The Effects of Cannabidiol on the Driving Ability of Healthy Adults: a Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Driving Performance - Percent of Time Spent Out of Lane
研究概览
简要总结
A randomized, parallel-group, double-blind, exploratory two-arm trial to assess the effects of CBD on driving ability along with changes in psychological status (i.e. mood, drowsiness, sedation) and cognitive function. Forty healthy West Virginia University (WVU) students will be allocated and randomized to receive: (1) 300 mg of pure CBD oil or (N=20) (2) placebo matched in appearance and taste (N=20). After consuming the study drug, each individual will participate in a 25-35-minute driving simulation and their driving performance measured. To assess changes in psychological status (i.e. mood, drowsiness, sedation) and drug impairment-related cognitive function, the Visual Analog Mood Scale, Stanford Sleepiness Scale , Digital Symbol Substitution Test, Trail Making Test Part A and B, Psychomotor Vigilance Test, and Simple Reaction Time test will also be administered to participants at baseline (prior to study drug consumption) and following completion of the driving simulation test. The entire protocol will be completed in one day and should take 4-4.5 hours to complete for each participant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •the participant must be currently enrolled as a WVU student, 2) be 18-30 years of age at time of study, 3) have a current drivers' license issued from any state in the United States, 4) has driven at least once in the past 30 days 5) is able to speak and read English, 6) is willing to be randomized and comply with study requirements including a urine drug test on the day they consent to participate in the experiment and complete a test drive to ensure the absence of simulation sickness, 7) not currently taking any daily prescription medications other than birth control, 8) have not been diagnosed with any serious chronic disease by a licensed healthcare provider (including but not limited to Alzheimer's and related dementias, Parkinson's disease or other neurodegenerative disorder, major depressive or anxiety disorder, schizophrenia or other serious mental illness, arrhythmias, cataracts, glaucoma, chronic obstructive pulmonary disease, diabetes, epilepsy, sleep apnea, and fibromyalgia), and 9) has an individual able to drive them home after testing or is willing to be driven home by study staff after testing completion.
排除标准
- •Participants will be excluded if they 1) currently smoke or use tobacco products, 2) have used illegal drugs (including cocaine/crack, heroin, methamphetamine, 3,4-methylenedioxy-methamphetamine, inhalants, phencyclidine, lysergic acid, mushrooms, or marijuana) in the past 30 days, 3) has consumed CBD in the past 7 days, or 4) is currently pregnant or lactating
研究组 & 干预措施
300 mg Cannabidiol (CBD) oil
干预措施: 300 mg Cannabidiol (CBD) oil (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Driving Performance - Percent of Time Spent Out of Lane
时间窗: 1.5 hour post intervention
From driving simulation. A greater percentage of time spent driving out of lane indicates worse performance. Min=0 max=100%
Driving Performance - Number of Collisions.
时间窗: 1.5 hour post intervention
From driving simulation. A greater number of collisions indicate worse performance. Min=0 max=infinity
Driving Performance - Brake Reaction Time
时间窗: 1.5 hour post intervention
Mean reaction time to stimuli from driving simulation. Longer reaction times indicate worst performance. Min=0 max=infinity
Driving Performance - Lateral Position in Lane
时间窗: 1.5 hour post intervention
Mean standard deviation of lateral position in lane under consistent speed from driving simulation. Larger standard deviations in lane position indicate worse performance. Min=0 max=infinity
Driving Performance-percent of Time Spent Driving Above Speed Limit
时间窗: 1.5 hour post intervention
From driving simulation. This is the percent of drive time that the driver spent driving above the speed limit. Greater percentage indicates worse performance.
次要结局
- Change in Baseline VAMS for Mental Sedation(4 hours after baseline)
- Change in Baseline VAMS--Physical Sedation(4 hours after baseline)
- Change in Baseline SSS(4 hours after baseline)
- Change in Baseline DSST(4 hours after baseline)
- Change in Baseline TMT Part A(4 hours after baseline)
- Change in Baseline TMT Part B(4 hours after baseline)
- Change in Baseline PVT(4 hours after baseline)
- Change in Baseline SRT for Sound #1(4 hours after baseline)
- Change in Baseline SRT--sound #2(4 hours after baseline)
研究者
Toni Marie Rudisill
Research Assistant Professor
West Virginia University