Cannabinoids and Cerebellar-Motor Functioning
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Cerebellum Dependent Associative Learning (% CRs)
研究概览
简要总结
The purpose of this study is to characterize the dose-related effects of delta-9-tetrahydrocannabinol (∆9-THC) in healthy individuals on cerebellum-dependent motor functions.
详细描述
The overall aim of the current proposal is to investigate whether acute, IV ∆9-THC administration mediates cerebellar versus forebrain-dependent associative learning in humans as assessed with eyeblink conditioning (EBC). In addition, a battery of motor function tests will also be administered (the CANTAB motor screening test, Grooved Pegboard Motor Task, paced finger tapping).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must have used cannabis at least once in their lifetime
- •No cannabis use in the past month
- •Men and women aged 21 to 35 years (extremes included) on the day of the first dosing
排除标准
- •Hearing deficits
- •Psychiatric or mental disorders
- •Hearing Deficits
研究组 & 干预措施
THC
Very low dose (0.0015 mg/kg = 0.21 mg in a 70 kg individual) THC, dissolved in alcohol. Administered intravenously over 10 minutes.
Low dose (0.015 mg/kg = 1.05 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately ¼ of a marijuana cigarette, or "joint". Administered intravenously over 10 minutes.
Medium dose (0.03 mg/kg = 2.1 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately ½ of a marijuana cigarette, or "joint". Administered intravenously over 10 minutes.
干预措施: THC (Drug)
Placebo
Control: small amount of alcohol intravenous (quarter teaspoon), with no THC over 10 minutes
干预措施: Placebo (Drug)
结局指标
主要结局
Cerebellum Dependent Associative Learning (% CRs)
时间窗: Measured +15 minutes after infusion
% conditioned responses (CRs) will be measured
Cerebellum Dependent Associative Learning (CR Latency)
时间窗: Measured +15 minutes after infusion
conditioned response (CR) Latency will be measured
Completion of the Grooved Pegboard Motor Task (Reaction Time/Accuracy)
时间窗: Measured +45 minutes after infusion
Total time taken to complete the grooved pegboard tasks will be the dependent measure.
Paced Finger Tapping (Correct Responses)
时间窗: Measured +45 minutes after infusion
Using a button on a computer keyboard, correct responses will be measured.
Paced Finger Tapping (Reaction Time)
时间窗: Measured +45 minutes after infusion
Using a button on a computer keyboard, reaction time and tapping variability will be measured.
CANTAB Motor Screening Test (Reaction Time)
时间窗: Measured +45 minutes after infusion
Using a touch screen, reaction time to touch a target will be the dependent measures.
CANTAB Motor Screening Test (Accuracy)
时间窗: Measured +45 minutes after infusion
Using a touch screen, accuracy to touch a target will be the dependent measures.
次要结局
- THC intoxication, as measured by the Visual Analog Scale (Total Score)(Baseline; +45, +100, +240 minutes after infusion)
研究者
Patrick D. Skosnik
Assistant Professor
Yale University