Gamma-Amino Butyric Acid (GABA) Deficits and Vulnerability to Cannabinoid-Induced Psychosis
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
- 是
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
- 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
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
Deepak C. D'Souza
Associate Professor of Psychiatry
Yale University
