Examine the Feasibility of a Standardized Field Test for Marijuana Impairment: Laboratory Evaluations
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Marijuana induced performance changes on Cogstate 1-back/2-back task.
研究概览
简要总结
Marijuana is one of the most widely used substances. This study will characterize the persistence of cannabis' (CNB's) acute effects on cognitive test performance and simulated driving over a several hour time period. The data obtained from simulated driving, cognitive tests, and biological assays of THC will be used in analyses aimed at identifying what tests or combination of tests predict both recent use and driving impairment risk.
Eligible participants will undergo a full day screening visit, if still eligible they will come to Hartford Hospital in Hartford, Connecticut to take part in the full study. Participation requires overnight stays between each of the five study visits. On each of the study days participants are dosed with either a low dose of THC marijuana, a high dose of THC marijuana or placebo marijuana, (the low and high doses are repeated once each, order in which the study drug is given is double blind and chosen at random.)
详细描述
This responds to NHTSA's request with a proposal to increase our understanding of smoked cannabis' (CNB's) acute effects on cognition and simulated driving performance, the persistence of these deficits over the hours after use, and the influence of prior experience with CNB on these effects. The project also will link an extensive literature on CNB's effects on laboratory cognitive tests to simulated driving performance for the first time, providing a crucial validation of CNB's neurofunctional effects identifying maximally relevant candidate measures for field sobriety tests. To this goal, the proposed study was based upon a careful and thorough review of the scientific literature describing CNB effects on cognitive test performance and driving, as well as current state-of-knowledge on the sensitivity of biological assays for identifying recent CNB use. The study will carefully characterize the persistence of CNB's acute effects on cognitive test performance and driving over a several-hour time span. This will allow us to identify the point at which any effects of CNB intoxication on cognitive tests and driving performance cannot be distinguished from normal, i.e., the first step towards establishing standards for legal and social policy. The data obtained from simulated driving, cognitive tests, and biological assays of THC will be used in analyses aimed at identifying what tests or combination of tests predict both recent use and driving impairment risk.
Participants
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must have a current driver's license
- •Have used marijuana before
- •Right handed
排除标准
- •Females who are pregnant or breast feeding
- •Any serious medical, or neurological disorder
- •Any psychiatric disorder
- •No major head traumas
研究组 & 干预措施
Regular Users
People who use marijuana regularly will be given a low dose THC marijuana, high dose THC marijuana and placebo marijuana, in a randomized order, at the five study visits.
干预措施: Low Dose THC Marijuana (Drug)
Regular Users
People who use marijuana regularly will be given a low dose THC marijuana, high dose THC marijuana and placebo marijuana, in a randomized order, at the five study visits.
干预措施: High Dose THC Marijuana (Drug)
Regular Users
People who use marijuana regularly will be given a low dose THC marijuana, high dose THC marijuana and placebo marijuana, in a randomized order, at the five study visits.
干预措施: Placebo Marijuana (Drug)
Occasional Users
People who use marijuana occasionally will be given a low dose THC marijuana, high dose THC marijuana and placebo marijuana, in a randomized order, at the five study visits.
干预措施: Low Dose THC Marijuana (Drug)
Occasional Users
People who use marijuana occasionally will be given a low dose THC marijuana, high dose THC marijuana and placebo marijuana, in a randomized order, at the five study visits.
干预措施: High Dose THC Marijuana (Drug)
Occasional Users
People who use marijuana occasionally will be given a low dose THC marijuana, high dose THC marijuana and placebo marijuana, in a randomized order, at the five study visits.
干预措施: Placebo Marijuana (Drug)
结局指标
主要结局
Marijuana induced performance changes on Cogstate 1-back/2-back task.
时间窗: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
The Cogstate 1-back/2-back task assesses working memory, it will be administered prior to dosing and at various time points after dosing.
Marijuana induced performance changes on Cogstate Card Learning.
时间窗: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
The Cogstate Card Learning task assesses visual memory, it will be administered prior to dosing and at various time points after dosing.
Marijuana induced performance changes on the Stop Signal Reaction Time task.
时间窗: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
The Stop Signal Reaction Time Task assesses inhibitory processing, it will be administered prior to dosing and at various time points after dosing.
Marijuana induced performance changes on Cogstate Groton Maze Learning task.
时间窗: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
The Cogstate Groton Maze Learning task assesses spatial learning and memory, it will be administered prior to dosing and at various time points after dosing.
Marijuana induced performance changes on Cogstate Social/Emotional Cognition task.
时间窗: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
The Cogstate Social/Emotional Cognition task assesses emotional processing, it will be administered prior to dosing and at various time points after dosing.
Marijuana induced performance changes on Alertmeter.
时间窗: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
The Alertmeter task assess visual judgment and alertness, it will be administered prior to dosing and at various time points after dosing.
Marijuana induced performance changes on the Time Estimation Task.
时间窗: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
The Time Estimation Task assesses timing, it will be administered prior to dosing and at various time points after dosing.
Marijuana induced performance changes on the Critical Tracking Task.
时间窗: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
The Critical Tracking Task assesses hand eye coordination and visuomotor tracking, it will be administered prior to dosing and at various time points after dosing.
Marijuana induced performance changes on the Finger to Nose Task.
时间窗: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
The Finger to Nose Task assesses general motor coordination, it will be administered prior to dosing and at various time points after dosing.
Marijuana induced performance changes on the One Leg Stand Task.
时间窗: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
The One Leg Stand Task assesses general motor coordination, it will be administered prior to dosing and at various time points after dosing.
Marijuana induced performance changes on the Time Reproduction Task.
时间窗: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
The Time Reproduction Task assesses general motor coordination plus timing, it will be administered prior to dosing and at various time points after dosing.
Marijuana induced performance changes on the ANAM Pursuit Tracking Task.
时间窗: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
The ANAM Pursuit Tracking Task assesses hand eye coordination, it will be administered prior to dosing and at various time points after dosing.
Marijuana induced performance changes on the Line Walking/Months Backwards Task.
时间窗: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours
The Line Walking/Months Backwards Task assesses general motor coordination plus distraction, it will be administered prior to dosing and at various time points after dosing.
次要结局
- Change in performance on simulated driving Car Following Task.(Post drug administration at: 1 hour, 3 hours and 5 hours)
- Change in concentration of THC/metabolites in blood samples.(Baseline and post drug administration at: 5 min, 20 min, 1 hr 10 min, 1 hr 45 min, 2 hrs 30 min, 4 hrs, and 6 hrs 30 min.)
- Change in concentration of THC/metabolites in oral fluid tested using Draeger Drug Detection Kits.(Baseline and post drug administration at: 5 min, 20 min, 1 hr 10 min, 1 hr 45 min, 2 hrs 30 min, 4 hrs, and 6 hrs 30 min.)
- Change in concentration of THC/metabolites in oral fluid tested using Quantisal Oral Fluid Collection devices.(Baseline and post drug administration at: 5 min, 20 min, 1 hr 10 min, 1 hr 45 min, 2 hrs 30 min, 4 hrs, and 6 hrs 30 min.)
- Change in performance on simulated driving Road Tracking Task.(Post drug administration at: 1 hour, 3 hours and 5 hours)
- Change in performance on simulated driving Gap Acceptance Task.(Post drug administration at: 1 hour, 3 hours and 5 hours)
研究者
Godfrey Pearlson
Principal Investigator
Yale University