scale (Total Score)(Baseline, +10, +85, and +240 minutes after the first infusion)
  • Visual Analog Scale (Total Score)(Baseline, +10, +85, +240 minutes after the first infusion)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohini Ranganathan

Associate Professor

Yale University

研究点 (1)

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