Investigating the Neural Correlates of Driving After Medical Cannabis Exposure
试验速览
- 阶段
- 1 期
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in neural activation on fMRI during driving simulation
研究概览
简要总结
Driving is a set of complex tasks and requires use of multiple cognitive domains, including attention, planning, and memory. In laboratory studies, the main psychoactive component in cannabis, delta-9-tetrahydrocannabinol (THC), was shown to impair short-term memory, attention, reaction time, tracking, and coordination, resulting, for instance, in significantly more deviations from the lane and increased break latency. Surveys and epidemiological studies suggest that cannabis consumption is associated with increased risks of collision.
The current study aims to evaluate individual driving behavior and performance on various neurocognitive tests and their correlated neural networks while under the influence of cannabis and while sober. The investigators will use the STISIM driving simulator, which is fully MRI compatible, to study brain activation, while participants are performing various driving maneuvers.
The goals of the study are:
- identify driving performance and patterns in brain activation associated with cannabis exposure and compare them to brain patterns of the same participants while sober;
- compare participant's performance on cognitive tasks while under the influence of cannabis and sober;
- look for correlations between concentration of cannabinoids in the participants' blood and their driving performance and performance on cognitive tasks;
- correlate demographic variables and personal history (e.g. tolerance to drug) with performance and brain activation while driving under the influence of cannabis.
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
- None
入排标准
- 年龄范围
- 25 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •valid driver's license
- •have normal or corrected-to-normal vision
- •have had prior experience consuming cannabis
- •are currently not and have not been regular users in the past 5 years (regular use is defined as at least 1 time per week for at least 1 month)
- •prescribed medical cannabis
排除标准
- •not fluent in English
- •do not meet MRI screening criteria
- •use 50 mg/day of morphine equivalents
- •history of neurological, neurodegenerative or psychiatric diseases
- •any serious sensory or motor impairments
- •pregnant women or women trying to get pregnant, or breastfeeding
- •serious lung, liver, kidney, and heart problems, including angina, coronary artery disease, and arrhythmia, and Peripheral Vascular Disease
- •personal or family history of mental disorders or alcohol or drug abuse or dependence
研究组 & 干预措施
Cannabis - Jean Guy
A participant will be administered 1g of Jean Guy strain of cannabis.
干预措施: Cannabis (Drug)
Cannabis - Churchill
A participant will be administered 1g of Churchill strain of cannabis.
干预措施: Cannabis (Drug)
结局指标
主要结局
Change in neural activation on fMRI during driving simulation
时间窗: 30-60 min after cannabis intake vs sober
Neural activation, based on BOLD signal, while completing driving tasks under the influence of cannabis and sober.
次要结局
- Performance on driving simulator(30-60 min after cannabis intake vs sober)
- Performance on cognitive tasks(60-90 min after cannabis intake vs sober)
- Blood plasma concentration levels of cannabinoids(10 min and 60 min after cannabis intake)