Multimodal Magnetoencephalography and Electroencephalography Exploration of the Acute Effects of THC Exposure on Neural Noise and Information Transmission Within Working Memory Networks
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Changes in brain dynamics during the Sternberg Working Memory Task
研究概览
简要总结
The purpose of this study is to use non-invasive brain imaging methods (MEG and EEG) to characterize the effects of THC on brain activity during learning.
详细描述
The goal of this study is to use multimodal MEG/EEG to gain novel insight into the acute effects of THC on neural noise and its interaction with the fast information processing dynamics of the brain's cognition-related functional neural networks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cannabis use at least once in the past 12 months
- •No cannabis use during the course of the study confirmed with negative urine toxicology at screening and on each test day
- •Good physical and mental health
排除标准
- •Cannabis naïve individuals
- •Lifetime or current medical, psychiatric or psychosocial disorders or history that is deemed unsuitable for participation in the study per PI discretion.
- •Positive pregnancy test, lactation, or refusal to practice birth control for the duration of the study and for two weeks following completion
- •Major current or recent stressors
- •Positive urine drug test
- •Contraindication for Magnetic Resonance Imaging
- •Treatment with psychotropic medication as per discretion of the PI
- •IQ less than 80
- •Weight exceeding 166kg
- •Diagnosis of major psychotic or manic disorder in first-degree relatives.
研究组 & 干预措施
THC
Participants will receive THC into a rapidly flowing IV infusion.
干预措施: THC (Drug)
Placebo
Participants will receive an equivalent amount (about 1-2 ml) of placebo (sterile 190 proof USP ethanol). The placebo does not produce any measurable blood alcohol levels or subjective/behavioral effects.
干预措施: Placebo (Other)
结局指标
主要结局
Changes in brain dynamics during the Sternberg Working Memory Task
时间窗: Baseline and starting at +15 minutes after start of IV THC or placebo administration
Changes in brain dynamics will be characterized during the Sternberg Working Memory Task where participants are presented with a list of items to memorize, followed by a memory maintenance period during which the subject must maintain the list of items in memory.
次要结局
- Visual Analog Scale (VAS)(Baseline and starting at +15 minutes after start of IV THC or placebo administration)
- Clinician Administered Dissociative Symptoms Scale (CADSS)(Baseline and starting at +15 minutes after start of IV THC or placebo administration)
研究者
Jose Cortes
Assistant Professor of Psychiatry
Yale University