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临床试验/NCT00982982
NCT00982982已完成早期 1 期

Gamma-Amino Butyric Acid (GABA) Deficits and Vulnerability to Cannabinoid-Induced Psychosis

Yale University1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2009年2月11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
17
试验地点
1
主要终点
Clinician Administered Dissociative Symptoms Scale

研究概览

简要总结

The study aims to examine the combined effects of delta-9-tetrahydrocannabinol (∆-9-THC or THC) and iomazenil on thinking, perception, mood, memory, attention, and electrical activity of the brain (EEG). THC is the active ingredient of marijuana, cannabis, "ganja", or "pot". Iomazenil is a drug that works opposite to drugs like valium. The purpose of this study is to determine whether the administration of iomazenil will alter the effects of THC.

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
Male
接受健康志愿者

入选标准

  • Exposed to cannabis at least once in their lifetime

排除标准

  • Cannabis naïve
  • History of hearing deficit

研究组 & 干预措施

THC and Iomazenil

Active Comparator
  • Iomazenil: 3.7 μg/kg intravenously over 10 minutes
  • Delta-9-THC (0.015 mg/kg = 1.05 mg in a 70kg individual), dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4th of a marijuana cigarette, or "joint". It is administered intravenously for 10 minutes

干预措施: THC and Iomazenil (Drug)

Placebo

Placebo Comparator

Control: small amount of alcohol intravenous (quarter teaspoon), with no THC

干预措施: Placebo (control) (Drug)

结局指标

主要结局

Clinician Administered Dissociative Symptoms Scale

时间窗: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min

Visual Analog Scale

时间窗: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min

Perceptual Aberration Scale

时间窗: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min

Positive and Negative Symptom Scale

时间窗: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min

Auditory Verbal Learning Test

时间窗: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min

次要结局

未报告次要终点

研究者

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

Deepak C. D'Souza

Associate Professor of Psychiatry

Yale University

研究点 (1)

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